Penile Cancer

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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Intervention:

  • Drug: Chemotherapy TIP

Purpose: Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival are influenced by metastatic lymph node involvement. Its frequency in France is estimated at less than 1% of human cancers. This spread follows a sequential process via the superficial and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic dissemination. The management of inguinal areas is the cornerstone of penile cancer. It is curative in about 80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on average 85% for pN0 patients and 40% for pN + patients. For pN + patients, 5-years overall survival was 70 to 80% for pN1 (only 1 lymph node invasion), and 30 to 40% for pN2 and 0 to 10% for pN3. The risk of local recurrence is 5-10% for pN0 and 20-30% for pN + after local treatment by lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months. Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN +. Its indication depends on clinical examination (presence or absence of lymph nodes palpated) and the risk of nodal disease (≥ pT1bG2). Currently, a fine needle biopsy is the best clinical diagnosis method because it is a simple, low risk and possible in consultation. When the result is positive, it allows an early dissection. Single or double fine needle biopsy will be used in cN + patients. For patients at risk of lymp nodes involvement (cN0 and ≥ pT1B or G2), the sentinel node diagnosis may be followed by modified or bilateral lymphadenectomy. Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in patients with metastatic lymph node involvement. Therefore it seems important to develop a multimodal approach in the management of these patients in order to increase the response rate to treatment and survival. From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide and cisplatin) appears to have an efficacy / toxicity acceptable. The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant treatment in patients with high risk of lymph nodes involvement (cN0 and ≥ pT1B or G2), and with inguinal mobile palpated lymph nodes (cN +) respectively, after lymph nodes involvement proven (pN +).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Primary Outcome Measures:

  • Measure: survival without locoregional lymph node recurrence
  • Time Frame: 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Complete response rate for patients in neoadjuvant chemotherapy
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Survival without locoregional lymph node recurrence
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Survival without metastasis
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Specific survival
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Toxicity
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Quality of life
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 37

Study Start Date: April 2016

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 G/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. FEVG >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

Contact:

  • Sandra PELISSIER
  • +33(0)144235568

Locations:

  • ICO-Paul Papin
  • Angers 49055 France
  • Chr Besancon
  • Besançon 25000 France
  • Hôpital SAINT ANDRE
  • Bordeaux 33075 France
  • Centre FRANCOIS BACLESSE
  • Caen 14076 France
  • Chru Gabriel Montpied
  • Clermont Ferrand 63000 France
  • Ch de Limoges
  • Limoges 87042 France
  • Centre Leon Berard
  • Lyon 69008 France
  • Chu Lyon Sud
  • Lyon 69310 France
  • Institut Paoli-Calmettes
  • Marseille 13273 France
  • Institut de Cancerologie de Lorraine
  • Nancy 54519 France
  • Clinique Urologique- Chu Hotel Dieu
  • Nantes 44093 France
  • Institut de Cancerologie Du Gard - Centre Oncogard
  • Nîmes 300029 France
  • Hopital Saint Louis
  • Paris 75010 France
  • Chu de Rouen
  • Rouen 76031 France
  • ICO-René Gauducheau
  • saint Herblain 44805 France
  • Hopitaux Universitaires de Strasbourg
  • Strasbourg 67091 France
  • Institut Claudius Regaud
  • Toulouse 31059 France

View trial on ClinicalTrials.gov


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Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy


Condition: Penile Squamous Cell Carcinoma

Intervention:

  • Drug: Pembrolizumab

Purpose: Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in less developed countries. PSCC is a highly aggressive malignancy characterized by early spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will serve as the investigational agent for this penile cancer study.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02837042

Sponsor: University of Alabama at Birmingham

Primary Outcome Measures:

  • Measure: Objective tumor response rate
  • Time Frame: Baseline up to two years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Duration of response and stable disease
  • Time Frame: From the first treatment up to two years
  • Safety Issue:
  • Measure: Progression-free survival
  • Time Frame: Baseline up to two years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
  • Safety Issue:
  • Measure: Number of adverse events
  • Time Frame: Baseline up to two years
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: October 2016

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Locally advanced unresectable or metastatic stage 4 (i.e. T4 or N3 or M1) PSCC 2. Radiologic evidence for progressive disease after ≥1 prior chemotherapy regimen 3. Be at least 18 years of age on day of signing informed consent. 4. Have measurable disease based on RECIST 1.1. 5. Have a performance status of 0-2 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale. 6. Demonstrate adequate organ function with all screening labs being performed within 14 days of treatment initiation.
  • Absolute neutrophil count (ANC) ≥1,500 /mcL
  • Platelets ≥100,000/mcL
  • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
  • Serum creatinine ≤1.5 X upper limit of normal (ULN); alternately measured or calculated creatinine clearance ≥30 mL/min with creatinine levels >1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
  • Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN or ≤ 5 X ULN for subjects with liver metastases
  • Albumin >2.5 mg/dL
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 7. Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy 8. Formalin-fixed paraffin embedded (FFPE) tumor tissue from previous biopsy is requested, but not mandatory. 9. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

