Testicular Cancer

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Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)


Condition: Testicular Cancer

Purpose: Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy, alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates are above 90% nowadays, which results in growing TC survivor population. Because of the long life expectancy of these survivors, prevention or early detection of late treatment effects has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity, Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an important late effect, but data is lacking in very long-term survivors since performed studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk factor for CVD development and also an association between renal function and neurtoxicity via circulating platinum levels has been shown. It is hypothesized that treatment induced nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late effects. The secondary aim is to assess prevalence of late effects in very long-term TC survivors: until now, most data have been collected through questionnaires in large epidemiological studies in TC survivors till approximately 10 years after treatment. The prevalence of late effects may increase over time: 10 years after treatment late effects may not be present yet, whilst late effects can emerge just after 20 years. Consequently, health status and possible late effects, resulting in morbidity, are underestimated in patients who are 20-30 years after treatment. By investigating health status of these very long-term survivors a more profound insight in the prevalence and aetiology of these late effects and the development over time can be assessed. Current treatment is very similar to TC treatment 20-30 years ago and therefore knowledge on late effects is relevant for currently treated patients. Furthermore, as a result of this study, we will better understand which factors and issues should be watched closely during follow-up, which TC survivors are at increased risk of developing late treatment effects and how to detect early damage before overt morbidity occurs.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02572934

Sponsor: University Medical Center Groningen

Primary Outcome Measures:

  • Measure: Glomerular filtration rate (GFR) in ml/min
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Development of cardiovascular disease (CVD) according to the WHO ICD-10 classification (I10-I15: hypertensive disease; I20-I25: ischemic heart disease; I60-I69: cerebrovascular disease; I70-I79: disease of arteries, arterioles and capillaries)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Raynaud's phenomenon (anamnestic with SCIN questionnaire which assesses a.o. Raynaud's phenomenon and objectified with standardized digital cooling tests)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO))
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Cognitive function (neuropsychological assessment of different domains: learning, memory, processing speed, executive function)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Fatigue (scaled; VVV-questionnaire)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Testicular cancer disease characteristics: stage, prognosis group, chemotherapy regimen/dose, radiotherapy doses/location
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Health-related quality of life (HRQoL)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Physical fitness (according to six-minute walk test with sex, age and BMI specific reference values)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Intima media thickness (IMT)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Advanced Glycation End products (AGEs)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Cardiovascular risk factors (presence of hypertension, dyslipidemia, impaired fasting glucose, overweight/obesity, tobacco and alcohol use, family history)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Genetic susceptibility for (cardio)vascular damage (single nucleotide polymorphisms (SNPs) in DNA)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Leukocyte telomere length
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Arterial stiffness measured as pulse-wave velocity (PWV)
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 280

Study Start Date: August 2015

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Eligibility:

  • Age: minimum 18 Years maximum 70 Years
  • Gender: Male

Inclusion Criteria:

  1. Age <70 years at time of inclusion
  2. Signed informed consent
  3. CT-, RT- and SU-group: Age at start of TC treatment <40 yrs.
  4. CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion.
  5. CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group).
  6. RT-group: Patients treated with radiotherapy for TC stage I or II.
  7. SU-group: Patients treated with orchidectomy only for TC stage I.

Exclusion Criteria:

  1. Mental disorder (no informed consent available).
  2. CT-group: Patients also treated with radiotherapy for TC.
  3. RT-group: Patients also treated with chemotherapy for TC.
  4. SU-group: Patients also treated with chemo- or radiotherapy for TC.
  5. CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.

Contact:

  • Jourik Gietema, MDPhD
  • 0031 (0)50-3612821

Location:

  • University Medical Center Groningen
  • Groningen 9713 GZ Netherlands

View trial on ClinicalTrials.gov


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A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis


Condition: Germ Cell Tumour

Intervention:

  • Drug: Combination Chemotherapy

Purpose: The treatment of germ cell tumours is considered to be one of the major successes in the area of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a durable remission rate of between 25% and 60% has been seen using further chemotherapy. In 1999, researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results from this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. When we reviewed the individual patients it was clear that older patients (>35yrs) or patients with a raised Lactate Dehydrogenase (a blood test that monitors cancer activity), did not do as well. In addition, patients whose original tumour started in their chest (mediastinal germ cell tumour) have tended to do badly if they relapse. We have been developing a study for patients who fulfil at least one of these criteria. The GAMIO study (filgrastim, actinomycin D, methotrexate, irinotecan, oxaliplatin) has recently closed due to problems with high levels of toxicity from the irinotecan. GAMMA is a new study that will use paclitaxel instead of irinotecan and oxaliplatin instead of cisplatin. We expect that this treatment with oxaliplatin will be less damaging to the kidneys than cisplatin. Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have similar activity in relapsed patients in the phase II setting. We hope to improve on our previous results with this substitution and see if this will lead to an improvement in the cure rate of relapsed germ cell tumours with poor prognosis and reduce the side effects compared to our standard treatment. In addition, we do not expect any hearing damage and the treatment requires a shorter hospital stay.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01782339

Sponsor: Barts & The London NHS Trust

Primary Outcome Measures:

  • Measure: Objective response rate
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression Free Survival
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Overall Survival
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Toxicity Level
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 43

Study Start Date: July 2012

Phase: Phase 2

Eligibility:

  • Age: minimum 16 Years maximum 65 Years
  • Gender: All

Inclusion Criteria:

  • Germ Cell Tumour (GCT)
  • Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on PET CT Scan prior to entering study)
  • Neutrophil count >1.0x109/l
  • Platelets >70x109/l
  • Haemoglobin >100g/l (may be transfused)
  • Glomerular filtration rate >40ml/min (determined by EDTA clearance or calculated creatinine clearance using the Cockcroft
  • Gault equation if unable to perform EDTA clearance)
  • Males and females aged 16-65 years a) Male patients must have IGCCCG2 prognostic score, low to very high
  • Patients must be sterile or agree to use adequate contraception during the period of therapy
  • ECOG Performance status 0-3
  • Able and willing to give written informed consent and comply with the protocol study procedures.

Exclusion Criteria:

  • Other malignancy except basal cell carcinoma
  • Significant co-morbidity likely to make delivery of this treatment unsafe
  • Currently enrolled in any other investigational drug study
  • Previous chemotherapy with oxaliplatin, methotrexate or Actinomycin D
  • Patients who have peripheral neuropathy with functional impairment

Contact:

  • GAMMA Coordinator
  • +44 (0)20 7882 8762

Location:

  • St Bartholomew's Hospital
  • London EC1A 7BE United Kingdom

View trial on ClinicalTrials.gov


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A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors


Condition: Non-seminomatous Germ-cell Tumors

Intervention:

  • Drug: Cabazitaxel

Purpose: Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs. Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02115165

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Primary Outcome Measures:

  • Measure: Favorable response
  • Time Frame: Assessed every 6 weeks from start of treatment up to 72 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Response rate on brain metastases
  • Time Frame: Assessed every 6 weeks after treatment start up to 72 months
  • Safety Issue:
  • Measure: Progression free survival
  • Time Frame: Assessed every 6 weeks from treatment start to progression up to 72 months
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Assessed every 3 weeks after treatment start up to 72 months
  • Safety Issue:

Estimated Enrollment: 34

Study Start Date: May 2014

Phase: Phase 2

Eligibility:

  • Age: minimum 15 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Male patients aged 15 years or older
  • Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation
  • Primary site located in either the testis, the retroperitoneum or the mediastinum
  • Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I)
  • In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents
  • No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin
  • Life expectancy >/= 3 months
  • Adequate hematologic function :
  • Hemoglobin >/= 10.0 g/dL
  • Absolute neutrophil count >/= 1.5 x 10 ^ 9/L,
  • Platelet count >/= 100 x 10 ^ 9/L,
  • Adequate organ function
  • Serum creatinine < 1.5 x ULN. If serum creatinine 1.0
  • 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) > 60 mL/min
  • AST/SGOT and ALT/SGPT
  • Bilirubin
  • Information delivered to patient and informed consent form signed by the patient or his legal representative
  • Patient affiliated to a social security system or beneficiary of the same

Exclusion Criteria:

  • Patients receiving anti cancer therapy within 4 weeks prior to enrolment
  • Previous radiotherapy within 4 weeks prior to enrolment
  • Serious uncontrolled concurrent medical illness
  • History of severe hypersensitivity reaction (>/= grade 3) to polysorbate 80 containing drugs or to other taxanes
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments.
  • Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel.
  • Active Grade >/= 3 peripheral neuropathy
  • Patients who have had a major surgery within 4 last weeks prior enrolment
  • Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed

Contact:

  • Karim FIZAZI, MD-PhD
  • 0142116264 Ext. +33

Location:

  • Gustave Roussy Cancer Campus Grand Paris
  • Villejuif Val de Marne 94805 France

View trial on ClinicalTrials.gov


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Multidisciplinary Etiologic Study of Familial Testicular Cancer


