Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer

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)