  • 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has a known history of active TB (Bacillus Tuberculosis) 4. Hypersensitivity to Pembrolizumab or any of its excipients. 5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. Has known history of, or any evidence of active, non-infectious pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 14. Is pregnant expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 18. Has known active Tuberculosis infection. 19. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Contact:

  • Lisle Nabell, MD
  • 205-934-3061

Locations:

  • University of Alabama at Birmingham
  • Birmingham Alabama 35294 United States
  • University of Southern California
  • Los Angeles California 90033 United States
  • Winship Cancer Institute at Emory University
  • Atlanta Georgia 30322 United States

View trial on ClinicalTrials.gov


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A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy


Condition: Penile Squamous Cell Carcinoma (PSCC)

Intervention:

  • Drug: Gilotrif

Purpose: Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02541903

Sponsor: University of Alabama at Birmingham

Primary Outcome Measures:

  • Measure: Progression free survival
  • Time Frame: 6 months following study treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Response rate
  • Time Frame: Baseline up to 18 months
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Baseline to death (assessed up to 30 months).
  • Safety Issue:
  • Measure: Toxicities
  • Time Frame: Baseline up to 18 months
  • Safety Issue:

Estimated Enrollment: 29

Study Start Date: October 2015

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed PSCC. 2. Patients with metastatic or locally advanced unresectable PSCC. 3. Progressive disease after ≥1 prior chemotherapy regimens. 4. Measurable disease by RECIST 1.1 criteria. 5. Prior regimen within 6 months 6. ECOG performance status 0-2. 7. Adequate organ function, defined as all of the following:
  • Absolute neutrophil count (ANC) >1500 /mm3. Platelet count >100,000/ mm3.
  • Estimated creatinine clearance ≥ 45ml/min.
  • Total Bilirubin <1.5 times upper limit of institutional normal; Aspartate amino transferase (AST) or alanine amino transferase (ALT) <2.5 times the upper limit of institutional normal (ULN).
  • Hemoglobin ≥8.5 g/dl. 8. Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE version 4.03 grade <1, in the opinion of the Treating Physician. 9. Ability to understand and willingness to sign a written informed consent. Age ≥18 years or age of majority at the participating site, whichever is greater. 10. Availability of 20 archival formalin-fixed paraffin embedded tumor tissue slides.

Exclusion Criteria:

  1. Patients will have recovered from toxicities from prior systemic anticancer treatment or local therapies.
  2. Prior EGFR inhibitors.
  3. Major surgery within 4 weeks or minor surgery within 2 weeks before registration or scheduled for surgery during the projected course of the study. Wounds will be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of vascular access device is not considered major or minor surgery in this regard.
  4. Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least 3 weeks prior to enrollment. If the irradiated area is the only site of disease, there will be progressive disease.
  5. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to registration.
  6. Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
  7. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
  8. Requiring treatment with any of the prohibited concomitant medications listed in the protocol that cannot be stopped for the duration of trial participation.
  9. Known pre-existing interstitial lung disease.
  10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption).
  11. Active hepatitis B infection (defined as presence of Hep BsAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
  12. Meningeal carcinomatosis.
  13. Patients with active brain or subdural metastases are not eligible, unless they have completed local (radiation) therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases will be stable for at least 4 weeks before starting study treatment.
  14. Any active or uncontrolled infection.

Contact:

  • Pam Dixon, BSN, OCN
  • 205-975-5387

Locations:

  • University of Alabama at Birmingham
  • Birmingham Alabama 35294 United States
  • University of Southern California
  • Los Angeles California 90033 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)


Condition: Squamous Cell Carcinoma of the Penis, Usual Type

Intervention:

  • Procedure: ILND - Inguinal Lymph Node Dissection
  • Drug: Paclitaxel
  • Drug: Ifosfamide
  • Drug: Cisplatin
  • Radiation: Intensity modulated radiation treatment (IMRT)
  • Procedure: Prophylactic PLND - pelvic lymph node dissection