Condition: Testicular Cancer

Purpose: Background: People with a family history of testicular cancer may be at increased risk for the disease. Genetic and clinical studies of patients with testicular cancer and their family members may help clarify the cause of the disease and identify clinical features. Objectives: To characterize the clinical features of testicular cancer. To identify genes that may lead to increased risk of the disease. To examine emotional and behavioral issues of members of families at increased risk of the disease. Eligibility: Males and females from a family with at least two cases of testicular cancer in blood relatives. Males with testicular cancer in both testicles. Males with testicular cancer who have an identical twin. Participants must be at least 12 years of age. Design: Participants may take part in Part 1 or Parts 1 and 2 of this 2-part study. Part 1 participants: - Provide a blood or cheek cell sample to obtain DNA for gene studies. - Provide permission for researchers to obtain their medical records for review. - Complete questionnaires about their personal and family medical history, exposure to factors that might influence the risk of testicular cancer, and their feelings about being a member of a family in which several members have testicular cancer. - These data are collected from participants in their home communities. Part 2 participants: - All participants provide a medical history, have a complete physical examination, including routine lab tests, and have an ultrasound test of the abdomen to look at the kidneys. - Males have an ultrasound test of the testicles and scrotum. - Females have an ultrasound test of the pelvis to look at the ovaries, uterus and fallopian tubes. - Males 18 years of age and older provide a semen sample. - Some participants have computed tomography (CT) scanning of the chest, abdomen and pelvis instead of kidney ultrasound. Children under 18 years of age may have magnetic resonance imaging (MRI) instead of CT. - These data are collected from participants during a 2-day visit to the NIH Clinical Center in Bethesda, MD. Travel costs are covered by the protocol.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00034424

Sponsor: National Cancer Institute (NCI)

Primary Outcome Measures:

  • Measure: Families with Familial Testicular Germ Cell Tumors
  • Time Frame: Ongoing
  • Safety Issue:
  • Measure: Clinical Features
  • Time Frame: Ongoing
  • Safety Issue:
  • Measure: Genetic Mechanisms
  • Time Frame: Ongoing
  • Safety Issue:
  • Measure: Psychosocial Factors
  • Time Frame: Ongoing
  • Safety Issue:

Estimated Enrollment: 1750

Study Start Date: April 6, 2002

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Eligibility:

  • Age: minimum 12 Years maximum 100 Years
  • Gender: All

Inclusion Criteria:

  • Study population: Patients must be members of families with familial TGCT as defined below. Definition of familial TGCT: The criterion establishing familial TGCT is the presence of: -at least two cases of documented GCT in blood relatives (at least one of which is testicular in origin), OR
  • a single family member with bilateral testicular cancer,
  • men with a history of TGCT who are one in a set of identical siblings will also be included in the study. Case definition: A case will be determined to have TGCT according to the following criteria:
  • Pathologic confirmation of a germ cell derived tumor arising in the testis. Extragonadal germ cell tumors will also be included.
  • Germ cell derived histologies including: seminoma, germinoma, embryonal carcinoma, endodermal sinus (yolk sac) tumor, gonadoblastoma, choriocarcinoma, teratoma, and mixed germ cell tumor.
  • A case will be determined to have TIN on the basis of pathologic confirmation of intratubular malignant germ cells (ITMGCs) as defined by Burke and Mostofi. Individuals from participating families who are eligible for this study include: i) all TGCT cases; ii) All GCT cases (including those of ovarian or extra-gonadal sites); iii) all first-degree relatives of each TGCT case; iv) the spouse(s) of every case if the spouse and case had children who are participating in the study; v) any blood relative not included in (ii
  • iii) above who genetically links two cases; and vi) any blood relative with cancer other than TGCT vii) family members as described in i)
  • v) above must be age 12 or greater in order to participate

Exclusion Criteria:

  1. Families will be deemed ineligible for participation in this study if: There are not at least two proven cases of GCT in the family, one of which is testicular in origin, unless there is a family member with bilateral testicular cancer; Deceased TGCT cases lacking both archival sources of tissue for DNA extraction AND lacking surviving spouses and children who are willing to paricipate in the study (unavailability of such persons prohibits inferring the genotype of the deceased individual with TGCT). Critical informative family members are unwilling to participate (i.e., unwilling to provide written informed consent);

Contact:

  • Jennifer T Loud, C.R.N.P.
  • (301) 594-7642

Location:

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
  • Bethesda Maryland 20892 United States

View trial on ClinicalTrials.gov


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Surgery in Early Metastatic Seminoma (SEMS): Phase II Trial of Retroperitoneal Lymph Node Dissection as First-Line Treatment for Testicular Seminoma With Isolated Retroperitoneal Disease (1-3cm)


Condition: Lymphadenopathy, Stage I Testicular Seminoma, Stage II Testicular Seminoma

Intervention:

  • Other: Laboratory Biomarker Analysis
  • Procedure: Retroperitoneal Lymph Node Dissection

Purpose: This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02537548

Sponsor: University of Southern California

Primary Outcome Measures:

  • Measure: RFS
  • Time Frame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Long-term RPLND complication rates
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: RFS
  • Time Frame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 5 years after RPLND
  • Safety Issue:
  • Measure: Short-term RPLND complication rates
  • Time Frame: Up to 12 months
  • Safety Issue:

Estimated Enrollment: 55

Study Start Date: August 28, 2015

Eligibility:

  • Age: minimum 16 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Pure seminoma after orchiectomy presenting with isolated retropreritoneal lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse. Relapse should be within 3 years
  • Lymphadenopathy in the retroperitoneum: at least one lymph node 1-3 cm in greatest dimension, no lymph node > 3 cm in greatest dimension, no more than 2 lymph nodes 1-3 cm in greatest dimension
  • Axial imaging of lymphadenopathy within 6 weeks of the date of RPLND
  • Retroperitoneal lymphadenopathy must be within the RPLND template
  • If there is borderline lymphadenopathy, defined as the largest retroperitoneal lymph node measuring 0.90
  • 0.99 cm in the greatest dimension, an abdominal computed tomography (CT) scan should be repeated (recommend interval of 6
  • 8 weeks); the same lymph node must demonstrate growth to >= 1.0 cm in the greatest dimension
  • Biopsy is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with pure seminoma
  • Chest imaging (x-ray, CT or magnetic resonance imaging [MRI]) negative for metastasis no more than 6 weeks prior to the date of RPLND
  • Primary tumor excised by radical inguinal orchiectomy and pathology consistent with pure seminoma
  • Serum alpha fetoprotein (AFP) not more than 1.5 times upper limit of normal, beta-human chorionic gonadotropin (HCG), lactate dehydrogenase (LDH) (per the local laboratory assay) within 14 days of RPLND
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Ability to understand and the willingness to sign a written informed consent
  • Serum coagulation studies (INR/PTT) and platelet counts suitable for surgery per surgeon discretion.

Exclusion Criteria:

  • Second primary malignancy
  • History of receiving chemotherapy or radiotherapy
  • Patients receiving any other investigational agent (s)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Contact:

  • Ileana Aldana
  • 323-865-0702

Locations:

  • Loma Linda University Medical Center
  • Loma Linda California 92350 United States
  • USC / Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • University of California, San Francisco
  • San Francisco California 94143 United States
  • Stanford University Hospitals & Clinics
  • Stanford California 94305 United States
  • University of Colorado Hospital - Aurora
  • Aurora Colorado 80045 United States
  • Emory University
  • Atlanta Georgia 30322 United States
  • University of Chicago Medical Center
  • Chicago Illinois 60637 United States
  • Indiana University
  • Indianapolis Indiana 46202 United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Baltimore Maryland 21205 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • Rutgers Cancer Institute of New Jersey
  • New Brunswick New Jersey 08903-2681 United States
  • Stephenson Cancer Center, University of Oklahoma
  • Oklahoma City Oklahoma 73104 United States
  • UTSouthwestern Medical Center
  • Dallas Texas 75390-9110 United States
  • Madigan Army Medical Center
  • Tacoma Washington 98431 United States

View trial on ClinicalTrials.gov


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Vascular Fingerprint to Identify Patients at Risk for Arterial Cardiovascular Events Within the First Year After Start of Cisplatin-based Chemotherapy for Testicular Cancer: a Validation Study


Condition: Testicular Cancer

Purpose: The vascular fingerprint is a simple selection tool to identify testicular cancer patients with a high risk of arterial cardiovascular events during and in the first year after cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety in lowering the chance of an arterial cardiovascular event.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02573584

Sponsor: University Medical Center Groningen

Primary Outcome Measures:

  • Measure: Development of arterial cardiovascular events
  • Time Frame: first year after start of chemotherapy
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: first year after start of chemotherapy
  • Safety Issue:
  • Measure: Response to testicular cancer treatment (no evidence of disease / relapse / no response to treatment)
  • Time Frame: first year after start of chemotherapy
  • Safety Issue:
  • Measure: Development of venous thromboembolic events (VTE) (WHO ICD-10 I26, I80-82)
  • Time Frame: first year after start of chemotherapy
  • Safety Issue:

Estimated Enrollment: 178

Study Start Date: October 2015

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Eligibility:

  • Age: minimum 18 Years maximum 50 Years
  • Gender: Male

Inclusion Criteria:

  1. Diagnosis of metastatic TC and an indication to start with first-line cisplatin-based chemotherapy for metastatic TC
  2. Classified into IGCCCG good or intermediate prognosis group
  3. Younger than 50 years of age at start of chemotherapy
  4. Signed informed consent

Exclusion Criteria:

