CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

• 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/uL
• Bilirubin = 10 g/dL
• Platelets >= 100,000/mcL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = = 60 mL/min by the Cockcroft-Gault equation
• Testosterone = = 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, radium 223 dichloride) must be completed >= 8 weeks prior to enrollment
• Patients must agree to use 2 methods of adequate contraception for the duration of study participation, and for four months after discontinuing therapy
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed
• 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
• 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 virus (HBV) infection is not an exclusion criterion
• 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
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illne