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 < 1.5 x upper limit of normal (ULN)
Hemoglobin >= 10 g/dL
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 or s/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, 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) 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
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 of respiratory dysfunction)