  1. History of previous cardiovascular disease
  2. Retroperitoneal mass > 5 cm
  3. Indication for anticoagulant therapy at start of chemotherapy

Contact:

  • Jourik A Gietema, MD, PhD
  • +31 503616161

Locations:

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek ziekenhuis (NKI-AVL)
  • Amsterdam Netherlands
  • University Medical Center Groningen (UMCG)
  • Groningen Netherlands
  • Maastricht University Medical Center (MUMC)
  • Maastricht Netherlands
  • Instituto Portuges de Oncologia Francisco Gentil (IPOLFG)
  • Lisbon Portugal
  • UniversitatsSpital Zurich
  • Zurich Switzerland

View trial on ClinicalTrials.gov


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Testicular Tissue Cryopreservation for Fertility Preservation in Males Facing Fertility Threatening Diagnoses or Treatment Regimens


Condition: Cancer

Intervention:

  • Procedure: Testicular tissue cryopreservation

Purpose: This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02872532

Sponsor: Mayo Clinic

Primary Outcome Measures:

  • Measure: Number of pregnancies and live births after transplantation of cryopreserved testicular tissue
  • Time Frame: 10-20 years
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: August 16, 2016

Eligibility:

  • Age: minimum N/A maximum 17 Years
  • Gender: Male

Inclusion Criteria:

  • (All inclusion criteria must be met.) 1. Be male 0-17 years of age. 2. Meet at least one of the following four conditions: a. Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function. Risk categories based on treatment regimens are indicated below. Investigators will utilize three sources to calculate risk: 1."Fertile Hope
  • Risks of Azoospermia" brochure that details typical agents and treatment regimens in each risk category, 2. the Summed Alkylating Agent dose score, or 3. the Cyclophosphamide Equivalent Dose method. Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators. i. High Risk (1. ≥80% risk of prolonged azoospermia, Fertile Hope Brochure; 2. Summed alkylating agent dose score ≥3; 3. Cyclophosphamide equivalent dose ≥7,500mg/m2). ii. Intermediate Risk (21-79% risk of prolonged azoospermia, Fertile Hope). iii. Low Risk (≤20% risk of prolonged azoospermia, Fertile Hope). iv. Eligibility is limited to patients in the High Risk category. b. Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles. c. Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome). d. Or, have a newly diagnosed or recurrent disease affecting fertility. Those who were not enrolled at the time of initial diagnosis (i.e. patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function. 3. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. 4. Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. 5. Consent for serum screening tests for infectious diseases to be performed at the time of testicular tissue harvesting. The immediate testing will include but not be limited to testing for Hepatitis B, Hepatitis C, and HIV. 6. Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon. Exclusion Criteria: (Any

Exclusion Criteria:

  1. (Any exclusion criteria will disqualify.)
  2. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  3. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
  4. Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.

Location:

  • Mayo Clinic in Rochester
  • Rochester Minnesota 55905 United States

View trial on ClinicalTrials.gov


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A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)


Condition: Metabolic Syndrome, Testicular Cancer, Leydig Cell Failure in Adult

Intervention:

  • Drug: Testosterone
  • Drug: Placebos

Purpose: The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease. The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02991209

Sponsor: Mikkel Bandak

Primary Outcome Measures:

  • Measure: Changes in insulin sensitivity
  • Time Frame: 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Changes in fasting plasma lipids between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in BMD and fat percent between baseline 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in systemic inflammation between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in plasma-adipocytokines between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in fasting plasma glucose between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in Quality of life between baseline and 52 weeks.
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in prevalence of metabolic syndrome between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in haemoglobin A1c between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in plasma insulin between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in fatigue between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in Anxiety and depression between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 70

Study Start Date: November 2016

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 65 Years
  • Gender: Male

Inclusion Criteria:

  • Signed informed consent.
  • Previous treatment for testicular cancer.
  • No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).
  • Free testosterone < the age-adjusted median and > -2 standard deviations (SD) from the age-adjusted median and LH > 2 SD from the age-adjusted median.

Exclusion Criteria:

  • Treatment with testosterone within the last 6 months.
  • Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) > 50%.
  • Breast cancer.
  • Symptomatic obstructive sleep apnoea syndrome
  • Heart failure > NYHA II.
  • Uncontrolled hypertension: (Systolic blood pressure > 160 mm Hg despite antihypertensive treatment, measured at two separate occasions)
  • Inability to understand information about the trial
  • Participation in any other clinical trial
  • Allergy for the active substance or additives in Tostran or placebo.
  • Known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.

Contact:

  • Mikkel Bandak, MD
  • +453545 6354

Location:

  • Rigshospitalet
  • Copenhagen 2100 Denmark

View trial on ClinicalTrials.gov


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Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors


Condition: Intracranial Non-germinomatous Germ Cell Tumor

Intervention:

  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Cyclophosphamide
  • Drug: Bleomycin
  • Drug: Thiotepa
  • Drug: Melphalan
  • Radiation: Reduced dose radiotherapy

Purpose: The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02784054

Sponsor: Samsung Medical Center

Primary Outcome Measures:

  • Measure: Rate of event free survival
  • Time Frame: Up to 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Rate of late adverse events
  • Time Frame: Up to 5 years
  • Safety Issue:

Estimated Enrollment: 25

Study Start Date: April 2014

Phase: Phase 2

Eligibility:

  • Age: minimum 3 Years maximum 30 Years
  • Gender: All

Inclusion Criteria:

  • Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
  • Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.

Exclusion Criteria:

  • Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).
  • Pregnant or nursing women

Contact:

  • Ki Woong Sung, MD, PhD
  • 82-2-3410-3529

Location:

  • Samsung Medical Center
  • Seoul Korea, Republic of

View trial on ClinicalTrials.gov


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Multimodality Therapy With Induction Carboplatin/Nab-Paclitaxel/Durvalumab Followed by Surgical Resection and Risk-adapted Adjuvant Therapy for the Treatment of Locally-Advanced and Surgically Resectable Squamous Cell Carcinoma of the Head and Neck


Condition: Carcinoma, Squamous Cell, Oral Cancer, Oropharynx Cancer, Larynx Cancer, Lip Cancer, Esophageal Cancer

Intervention:

  • Drug: Durvalumab
  • Drug: Carboplatin
  • Drug: Nab-paclitaxel
  • Drug: Cisplatin
  • Procedure: Surgical resection
  • Radiation: IMRT

Purpose: Participants in this study have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This is called locally-advanced SCCHN. These participants are eligible for surgery. Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage, high rates of avoiding radiation and its side effects, high cure rate and good quality of life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If the participants are not on this study they would be receiving radiation as it is standard treatment of their cancer. In the last study with a similar regimen, about a third of cancers had a pathologic complete response with the first part of the study. This means that the chemotherapy had killed the cancer. The investigators are trying to improve the regimen further with a goal of increasing this rate of complete response to the first part of therapy. The investigators also hope that by improving results in the first part, that more people will be cured and that long term quality of life (especially speech and swallowing) will be improved, both compared to standard therapies and to the last study. Doctors do not know how this therapy will effect the participants. There is no guarantee that this study will benefit the participants. The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and a third targeted anti-cancer drug. In this study the investigators are testing the combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound paclitaxel has been shown to be more active against other types of squamous cancers than regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to fight the cancer. Doctors hope that combining Durvalumab with 2 chemotherapy drugs will be effective in treating SCCHN. Durvalumab on its own has been studied in patients with SCCHN and initial results have shown that some subjects' cancer has responded to it. The purpose of this study is to test a combination of chemotherapy to hopefully both increase the number of subjects that respond to therapy while also decreasing the number of side effects that subjects experience.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03174275

Sponsor: UNC Lineberger Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Pathologic complete response rate (pCRR) after induction chemotherapy with carboplatin, nab-paclitaxel, and durvalumab in previously untreated stage III and IV SCCHN amenable to surgical resection
  • Time Frame: After surgery (approximately 8-12 weeks after start of study treatment)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Clinical complete response rate and (cCRR) and clinical response rate (cRR) following induction chemotherapy
  • Time Frame: 1-4 weeks post induction chemotherapy
  • Safety Issue:
  • Measure: Percent of patients who have a change in estimated risk level
  • Time Frame: After surgery (approximately 8-12 weeks after start of study treatment)
  • Safety Issue:
  • Measure: Progression free survival (PFS) associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Overall survival (OS) associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Toxicity profile associated with both induction therapy and total 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation
  • Time Frame: 90 days after the last dose of study treatment
  • Safety Issue:

Estimated Enrollment: 39

Study Start Date: December 19, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Previously untreated, histologically proven, surgically resectable primary squamous cell carinoma of the head and neck, stage III or IV (HPV positive or negative non-metastatic disease). SCCHN of unknown primary is excluded. SCCHN of the oral cavity is allowed*. Unambiguously squamous Epstein-Barr virus (EBV)-negative nasopharynx cancer will be excluded nor will unambiguously squamous cancers of the skull base that are clearly surgically resectable and clearly squamous. Squamous skin cancer occurring in the head/neck region will not be eligible nor will EBV+positive nasopharynx cancer. (*Note: Induction chemotherapy is not considered standard therapy for SCCHN of the oral cavity and participation on this trial will lead to a delay in time to definitive, potentially curative therapy i.e., surgery).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Measurable disease as per RECIST 1.1
  • Age greater than or equal to 18 at time of study entry
  • Adequate bone marrow function as demonstrated by:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Hgb > 10 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable)
  • Platelet count ≥ 100,000/mm3
  • Adequate hepatic and renal function as demonstrated by:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN);
  • Total serum bilirubin ≤1.5 x ULN
  • Creatinine clearance (CrCL) > 40 mL/min as measured via Cockcroft-Gault
  • Males: Creatinine CL (mL/min) = (Weight (kg) x (140
  • Age))/(72 x serum creatinine (mg/dL))
  • Females: Creatinine CL (mL/min) = (Weight (kg) x (140
  • Age))/(72 x serum creatinine (mg/dL)) x 0.85
  • Negative serum β human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential.
  • All males and females of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy or bilateral oophorectomy. See section 4.13 for list of acceptable methods of contraception.
  • Signed an institutional review board (IRB)-approved informed consent and HIPAA authorization.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition, subjects must consent to allow use of their residual post-operative tissue for research purposes.