Purpose: This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02305654

Sponsor: Institute of Cancer Research, United Kingdom

Primary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Disease specific survival time
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Number of patients experience a grade 3 or 4 toxicity
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Disease-free survival time
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Occurrence of surgical complication
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Is it possible to achieve pathological nodal assessment after chemotherapy
  • Time Frame: 12 weeks
  • Safety Issue:
  • Measure: Quality of life
  • Time Frame: Baseline, 3, 6, 9, 12, 18, 24 and 36 months
  • Safety Issue:
  • Measure: Occurrence of Pathological complete remission
  • Time Frame: Time to complete remission after randomisation
  • Safety Issue:
  • Measure: Operability
  • Time Frame: 2-6 weeks
  • Safety Issue:
  • Measure: Occurrence of Lower limb/scrotal oedema
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: On-schedule delivery of neoadjuvant therapy
  • Time Frame: After randomisation up to 12 weeks
  • Safety Issue:

Estimated Enrollment: 400

Study Start Date: May 12, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • 1. Written informed consent 2. Measurable disease as determined by RECIST (version 1.1) criteria; 3. Histologically-proven squamous cell carcinoma of the penis, 4. Stage:
  • any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
  • any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
  • any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 5. Performance Status ECOG 0, 1 or 2.

Exclusion Criteria:

  1. Pure verrucous carcinoma of the penis,
  2. Nonsquamous malignancy of the penis,
  3. Squamous carcinoma of the urethra,
  4. Stage M1,
  5. Previous chemotherapy or chemoradiotherapy,
  6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.

Contact:

  • UK - InPACT Senior Trial Manager
  • 02087224261

Locations:

  • Los Angeles County-USC Medical Center
  • Los Angeles California 90033 United States
  • USC / Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • Moffitt Cancer Center
  • Tampa Florida 33612 United States
  • Grady Health System
  • Atlanta Georgia 30303 United States
  • Emory University Hospital/Winship Cancer Institute
  • Atlanta Georgia 30322 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 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
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111 United States
  • University of Texas M.D. Anderson Cancer Center
  • Houston Texas 77030 United States
  • Velindre NHS Trust
  • Cardiff CF14 2TL United Kingdom
  • University Hospitals of Leicester NHS Trust
  • Leicester LE1 5WW United Kingdom
  • The Royal Marsden NHS Foundation Trust
  • London SM2 5PT United Kingdom
  • St George's Hospital NHS Foundation Trust
  • London SW17 0QT United Kingdom
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Norwich NR4 7UY United Kingdom
  • Swansea Bay University Health Board
  • Swansea SA6 6NL United Kingdom

View trial on ClinicalTrials.gov


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HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers


Condition: Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma, Human Papillomavirus Positive Anal Carcinoma, Human Papillomavirus Positive Vulvar Carcinoma, Human Papillomavirus Positive Penile Carcinoma

Intervention:

  • Genetic: HPV Specific T Cells
  • Drug: Cytoxan
  • Drug: Fludarabine
  • Biological: Nivolumab

Purpose: Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers. If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02379520

Sponsor: Baylor College of Medicine

Primary Outcome Measures:

  • Measure: Number of patients with dose limiting toxicity (DLT)
  • Time Frame: 6 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall response rate
  • Time Frame: 6 weeks
  • Safety Issue:

Estimated Enrollment: 32

Study Start Date: September 2015

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • PROCUREMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is:
  • recurrent or persistent after standard therapy
  • OR patient is unable to receive standard therapy 3. Karnofsky score ≥ 50% 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent TREATMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is:
  • recurrent or persistent after standard therapy
  • OR patient is unable to receive standard therapy 3. Life expectancy ≥ 6 weeks. 4. Age ≥ 18 years. 5. Karnofsky score ≥ 50% 6. Bilirubin < 3 × upper limit of normal (ULN), AST < 5 × ULN, Hgb ≥ 7.0 g/dL 7. Pulse oximetry of > 90% on room air. 8. GFR > 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent 9. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent 10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.

Exclusion Criteria:

  1. PROCUREMENT
  2. Known HIV positivity. TREATMENT
  3. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.
  4. Severe intercurrent infection.
  5. Pregnancy or lactation.

