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Prostate Cancer Clinical Trials

Biological Therapy w/wo Vaccine Therapy for Metastatic Hormone-Resistant Prostate Cancer (8037A)
A Phase 2 Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) after Completion of Standard FDA Approved therapy with Sipuleucel-T (Provenge®) for Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration-resistant Prostate Cancer (mCRPC)
Status Conditions Phase Study ID
Recruiting Prostate Cancer Phase II 8037A
NCT01881867
Summary

This randomized phase II trial studies how well biological therapy with or without vaccine therapy works in treating patients with metastatic hormone-resistant prostate cancer. Biological therapies may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether biological therapy is more effective with or without vaccine therapy in treating prostate cancer.


Investigator
Evan Yu, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
  • Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of planned CYT107 study drug treatment
  • Assessable disease with a positive bone scan and/or measurable disease on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) of the abdomen and pelvis
  • Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapy
  • No ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at least 30 days
  • Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. Saw Palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatment
  • Absolute neutrophil count (ANC) >= 1500/µL
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • Hemoglobin >= 10 g/dL
  • PSA >= 2 ng/mL
  • Platelets >= 100,000/mcL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation
  • Testosterone =< 50 ng/dL (documented at any time while on LHRH agonist or antagonists odds ratios [ors]/orchiopexy [p] orchiectomy)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Karnofsky performance status of >= 80%
  • Life expectancy of at least 6 months
  • Prior local radiation therapy must be completed at least 30 days prior to enrollment and the patient must have recovered from all toxicity
  • Prior "systemic" radiopharmaceuticals (strontium, samarium) must be completed >= 8 weeks prior to enrollment
  • Patients must agree to use adequate contraception (barrier method for males) for the duration of study participation, and for four months after discontinuing therapy, because of the unknown potential risk to a gamete and/or developing embryo from this investigational therapy
  • Ability to understand and the willingness to sign a written informed consent document
Exclusions (conditions that would prevent participation in this study)
  • Prior chemotherapy for prostate cancer, with the exception of neoadjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system
  • Prior investigational immunotherapy
  • Prostate cancer pain requiring regularly scheduled narcotics
  • Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
  • Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable); systemic corticosteroids must be discontinued for at least 30 days prior to first CYT107 injection
  • Known central nervous system metastases
  • No documented cirrhosis or documented acute hepatitis; Note: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B (HBV) infection is not an exclusion criterion
  • No history of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less
  • Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves
  • Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
  • Concurrent or prior malignancy except for the following:

    • Adequately treated basal or squamous cell skin cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease-free for 5 years
  • Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder; HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interaction with CYT107; other trials are examining the effect of CYT107 in patients with HIV infection
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of CYT107 hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
  • Prior treatment with anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) or experimental check point inhibitor such as anti-programmed-death (PD)1
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107
  • Patients who have received prior immunosuppressive therapy within 30 days prior to enrollment
  • Active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)
  • Patients who have received hepatotoxic drugs less than 7 days prior to enrollment
  • Patients who have received prior biologic agents less than 30 days prior to enrollment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who have a history of any hematopoietic malignancy
  • History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume [FEV] > 60% of predicted for height and age required in patients with prolonged smoking history or symptoms or respiratory dysfunction)
Last Updated
December 04, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.