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to staff at the study site) or previous enrollment in the present study.
  • Any metastatic disease.
  • Known history of previous clinical diagnosis of tuberculosis.
  • History and/or confirmed pneumonitis.
  • Low-risk HPV+ disease of the oropharynx, defined as meeting all of the following criteria:
  • Patients with known HPV+ by fluorescence in situ hybridization (FISH) and/or p16
  • Smoking history ≤ 10 pack years
  • Stage T1-2N0-2b, T3N0
  • Not considered eligible for any of the chemotherapy agents included in the induction regimen.
  • Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).
  • Major surgery within 28 days prior to day 1 of study treatment from which the patient has not completely recovered.
  • Receiving any investigational agent currently or within 28 days or 5 half-lives of Day 1 of treatment on this study, whichever is shorter.
  • Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis;; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 2 years prior to the start of treatment. [Note: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded]
  • Known mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction. (Note that ECG is not required for study entry and is not part of study procedures).
  • Other prior or concomitant malignancies with the exception of:
  • Non-melanoma skin cancer
  • In-situ malignancy
  • Low-risk prostate cancer after curative therapy
  • Other cancer for which the patient has been disease free for ≥ 5 years before the first dose of study drug and of low potential risk for recurrence.
  • Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent.[Note: If systemic corticosteroids are part of the treatment regimen for the indication under study, the systemic corticosteroid is permitted].
  • Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
  • History of hypersensitivity to durvalumab or any excipient.
  • Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab [Note: If a vaccine is part of the treatment regimen for the indication under study, the vaccine is permitted].
  • Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting dose of study medications (Cycle 1 Day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.
  • Male subjects who are not employing an effective method of birth control from starting dose of study medications (Cycle 1 Day 1), including dosing interruptions through 6 months after receipt of study treatment. Male subjects should agree to refrain from sperm donation while taking study treatment and for at least 6 months after the last dose of nab-paclitaxel and at least 90 days after the last dose of durvalumab. Should a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study, he should inform his treating physician and the female partner should call her physician immediately.
  • Any previous treatment with a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, including durvalumab.
  • History of primary immunodeficiency.
  • History of organ transplant.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results (eg, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent).
  • Patients with known contraindications to radiotherapy including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia Telangiectasia, Nijmegen Breakage Syndrome).

Contact:

  • Chris Hilliard
  • (919) 843-6752

Locations:

  • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
  • Chapel Hill North Carolina 27599 United States
  • Vanderbilt University Medical Center
  • Nashville Tennessee 37232 United States

View trial on ClinicalTrials.gov


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NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With Nivolumab PD-1 Blockade


Condition: Adult Solid Neoplasm, Childhood Solid Neoplasm, Metastatic Neoplasm

Intervention:

  • Biological: Aldesleukin
  • Drug: Cyclophosphamide
  • Drug: Fludarabine Phosphate
  • Other: Laboratory Biomarker Analysis
  • Biological: Nivolumab
  • Biological: NY-ESO-1 Reactive TCR Retroviral Vector Transduced Autologous PBL
  • Biological: NY-ESO-1(157-165) Peptide-pulsed Autologous Dendritic Cell Vaccine
  • Procedure: Positron Emission Tomography

Purpose: This phase I trial studies the side effects and the best dose of nivolumab when given together with gene-modified T cells and vaccine therapy in treating patients with solid tumors that express the cancer-testes antigen NY-ESO-1 gene AND have spread from where it started to nearby tissue or lymph nodes (locally advanced) or distant organs (stage IV). T cells are a special type of white blood cells (immune cell) that have the ability to kill cancer cells. Nivolumab may block PD-1 which is found on T cells and help the immune system kill cancer cells. Placing a modified gene for the NY-ESO-1 T cell receptor (TCR) into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Dendritic cells are another type of blood cell that can teach other cells in the body to look for cancer cells and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer. Giving nivolumab together with gene-modified T-cells and dendritic cell vaccine may teach the immune system to recognize and kill cancer cells that express NY-ESO-1.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02775292

Sponsor: Jonsson Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Incidence of adverse events, defined following the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
  • Time Frame: Up to 15 years
  • Safety Issue:
  • Measure: Maximum tolerated dose based on dose-limiting toxicity using the Common Toxicity Criteria
  • Time Frame: First 60 days after ACT
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Feasibility of generating NY-ESO-1 TCR cells and/or NY-ESO 1(157-165) peptide pulsed DC vaccine, determined by the incidence of preparation not meeting the lot release criteria
  • Time Frame: 1 month
  • Safety Issue:
  • Measure: Transgenic cell persistence
  • Time Frame: Up to 15 years
  • Safety Issue:

Estimated Enrollment: 12

Study Start Date: January 3, 2017

Phase: Phase 1

Eligibility:

  • Age: minimum 16 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Stage IV or locally advanced histologically confirmed solid tumors for which no alternative therapies with proven survival advantage are available
  • At least 1 lesion amenable for outpatient biopsies; this should be a cutaneous or palpable metastatic site or a deeper site accessible by image-guided biopsy that is deemed safe to access by the treating physicians and interventional radiologists; patients without accessible lesions for biopsy but with prior tissue available from metastatic disease would be eligible at the investigator's discretion
  • NY-ESO-1 positive malignancy by immunohistochemistry (IHC) utilizing commonly available NY-ESO-1 antibodies
  • Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping
  • Age greater than or equal to 16 years old
  • A minimum of one measurable lesion defined as:
  • Meeting the criteria for measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
  • Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Absolute neutrophil count >= 1.5 x 10^9 cells/L
  • Platelets >= 100 x 10^9/L
  • Hemoglobin >= 9 g/dL
  • Aspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN, if documented liver metastases are present)
  • Total bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)
  • Creatinine < 2 mg/dl (or a glomerular filtration rate > 60)
  • Must be willing and able to accept two leukapheresis procedures
  • Must be willing and able to provide written informed consent

Exclusion Criteria:

  • Previously known hypersensitivity to any of the agents used in this study
  • Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol
  • History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
  • History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin
  • Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment (inhaled or topical steroids at standard doses are allowed)
  • Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
  • Hepatitis B or C seropositivity with evidence of ongoing liver damage; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
  • Known clinically active brain metastases; prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment and there are no neurological signs of potential brain metastases
  • Pregnancy or breast-feeding; female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and 6 months after; all female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 24 hours from starting the conditioning chemotherapy; the definition of effective contraception will be based on the judgment of the study investigators; patients who are breastfeeding are not allowed on study
  • Since IL-2 is administered following cell infusion:
  • Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) < 45% on a cardiac stress test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram, or other stress test)
  • Similarly, patients who are >= 50 years old with a baseline LVEF < 45% will be excluded
  • Patients with ECG results of any conduction delays (PR interval > 200 ms, corrected QT interval [QTC] > 480 ms), sinus bradycardia (resting heart rate < 50 beats per minute), sinus tachycardia (heart rate > 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > 20 premature ventricular contractions [PVCs] per minute), ventricular tachycardia, third (3rd) degree heart block will be excluded from the study unless cleared by a cardiologist
  • Patients with pulmonary function test abnormalities as evidenced by a forced expiration volume in one second (FEV1)/forced vital capacity (FVC) < 70% of predicted for normality will be excluded
  • Evidence of diverticulitis at baseline, including evidence limited to computed tomography (CT) scan only
  • Received 3 or more prior myelotoxic treatment regimens
  • Bone marrow involvement based on CT or PET scan at screening

Location:

  • UCLA / Jonsson Comprehensive Cancer Center
  • Los Angeles California 90095 United States

View trial on ClinicalTrials.gov


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Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment


Condition: Childhood Cancer, Fertility Disorders

Intervention:

  • Procedure: testicular tissue biopsy

Purpose: Background: Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed. Primary aims - To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment. Secondary aims - To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility - To create a database in order to record clinical and biological follow-up data - To create a research biobank for future research projects Multicentric study: HUG, CHUV, UKBB

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03180918

Sponsor: Gumy-Pause Fabienne

Primary Outcome Measures:

  • Measure: Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
  • Time Frame: 0-20 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of complications related to the testicular biopsy (safety)
  • Time Frame: 0-20 years
  • Safety Issue:
  • Measure: Comparison of biochemical markers
  • Time Frame: 0-20 years
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: January 2015