Contact:

  • Carlos Ramos, MD
  • 832-824-4817

Location:

  • Houston Methodist Hospital
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors


Condition: Various Advanced Cancer

Intervention:

  • Drug: Nivolumab
  • Drug: Ipilimumab
  • Drug: Relatlimab
  • Drug: Daratumumab

Purpose: The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: - Anal canal cancer-No longer enrolling this tumor type - Cervical cancer - Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type - Merkel Cell Cancer - Penile cancer-No longer enrolling this tumor type - Vaginal and vulvar cancer-No longer enrolling this tumor type - Nasopharyngeal Cancer - No longer enrolling this tumor type - Head and Neck Cancer - No longer enrolling this tumor type

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02488759

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: The safety and tolerability will be measured by the incidence of drug-related adverse events (AEs) and serious adverse events (SAEs)
  • Time Frame: 6 months after the last patient receives their first dose
  • Safety Issue:
  • Measure: Objective response rate
  • Time Frame: 6 months after the last patient receives their first dose
  • Safety Issue:
  • Measure: Rate of surgery delay
  • Time Frame: 6 months after the last patient receives their first dose
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free survival
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Duration of response
  • Time Frame: Approximately 3 years
  • Safety Issue:

Estimated Enrollment: 1100

Study Start Date: October 8, 2015

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types): 1. Merkel Cell Carcinoma 2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type) 3. Nasopharyngeal Carcinoma 4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva 5. Squamous cell carcinoma of the Head and Neck 6. Squamous cell carcinoma of the anal canal and penis 7. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort
  • Measurable disease by CT or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
  • Men and women of age 18 or older

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Patients with hepatitis
  • Patients with HIV
  • Pregnant or breastfeeding women

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

Locations:

  • H. Lee Moffitt Cancer Center
  • Tampa Florida 33612-9497 United States
  • Winship Cancer Institute
  • Atlanta Georgia 30322 United States
  • Local Institution
  • New Orleans Louisiana 70121 United States
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Lutherville Maryland 21093 United States
  • Dana-Farber Cancer Institute
  • Boston Massachusetts 02114 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Beth Israel Desc. Med Ctr
  • Boston Massachusetts 02215 United States
  • University Of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States
  • Memorial Sloan-Kettering Cancer Center-Breast Center
  • New York New York 10065 United States
  • Levine Cancer Institute
  • Charlotte North Carolina 28204 United States
  • Stephenson Cancer Center
  • Oklahoma City Oklahoma 73104 United States
  • Providence Portland Medical Center
  • Portland Oregon 97213 United States
  • UPMC Eye and Ear Institute
  • Pittsburgh Pennsylvania 15232 United States
  • Sanford Clinic Clinical Research
  • Sioux Falls South Dakota 57104-4707 United States
  • Seattle Cancer Care Alliance
  • Seattle Washington 98109 United States
  • Local Institution
  • Capital Federal Buenos Aires 1426 Argentina
  • Local Institution
  • Brussels 1000 Belgium
  • Local Institution
  • Brussels 1090 Belgium
  • Local Institution
  • Bruxelles 1200 Belgium
  • Local Institution
  • Marseille Cedex 9 13273 France
  • Local Institution
  • Paris 75475 France
  • Institut Claudius Regaud
  • Toulouse Cedex 9 31059 France
  • Institut Gustave Roussy
  • Vlllejuif 94800 France
  • Local Institution
  • Essen 45147 Germany
  • Local Institution
  • Heidelberg 69120 Germany
  • Local Institution
  • Heilbronn 74078 Germany
  • Local Institution
  • Wuerzburg 97080 Germany
  • Local Institution
  • Kashiwa-shi Chiba 2778577 Japan
  • Local Institution
  • Chuo-ku Tokyo 1040045 Japan
  • Local Institution
  • Koto-ku Tokyo 135-8550 Japan
  • Local Institution
  • Seoul 110-774 Korea, Republic of
  • COI Centro Oncologico Internacional S.A.P.I. de C.V.
  • Ciudad de Mexico Distrito Federal 04700 Mexico
  • Local Institution
  • Oaxaca de Juarez Oaxaca 68040 Mexico
  • Centro de Atencion e Investigacion Clinica en Oncologia SCP
  • Merida Yucatan 97138 Mexico
  • Local Institution
  • Amsterdam 1066 CX Netherlands
  • Local Institution
  • Utrecht 3584 CX Netherlands
  • Local Institution
  • Craiova 200347 Romania
  • H. Univ. Vall dHebron
  • Barcelona 08035 Spain
  • Hospital Madrid Norte Sanchinarro
  • Madrid 28050 Spain
  • Clinica Universidad de Navarra
  • Navarra 31008 Spain
  • Local Institution
  • Tainan 70403 Taiwan
  • Local Institution
  • Taipei 10002 Taiwan
  • Local Institution
  • Glasgow Lanarkshire G12 OYN United Kingdom
  • Local Institution
  • Birmingham WEST Midlands B15 2TH United Kingdom
  • Local Institution
  • London W1T 7HA United Kingdom

View trial on ClinicalTrials.gov


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