Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
Recurrent Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7

About this trial
This is an interventional treatment trial for Recurrent Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed prostate cancer Metastatic disease Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria: Patients with measurable disease must have an increase of at least 20% in the sum of the longest diameter of target lesions OR the appearance of 1 or more new lesions Patients with nonmeasurable disease must have a positive bone scan and a prostate-specific antigen (PSA) level of at least 5 ng/mL, which has risen on at least 2 successive occasions at least 2 weeks apart* At least 1 PSA level must be obtained at least 4 weeks after flutamide (6 weeks after bicalutamide or nilutamide) Testosterone no greater than 50 ng/dL Patients with no prior orchiectomy must continue luteinizing hormone-releasing hormone agonist therapy No history or radiologic evidence of CNS metastases Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count greater than 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No significant cardiovascular disease No New York Heart Association class III or IV congestive heart failure No active angina pectoris No myocardial infarction within the past 6 months Not pregnant or nursing Fertile patients must use effective contraception prior to, during, and for 3 months after study participation No history of autoimmune disease including, but not limited to, any of the following: Autoimmune hemolytic anemia Ulcerative and hemorrhagic colitis Endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism of immune etiology, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency) Sarcoid granuloma Myasthenia gravis Polymyositis Guillain-Barre syndrome Systemic lupus erythematosus Rheumatoid arthritis Inflammatory bowel disease No other medical or psychiatric illness that would preclude study participation or giving informed consent No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission No prior immunotherapy (e.g., vaccines or investigational) No other concurrent colony-stimulating factors No prior chemotherapy No concurrent chemotherapy See Disease Characteristics At least 4 weeks since prior systemic corticosteroids At least 4 weeks since other prior hormonal therapy, including megestrol and finasteride No concurrent systemic steroid therapy except inhaled or topical steroids No other concurrent hormonal therapy Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed At least 4 weeks since prior radiotherapy and recovered More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 and samarium Sm 153 lexidronam pentasodium) Prior irradiation of a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed No concurrent palliative radiotherapy See Disease Characteristics At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto)
Sites / Locations
- UCSF Medical Center-Mount Zion
Arms of the Study
Arm 1
Experimental
Treatment (monoclonal antibody, colony-stimulating factors)
Patients receive ipilimumab IV over 90 minutes on day 1 and sargramostim (GM-CSF) SC on days 1-14. Treatment repeats every 28 days for 4-6 courses. GM-CSF continues beyond 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ipilimumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Some patients undergo blood sample collection periodically for laboratory and pharmacokinetic studies. Samples are analyzed for human anti-human antibodies, IgG antibodies to ipilimumab semi-quantitative ELISA assay, and plasma concentrations of ipilimumab via quantitative ELISA assay.