Eligibility:

  • Age: minimum 3 Months maximum 18 Years
  • Gender: Male

Inclusion Criteria:

  • Prepubertal patients aged 3 months and older
  • Peri and pubertal patients after failure of sperm cryopreservation
  • Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
  • Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue

Exclusion Criteria:

  • Patients under the age of 3 months
  • Refusal of the patient and/or his parents
  • Treatments that are not highly gonadotoxic

Contact:

  • Fabienne Gumy-Pause, Dr

Locations:

  • UKBB
  • Basel Switzerland
  • Geneva University Hospitals
  • Geneva 1211 Switzerland
  • CHUV
  • Lausanne Switzerland

View trial on ClinicalTrials.gov


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Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters


Condition: Hypogonadism, Male

Intervention:

  • Drug: NATESTO® (4.5% nasal testosterone) Nasal Gel

Purpose: Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly.This will be a prospective case study. The investigators will identify men with hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT). Natesto is a relatively new form of testosterone replacement therapy that is delivered intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg testosterone/dose), three times a day (TID) dosing was shown to also increase serum testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone (T) <350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between 6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be excluded.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03203681

Sponsor: University of Miami

Primary Outcome Measures:

  • Measure: Semen analysis
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Clinical laboratory assessment. Testosterone hormone
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Clinical laboratory assessment. Follicle Stimulate Hormone (FSH)
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Clinical laboratory assessment. Luteinizing Hormone (LH)
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Clinical laboratory assessment. Estradiol Hormone
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Sexual Health Inventory in Men (SHIM)
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Quality of life questionnaire
  • Time Frame: 6 months
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: October 27, 2017

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum 55 Years
  • Gender: Male

Inclusion Criteria:

  • Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
  • Male between 18 and 55 years of age, inclusive, with documented onset of hypogonadism prior to age 55.
  • Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
  • Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained at least 1.5 hours apart between 6:00 am and 10:00 am following an appropriate washout of current androgen replacement therapy.
  • Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 weeks following androgen treatment (excluding Testopel). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.
  • Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • History of significant sensitivity or allergy to androgens, castor oil or product excipients.
  • Clinically significant findings in the prestudy examinations including abnormal breast examination requiring follow-up, abnormal ECG.
  • Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptoms Score (I-PSS) > 19 points.
  • Body mass index (BMI) ≥ 30 kg/m2.
  • Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to: 1. Baseline hemoglobin < 11.5 g/dL or > 16 g/dL 2. Hematocrit < 35% or > 54% 3. Serum transaminases > 2.5 times upper limit of normal 4. Serum bilirubin > 2.0 mg/dL 5. Creatinine > 2.0 mg/dL f. Prostate-Specific Antigen (PSA) > 2 ng/mL
  • History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
  • History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
  • History of stroke or myocardial infarction within the past 5 years.
  • History of, or current or suspected, prostate or breast cancer.
  • History of diagnosed, severe, untreated, obstructive sleep apnea.
  • History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
  • Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
  • Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
  • Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
  • Inability to understand and provide written informed consent for the study.
  • Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Natesto.

Contact:

  • Manuel Molina, MD
  • 305-243-4873 Ext. 1176

Location:

  • University of Miami
  • Miami Florida 33136 United States

View trial on ClinicalTrials.gov


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Phase II Study of Avelumab in Multiple Relapsed/Refractory Testicular Germ Cell Cancer.


Condition: Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal, Neoplasms, Testicular Diseases, Gonadal Disorders, Antineoplastic Agents, Molecular Mechanisms of Pharmacological Action

Intervention:

  • Drug: Avelumab

Purpose: This is a proof-of-concept study to define efficacy of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs). Data suggest that PD-L1 is overexpressed in TGCTs, and PD-L1 expression is significantly higher in GCTs in comparison to normal testicular tissue.Patients with low PD-L1 expression had significantly better progression-free survival (hazard ratio [HR] = 0.40, 95% CI (0.16 - 1.01, p = 0.008) and overall survival (HR = 0.43, 95% CI (0.15 - 1.23, p = 0.040) compared to patients with high PD-L1 expression. These data suggest that PD-1/PD-L1 pathway could be a novel therapeutic target in TGCTs and that there is strong rationale to inhibit PD-1/PD-L1 signaling in GCTs.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03403777

Sponsor: National Cancer Institute, Slovakia

Primary Outcome Measures:

  • Measure: To determine the efficacy (as measured by 12-week progression-free survival) of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs).
  • Time Frame: 12-weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: To describe the favorable response rate of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs).
  • Time Frame: 4-weeks
  • Safety Issue:
  • Measure: Progression-free survival (PFS) of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs).
  • Time Frame: 12-months
  • Safety Issue:
  • Measure: Toxic effects of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs).
  • Time Frame: 12-weeks
  • Safety Issue:

Estimated Enrollment: 43

Study Start Date: November 15, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Signed written informed consent
  2. Men aged 18 years or older
  3. ECOG performance status: 0-1
  4. Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
  5. Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
  6. Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy
  7. Primary mediastinal GCTs in first relapse
  8. Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator,
  9. RECIST 1.1 Measurable disease
  10. Adequate hematologic function defined by ANC ≥ 1500/mm3, platelet count ≥ 100 000/mm3 and hemoglobin level ≥ 9g/dl.
  11. Adequate liver function defined by a total bilirubin level ≤ 1.5 ULN, and ALT, AST ≤ 2.5 × ULN . or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
  12. Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance ≥ 30 ml/min. Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)]
  13. At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry,
  14. At least 4 weeks must have elapsed since the last major surgery
  15. Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1,
  16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  17. Highly effective contraception for both male and female subjects if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 30 days after avelumab treatment.

Exclusion Criteria:

  • 1. Patients who do not fit inclusion criteria 2. Other prior malignancy except successfully treated non-melanoma skin cancer 3. No prior PD-1/PD-L1 inhibitor 4. Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy 5. Female patients 6. Patients infected by the Human Immunodeficiency Virus (HIV) 7. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. 8. Other significant diseases: e.g. immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with the study participation, study treatment administration, or may interfere with the interpretation of study results and, which, in judgment of the investigator, would make the patient inappropriate for entry into this study. 9. Hypersensitivity to any compound of the drug 10. Sexually active men not using highly effective birth control if their partners are women of child-bearing potential 11. All subjects with brain metastases, except those meeting the following criteria:
  • Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
  • No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
  • Subjects must be either off steroids or on a stable or decreasing dose of <10mg daily prednisone (or equivalent) 12. Prior organ transplantation, including allogeneic stem cell transplantation 13. Significant acute or chronic infections including, among others: 14. Active infection requiring systemic therapy
  • Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive) 15. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent: 1. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible 2. Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day 3. Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation...) are acceptable 4. steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication). 16. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) 17. Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable 18. Known alcohol or drug abuse 19. All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment 20. Any psychiatric condition that would prohibit the understanding or rendering of informed consent 21. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines

Contact:

  • Daniela Světlovska, PhD
  • +421-2-59378 Ext. 592

Location:

  • National Cancer Institute
  • Bratislava 83310 Slovakia

View trial on ClinicalTrials.gov


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Whole Body MRI With DWI for Monitoring Patients Treated for Testicular Cancer Stage II-III


Condition: Testicular Neoplasm

Intervention:

  • Diagnostic Test: MRI with DWI vs CT

Purpose: Testicular cancer (TC) affects approx. 1% of Danish men and is the most common cancer in men aged 15-35 years. It is the most curable solid cancer type with a 5-year survival rate of 90-95%. Staging and follow-up of these patients involve 5-10 CT scans of each patient, imposing a significant radiation burden: Approx. 3-5 of the 300 Danish patients presenting with TC each year are expected to develop a radiation-induced secondary cancer, half of which are expected to be fatal. MRI is rapidly developing and new WB-MRI can cover large parts of the body in a clinically realistic scan time. With this development, it is within reach to nearly eliminate the radiation burden by substituting the large amount of CT scans with MRI scans in TC. MRI is without any known risk of long-term side effects. Despite this, limited data exist on MRI used in follow-up of TC. At Aarhus University Hospital, we introduced MRI for the follow-up of TC stage I in 2008. We now want to evaluate the results of in this unique cohort of patients and evaluate in a prospective trial if the newest WB-MRI techniques can replace CT in patients with TC stage II-IV. To the best of our knowledge, no study has investigated how much it is possible to reduce the MRI scan time in patients with TC in order to develop a clinically realistic scan time while still maintaining an acceptable uncompromised diagnostic accuracy. The overall aim of this study is to reduce the risk of radiation-induced secondary cancers in patients operated diagnosed with TC by replacing CT as a follow-up imaging method with non-ionizing WB-MRI including DWI. We have these specific aims: - To study the ability of WB-MRI with DWI to replace standard CT in TC stage II-III patients in a prospective non-inferiority study. - To evaluate if it is possible to reduce scan time in the WB-MRI protocols in the TC stage II-III group while maintaining sufficient diagnostic accuracy in order to improve clinical application of the techniques.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03436901

Sponsor: Aarhus University Hospital

Primary Outcome Measures:

  • Measure: MRI vs CT for testicular cancer
  • Time Frame: Aprox. 1 month after treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Optimization of MRI scan duration
  • Time Frame: Aprox. 1 month after treatment
  • Safety Issue:

Estimated Enrollment: 78

Study Start Date: February 19, 2018

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Newly diagnosed TC stage II-III disease or
  • Previously TC stage I disease with new spread of disease during surveillance

Exclusion Criteria:

  • Age < 18 years
  • Claustrophobia or unable to fit inside the bore of the MRI-scanner
  • Foreign metal objects contraindicating a 1.5T MRI including pacemaker

Contact:

  • Solveig KA Larsen, MD
  • +4540461795

Location:

  • Aarhus University Hospital, Dept Radiology
  • Aarhus 8000 Denmark

View trial on ClinicalTrials.gov


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Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial


Condition: Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum, Disease-free Survival, Overal Survival

Intervention:

  • Other: neoadjuvant chemoradiotherapy

Purpose: For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03504449

Sponsor: Beijing Chao Yang Hospital

Primary Outcome Measures:

  • Measure: circumferential resection margin
  • Time Frame: one week after operation
  • Safety Issue:
  • Measure: introperative perforation
  • Time Frame: During the operation
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: local recurrece
  • Time Frame: 3 years after operation
  • Safety Issue:
  • Measure: overal survival
  • Time Frame: 3 years after operation
  • Safety Issue:
  • Measure: disease-free survival
  • Time Frame: 3 years after operation
  • Safety Issue:
  • Measure: complications
  • Time Frame: 30 days after operation
  • Safety Issue:

Estimated Enrollment: 350

Study Start Date: December 1, 2016

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  1. Tumor within 12 cm of the anal verge
  2. T3N1-2 as determined by preoperative MRI examination
  3. negative circumferential resection margin determined by preoperative MRI examination
  4. Absence of distant metastases
  5. Absence of intestinal obstruction

Exclusion Criteria:

  1. With distant metastases
  2. With intestinal obstruction
  3. Pregnancy or lactation
  4. With operation contraindication
  5. With mental disorder

Contact:

  • Jiagang Han, MD
  • +861085231604

Location:

  • Beijing Chaoyang Hospital
  • Beijing Beijing 100020 China

View trial on ClinicalTrials.gov


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A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors


Condition: Germ Cell Tumor, Teratoma, Choriocarcinoma, Germinoma, Mixed Germ Cell Tumor, Yolk Sac Tumor, Childhood Teratoma, Malignant Germ Cell Neoplasm, Extragonadal Seminoma, Non-seminomatous Germ Cell Tumor, Seminoma

Intervention:

  • Drug: paclitaxel
  • Drug: ifosfamide
  • Drug: cisplatin
  • Drug: pegylated G-CSF
  • Drug: G-CSF
  • Drug: carboplatin
  • Drug: etoposide phosphate
  • Procedure: stem cell reinfusion

Purpose: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02375204

Sponsor: Alliance for Clinical Trials in Oncology

Primary Outcome Measures:

  • Measure: overall survival
  • Time Frame: Up to 36 months post-treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: progression free survival
  • Time Frame: Up to 36 months post-treatment
  • Safety Issue:
  • Measure: proportion of patients achieving either a complete response (CR) or partial response
  • Time Frame: Up to 3 months post-registration
  • Safety Issue:
  • Measure: treatment related mortality
  • Time Frame: Up to 30 days post-treatment
  • Safety Issue:
  • Measure: number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Time Frame: Up to 3 months post-registration
  • Safety Issue:
  • Measure: Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval)
  • Time Frame: Up to 3 years post-registration
  • Safety Issue:

Estimated Enrollment: 420

Study Start Date: March 2015

Phase: Phase 3

Eligibility:

  • Age: minimum 14 Years maximum N/A
  • Gender: Male

Eligibility Criteria:

  • (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy).
  • Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy.
  • No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue)
  • No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed.
  • No concurrent treatment with other cytotoxic drugs or targeted therapies.
  • No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy.
  • No previous chemotherapy within 17 days prior to enrollment. A minimum of three weeks after the last day of the start of the previous chemotherapy regimen before the first day of chemotherapy on study protocol.
  • Must have adequate recovery from prior surgery (eg, healed scar, resumption of diet) 4. Age ≥ 14 years (≥ 18 years in Germany) 5. ECOG Performance Status 0 to 2 6. Male gender 7. Required Initial Laboratory Values:
  • Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
  • Platelet Count ≥ 100,000/mm^3
  • Calculated creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 2.0 x upper limits of normal (ULN)
  • AST/ALT ≤ 2.5 x upper limits of normal (ULN) 8. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed. 9. Negative Serology (antibody test) for the following infectious diseases:
  • Human Immunodeficiency Virus (HIV) type 1 and 2
  • Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe)
  • Hepatitis B surface antigen
  • Hepatitis C antibody 10. No late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible. 11. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with high-dose carboplatin or etoposide. 12. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression.

Contact:

  • Darren Feldman, MD
  • 646 422-4491

Locations:

  • UC San Diego Moores Cancer Center
  • La Jolla California 92093 United States
  • Loma Linda University Medical Center
  • Loma Linda California 92354 United States
  • USC / Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • Kaiser Permanente-Oakland
  • Oakland California 94611 United States
  • Stanford Cancer Institute Palo Alto
  • Palo Alto California 94304 United States
  • UCSF Medical Center-Mission Bay
  • San Francisco California 94158 United States
  • University of Florida Health Science Center - Gainesville
  • Gainesville Florida 32610 United States
  • Nicklaus Children's Hospital
  • Miami Florida 33155 United States
  • Johns Hopkins All Children's Hospital
  • Saint Petersburg Florida 33701 United States
  • Emory University Hospital/Winship Cancer Institute
  • Atlanta Georgia 30322 United States
  • Northwestern University
  • Chicago Illinois 60611 United States
  • Rush University Medical Center
  • Chicago Illinois 60612 United States
  • University of Illinois
  • Chicago Illinois 60612 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Cancer Center of Kansas - Wichita
  • Wichita Kansas 67214 United States
  • Via Christi Regional Medical Center
  • Wichita Kansas 67214 United States
  • Dana-Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • University of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States
  • Spectrum Health at Butterworth Campus
  • Grand Rapids Michigan 49503 United States
  • Metro Health Hospital
  • Wyoming Michigan 49519 United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • Minneapolis Minnesota 55404 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • Nebraska Methodist Hospital
  • Omaha Nebraska 68114 United States
  • Memorial Sloan Kettering Basking Ridge
  • Basking Ridge New Jersey 07920 United States
  • Hackensack University Medical Center
  • Hackensack New Jersey 07601 United States
  • Memorial Sloan Kettering Monmouth
  • Middletown New Jersey 07748 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • Memorial Sloan Kettering Commack
  • Commack New York 11725 United States
  • Memorial Sloan Kettering Westchester
  • Harrison New York 10604 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Memorial Sloan Kettering Nassau
  • Uniondale New York 11553 United States
  • UNC Lineberger Comprehensive Cancer Center
  • Chapel Hill North Carolina 27599 United States
  • Carolinas Medical Center/Levine Cancer Institute
  • Charlotte North Carolina 28203 United States
  • Cincinnati Children's Hospital Medical Center
  • Cincinnati Ohio 45229 United States
  • Ohio State University Comprehensive Cancer Center
  • Columbus Ohio 43210 United States
  • University of Oklahoma Health Sciences Center
  • Oklahoma City Oklahoma 73104 United States
  • Children's Hospital of Philadelphia
  • Philadelphia Pennsylvania 19104 United States
  • University of Pennsylvania/Abramson Cancer Center
  • Philadelphia Pennsylvania 19104 United States
  • University of Pittsburgh Cancer Institute (UPCI)
  • Pittsburgh Pennsylvania 15232 United States
  • Rhode Island Hospital
  • Providence Rhode Island 02903 United States
  • Medical University of South Carolina
  • Charleston South Carolina 29425 United States
  • Greenville Health System Cancer Institute-Easley
  • Easley South Carolina 29640 United States
  • Saint Francis Hospital
  • Greenville South Carolina 29601 United States
  • Greenville Health System Cancer Institute-Butternut
  • Greenville South Carolina 29605 United States
  • Greenville Health System Cancer Institute-Faris
  • Greenville South Carolina 29605 United States
  • Greenville Memorial Hospital
  • Greenville South Carolina 29605 United States
  • Saint Francis Cancer Center
  • Greenville South Carolina 29607 United States
  • Greenville Health System Cancer Institute-Eastside
  • Greenville South Carolina 29615 United States
  • Greenville Health System Cancer Institute-Greer
  • Greer South Carolina 29650 United States
  • Greenville Health System Cancer Institute-Seneca
  • Seneca South Carolina 29672 United States
  • Greenville Health System Cancer Institute-Spartanburg
  • Spartanburg South Carolina 29307 United States
  • St. Jude Children's Research Hospital
  • Memphis Tennessee 38105 United States
  • The Children's Hospital at TriStar Centennial
  • Nashville Tennessee 37203 United States
  • Vanderbilt University/Ingram Cancer Center
  • Nashville Tennessee 37232 United States
  • M D Anderson Cancer Center
  • Houston Texas 77030 United States
  • Froedtert and the Medical College of Wisconsin
  • Milwaukee Wisconsin 53226 United States
  • Royal Prince Alfred Hospital
  • Camperdown New South Wales 2050 Australia
  • Princess Alexandra Hospital
  • Woolloongabba Queensland 4102 Australia
  • Box Hill Hospital
  • Box Hill Victoria 3128 Australia
  • Peter MacCallum Cancer Centre
  • Melbourne Victoria 3000 Australia
  • University Hospital Saint Luc
  • Brussels 1200 Belgium
  • Institut Jules Bordet
  • Bruxelles 1000 Belgium
  • Rigshospitalet University Hospital
  • Copenhagen 2100 Denmark
  • Centre Leon Berard
  • Lyon 69373 France
  • Institut Paoli Calmettes
  • Marseille 13273 France
  • Hopital Tenon
  • Paris 75970 France
  • CHRU Strasbourg - Hospital Civil
  • Strasbourg 67091 France
  • Center Claudius Regaud
  • Toulouse 31052 France
  • Gustave Roussy
  • Villejuif 94805 France
  • Technical University Dresden
  • Dresden Saxony 01307 Germany
  • University of Berlin Charite Campus Benjamin Franklin
  • Berlin 12203 Germany
  • University of Dusseldorf
  • Dusseldorf 40225 Germany
  • University of Essen
  • Essen 45122 Germany
  • University Medical Center Hamburg-Eppendorf
  • Hamburg 20246 Germany
  • GK-Mittelrhein Saint Martin's
  • Koblenz 56068 Germany
  • Philipps University Marburg
  • Marburg 35033 Germany
  • Rotkreuzklinikum Munchen
  • Munich 80634 Germany
  • Klinikum Nurnberg Nord
  • Nurnberg 90419 Germany
  • University Hospital Ulm
  • Ulm 89081 Germany
  • Saint James Hospital
  • Dublin 8 Ireland
  • Ospedale di Circolo di Busto Arsizio
  • Busto Arsizio 21052 Italy
  • Istituto Scientifico Romagnolo
  • Meldola 47014 Italy
  • Istituto Nazionale Tumori
  • Milano 20133 Italy
  • San Matteo Hospital
  • Pavia 27100 Italy
  • The Netherlands Cancer Institute
  • Amsterdam 1066 CX Netherlands
  • University Medical Center Groningen
  • Groningen 9700 GZ Netherlands
  • Radboud University Nijmegen Medical Centre
  • Nijmegen 6500 HB Netherlands
  • Hospital De La Santa Creu I Sant Pau
  • Barcelona 08025 Spain
  • Duran i Reynals Hospital-Catalan Institute of Oncology
  • Barcelona 08908 Spain
  • Hospital General Universitario Morales Meseguer
  • Murcia 30008 Spain
  • Inselspital
  • Bern 3010 Switzerland
  • Hopitaux Universitaires de Geneve
  • Geneva 1211 Switzerland
  • University Hospital Zurich
  • Zurich 8091 Switzerland
  • Saint Bartholomew's Hospital
  • London England EC1A 7BE United Kingdom
  • Weston Park Hospital
  • Sheffield England S10 2SJ United Kingdom
  • Southampton General Hospital
  • Southampton England SO16 6YD United Kingdom
  • Saint James's University Hospital
  • West Yorkshire England LS9 7TF United Kingdom
  • Beatson Oncology Center
  • Glasgow Scotland G12 0YN United Kingdom
  • The Royal Marsden NHS Foundation Trust - Sutton
  • Surrey SM2 5PT United Kingdom

