Testicular Cancer

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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 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, defined as meeting all of the following criteria:
  • Patients with 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.
  • 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

Location:

  • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
  • Chapel Hill North Carolina 27599 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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