View trial on ClinicalTrials.gov


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A Multicenter Phase II Study of Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors


Condition: Germ Cell Tumors, Testis Cancer, Testicular Cancer, Embryonal Carcinoma, Nonseminomatous Germ Cell Tumor

Intervention:

  • Drug: Brentuximab Vedotin

Purpose: This is a Phase II study to evaluate the activity of brentuximab vedotin in relapsed/refractory non-seminomatous germ cell tumors (NSGCT).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02689219

Sponsor: Costantine Albany

Primary Outcome Measures:

  • Measure: Objective response (proportion of patients who achieve either a partial or complete response)
  • Time Frame: Before cycle 3 (i.e., at +43 days)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression free survival
  • Time Frame: From date of initiation of therapy until the time of disease progression or death (which ever comes first) up to 2 years
  • Safety Issue:
  • Measure: Toxicity
  • Time Frame: Every cycle (i.e. at +22 days, +43 days, etc.)
  • Safety Issue:

Estimated Enrollment: 58

Study Start Date: March 9, 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Subject must meet all of the following applicable inclusion criteria to participate in this study: 1. Age ≥ 18 years at the time of informed consent. 2. Patients with histologically or serologically confirmed relapsed/refractory non-seminoma germ cell tumor, (i.e., embryonal carcinoma, choriocarcinoma, or yolk sac tumors) including female GCT and primary mediastinal NSGCT. 3. Patients must have progressed after prior high dose chemotherapy (HDCT) treatment, been deemed not to be a candidate for high dose chemotherapy or refused high-dose chemotherapy, and be considered incurable by other standard therapies including further chemotherapy or surgery. There is no maximum allowable number of previous therapies. "Failure" of prior therapy is defined as: 1. A >25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection. 2. The presence of new tumors which are not amenable to surgical resection. 3. An increase in AFP or beta-hCG (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure). NOTE: Patients with clinically growing "teratoma" (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery. 4. Patients must have evidence of recurrent or metastatic carcinoma by one or more of the following: i) The appearance of metastatic disease by standard imaging techniques ii) The appearance of rising serum tumor marker, AFP or beta-hCG NOTE: If a rising tumor marker is the only evidence of progressive disease, at least 2 consecutive rising values at least one week apart are needed. Patients with only evidence of disease is rising tumor marker AFP and beta-hCG will be provided alternate causes of increased serum levels of these markers are not present, such as cross reaction with luteinizing Hormone (LH) (that can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana or second primary tumor, etc. 5. Patients with primary medistinal non seminomatous germ cell tumor are eligible if they have received first line platinum based chemotherapy and their recurrence is not amenable to surgical resection based on the treating physician expert opinion. 6. Patients with late relapse (>2 years) of non seminomatous germ cell tumors are eligible if they have received first line platinum based chemotherapy and their recurrence is not amenable to surgical resection based on the treating physician expert opinion. 7. Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic. Subjects with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician. 8. Patients with ECOG performance status of 0-2. 9. Adequate organ and marrow function as defined below: 1. Hemoglobin ≥ 8 g/dL 2. Absolute neutrophil count ≥ 1,000/mm3 3. Platelet count ≥ 75,000/mm3 4. Total bilirubin ≤ 1.5 × ULN except patients with documented Gilbert's syndrome (≤ 3 × ULN) 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5 × ULN 6. Calculated creatinine clearance ≥ 30 mL/min as determined by the Cockcroft-Gault equation. 10. Patients who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy for tumor cells before therapy to assess for CD30 status (unless archival tumor tissue from orchiectomy or other previous sample is not obtainable despite efforts to do so and a fresh tumor biopsy is not feasible). 11. Females of childbearing potential must not be pregnant or breast-feeding. Male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through 28 days after the last dose of study drug. Acceptable forms of effective contraception include:
  • Oral, injected or implanted hormonal methods of contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
  • True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.] Pregnancy tests for females of childbearing potential are required; must be serum at screening and the post treatment safety assessment visit. A positive urine pregnancy test must be confirmed by a serum pregnancy test and a pelvic US since some NSGCT may secrete beta-hCG and cause a false positive pregnancy. A pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so. 12. Potential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures.

Exclusion Criteria:

  1. Subjects meeting any of the criteria below may not participate in the study:
  2. Patients with pure seminoma.
  3. Patients with pure teratoma.
  4. Chemotherapy within 2 weeks of initiating study treatment. There is no maximum allowable number of previous therapies.
  5. Major surgery within 3 weeks of starting study treatment. There is no minimum time requirement for minor procedures such as biopsy or vascular access placement.
  6. Radiation within 2 weeks of starting study treatment.
  7. ≥ Grade 3 neuropathy at the time of enrollment.
  8. Pregnancy or breast-feeding.
  9. Previous treatment with any anti-CD30 directed therapy.

Contact:

  • Yvonne LaFary, RN
  • 317-278-5613

Locations:

  • USC/Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • Indiana University Health Hospital
  • Indianapolis Indiana 46202 United States
  • Indiana University Health Melvin and Bren Simon Cancer Center
  • Indianapolis Indiana 46202 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Intermountain Precision Genomics Cancer Research Clinic
  • Murray Utah 84107 United States

View trial on ClinicalTrials.gov


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A Single-arm, Phase II Study of Durvalumab (MEDI4736) and Tremelimumab for Relapsed/Refractory Germ Cell Tumors


Condition: Germ Cell Tumor, Nonseminomatous Germ Cell Tumor, Seminoma, Germinomatous Germ Cell Tumor, Dysgerminoma, Pineal Germ Cell Tumor

Intervention:

  • Drug: Durvalumab
  • Drug: Tremelimumab

Purpose: The purpose of this study is to test the safety and effectiveness of durvalumab with tremelimumab in patients with relapsed or refractory germ cell tumors.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03158064

Sponsor: Memorial Sloan Kettering Cancer Center

Primary Outcome Measures:

  • Measure: Best confirmed overall response
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 29

Study Start Date: May 15, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age ≥ 18 years at time of informed consent
  • Body weight > 30 kg
  • Histologically confirmed diagnosis of GCT (nonseminoma or seminoma in men; non-dysgerminomas, dysgerminomas, or germinomas in women or patients with pineal gland GCT) at MSKCC of any primary site (includes female GCT and intracranial GCT).
  • Evidence of measurable disease either by RECIST 1.1 or elevation of serum tumor markers (AFP > 15 ng/mL or HCG >2.2 mIU/ml).
  • Patients must have progressed after at least one prior systemic therapy for GCT and meet one of the following criteria: a. Patients with evidence of progressive or recurrent GCT after progression prior high dose chemotherapy (HDCT) treatment, defined as meeting at least on of the following criteria: i. Tumor biopsy of new or growing or unresectable lesions demonstrating viable GCT. In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for this study. ii. Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease. iii. Development of new or enlarging lesions in the the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to rise. b. Patients deemed not to be a candidate for or benefit from potentially curative HDCT or other curative treatment options defined as follows: i. Patients with inadequate renal function for HDCT. ii. Patients who have had 3 or more lines of prior chemotherapy as this patient population has historically not benefitted from HDCT. iii. Patients with late relapse (relapse > 2 years after last therapy) as this patient population has historically not benefitted from HDCT. iv. Patient with inadequate stem cell collection to move forward with HDCT. v. Patients with significant medical or psychosocial comorbidities that are felt to be a contraindication to HDCT by the treating investigator. NOTE: There is no maximum number of prior treatments allowed "Progression" after prior therapy is defined as any one of the following: NOTE: Patients with clinically growing "teratoma" (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery. In patients with rising tumor markers as their only evidence of disease progression where AFP is <30 or HCG is <15, alternate causes of increased levels of these markers should be ruled out. (e.g., hypogonadism by testosterone suppression of LH, hepatitis, use of marijuana).
  • Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic. Subjects with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate normal organ and marrow function as defined below:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (> 1000 per mm3)
  • Platelet count ≥ 100 x 109/L (>100,000 per mm3)
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (≤ 3 x institutional ULN in patient's with Gilbert's syndrome)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN
  • Calculated creatinine clearance >30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply.
  • Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women >/= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • A positive serum pregnancy test must be confirmed by a pelvic US since some NSGCT may secrete beta-hCG and cause a false positive pregnancy. A pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so.
  • Female patients of reproductive potential, defined as not surgical sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal (see above for definition) and non-sterilized males who are sexually active with a female partner of reproductive potential must be willing to adhere to the following restrictions:
  • Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening until 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. It is strongly recommended that non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period Not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice.
  • Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Not engaging in sexual activity is an acceptable practice. Male patients should refrain from sperm donation throughout this period. It is strongly recommended that female partners (of childbearing potential) of male patients to also use a highly effective method of contraception throughout this period.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Previous enrolment in the present study
  • Participation in another clinical study with an investigational product during the last 14 days
  • Mean QT interval corrected for heart rate (QTc) ≥ 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction
  • Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA-4, including tremelimumab
  • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 14 days prior to the first dose of study drug
  • Major surgery within 28 days of starting study treatment. There is no minimum time requirement for minor procedures such as biopsy or vascular access placement.
  • Radiation within 14 days of starting study treatment
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., alopecia, hearing loss, peripheral neuropathy).
  • History of pulmonary fibrosis by imaging or biopsy (including secondary to bleomycin), pneumonitis (including drug induced) requiring steroids ≥ 3 weeks, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan with associated symptoms.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc)). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician
  • Patients with diverticulosis
  • Patients with celiac disease controlled by diet alone
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • History of hypersensitivity to durvalumab, tremelimumab or any excipient
  • Uncontrolled intercurrent illness including, but not limited to, on-going or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Known history of previous clinical diagnosis of tuberculosis
  • History of leptomeningeal carcinomatosis
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab. Inactivated vaccines, such as the injectable influenza vaccine, are permitted.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  • Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score 6, and prostate-specific antigen (PSA) 10 mg/mL, etc).
  • Patients should agree to not donate blood while participating in this study or for at least 90 days following the last infusion of durvalumab or tremelimumab
  • Female patients who are pregnant or breastfeeding

Contact:

  • Samuel Funt, MD
  • 646-422-4558

Locations:

  • Memoral Sloan Kettering Basking Ridge
  • Basking Ridge New Jersey 07920 United States
  • Memorial Sloan Kettering Monmouth
  • Middletown New Jersey 07748 United States
  • Memorial Sloan Kettering Bergen
  • Montvale New Jersey 07645 United States
  • Memorial Sloan Kettering Commack
  • Commack New York 11725 United States
  • Memoral Sloan Kettering Westchester
  • Harrison New York 10604 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Memorial Sloan Kettering Rockville
  • Rockville Centre New York 11570 United States

View trial on ClinicalTrials.gov


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Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer


Condition: Adult Solid Tumor, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Adult Central Nervous System Germ Cell Tumor, Adult Teratoma, Benign Teratoma, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, Familial Testicular Germ Cell Tumor, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Male Breast Cancer, Ovarian Immature Teratoma, Ovarian Mature Teratoma, Ovarian Monodermal and Highly Specialized Teratoma, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Extragonadal Germ Cell Tumor, Recurrent Extragonadal Non-seminomatous Germ Cell Tumor, Recurrent Extragonadal Seminoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Melanoma, Recurrent Ovarian Germ Cell Tumor, Recurrent Rectal Cancer, Stage III Extragonadal Non-seminomatous Germ Cell Tumor, Stage III Extragonadal Seminoma, Stage III Malignant Testicular Germ Cell Tumor, Stage III Ovarian Germ Cell Tumor, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Extragonadal Non-seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Melanoma, Stage IV Ovarian Germ Cell Tumor, Stage IV Rectal Cancer, Testicular Immature Teratoma, Testicular Mature Teratoma

Intervention:

  • Drug: PD-0332991
  • Other: pharmacological study

Purpose: RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01037790

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Primary Outcome Measures:

  • Measure: Response rates
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Safety and tolerability
  • Time Frame: 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Pharmacodynamic effects on tumor and non-tumor tissue
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Relationship between selected biomarkers, pharmacokinetics, and/or efficacy and safety outcomes
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Population pharmacokinetic for PD 0332991 and correlation with efficacy outcomes
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 205

Study Start Date: October 2009

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

    Disease Characteristics:

    • All Subjects: All subjects treated under this protocol will have histologically documented cancer of one of the following types: A. Metastatic breast cancer (7 triple negative, 23 ER+ after the first 15 patients are enrolled on the non-CCND1cohort; in addition 10 HER2+ for combination trastuzumab and PD0332991 therapy) up to 55 total enrollment slots B. Metastatic colorectal cancer that harbors the Kras or BRAF mutation (15-30 enrollment slots) C. Advanced or metastatic esophageal and/or gastric cancer (15-30 enrollment slots) D. Cisplatin-refractory, unresectable germ cell tumors (15-30 enrollment slots) E. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint. (15-30 enrollment slots)
    • Biopsy Requirements: For Subjects with accessible disease amenable to biopsy: A biopsy will be obtained pre-treatment and in during cycle 1 (while patient is receiving drug) for molecular markers of the cell cycle, and its inhibition.
    • Subjects will be > 18 years old
    • The subject has disease that is assessable by tumor marker, physical, or radiologic means.
    • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • The subject has adequate organ function, defined as follows A. Bilirubin ≤ 1.5 x the upper limit of normal (ULN) B. Serum creatinine ≤ 1.5 x UNL or calculated creatinine clearance ≥ 60 mL/min, and C. For subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN D. For subjects with liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase ≤ 5 x ULN
    • All tumors must test positive for Rb expression except: A. ER positive metastatic breast tumors (data now shows all to be Rb positive.) B. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
    • The subject has adequate marrow function, defined as follows: A. Absolute neutrophil count (ANC) >1500/mm3 B. Platelets >100,000/mm3, and C. Hemoglobin > 9 g/dL
    • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
    • Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of protocol drug(s).
    • Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months.
    • However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression.

    Exclusion Criteria:

    • The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of PD 0332991. . Patients with HER2-overexpressing tumors may receive trastuzumab up to the date of starting therapy, and may continue to receive trastuzumab while receiving PD0332991.
    • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
    • The subject has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade ≤ 1), with the exception of neurotoxicity and alopecia.
    • The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease unless the subject has a teratoma in which case s/he may be eligible if all other

    Eligibility Criteria:

    • are met
    • The subject has uncontrolled intercurrent illness including, but not limited to: 1. ongoing or active infection 2. diabetes mellitus 3. hypertension 4. symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months
    • The subject has a baseline corrected QT interval (QTc) > 470 ms.
    • The subject is pregnant or breastfeeding.
    • The subject is known to be positive for the human immunodeficiency virus (HIV). Note: baseline HIV screening is not required
    • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

    Contact:

    • Peter O Dwyer, MD
    • 855-216-0098

    Location:

    • Abramson Cancer Center of The University of Pennsylvania
    • Philadelphia Pennsylvania 19104 United States

    View trial on ClinicalTrials.gov


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