Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the prostate
• * Biochemically relapsed prostate cancer
• Must have received primary therapy (i.e., radical prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy)
• * If patient has a rising PSA after radical prostatectomy, salvage radiotherapy must have been offered
• Evidence of biochemical progression as determined by 3 PSA measurements, each higher than the previous value and meeting the following criteria:
• * The second PSA (PSA2) must be obtained at least 8 weeks after the first (PSA1)
• * The third PSA (PSA3) must be obtained at least 2 weeks after the PSA2 and within the past 4 weeks
• * The PSA3 must be \> 2.0 ng/mL and ≤ 20 ng/mL
• Must not have received more than 1 course of prior androgen ablation, defined as treatment with a luteinizing hormone-releasing hormone agonist resulting in a castrate testosterone level AND a PSA nadir ≤ 0.1 followed by subsequent withdrawal of androgen ablation and recovery of testosterone to a non-castrate level
• No evidence of metastatic disease on radionuclide bone scan and CT scan performed within the past 8 weeks
• * Retroperitoneal lymphadenectomy ≤ 2 cm is not considered metastatic for purposes of this study
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• WBC \> 2,500/mm³
• ANC ≥ 1,500/mm³
• Hemoglobin \> 9.0 g/dL
• Platelet count ≥ 100,000/mm³
• Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• PT/INR ≤ 1.3
• Serum testosterone normal
• Fertile patients must use effective contraception
• No active autoimmune disease or history of autoimmune disease requiring treatment with systemic immunosuppression including, but not limited to, any of the following:
• * Inflammatory bowel disease
• * Systemic lupus erythematosus
• * Systemic vasculitis
• * Scleroderma
• * Multiple sclerosis
• * Hemolytic anemia
• * Sjögren syndrome
• * Sarcoidosis
• No known active infection
• No uncontrolled concurrent illness including, but not limited to, any of the following:
• * Systemic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Psychiatric illness/social situations that would limit compliance with study requirements
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide acetate, bicalutamide, or sargramostim (GM-CSF)
• No known sensitivity to materials of bovine origin
• No hypersensitivity to GM-CSF or to any of the other components of CG1940/CG8711, which includes fetal bovine serum, dimethyl sulfoxide (DMSO), and hydroxyethyl starch and may include small amounts of porcine trypsin and DNase
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• More than 4 weeks since prior and no concurrent systemic corticosteroids
• * Use of inhaled corticosteroids for asthma or chronic obstructive pulmonary disease (COPD) is permitted
• More than 4 weeks since prior and no concurrent chemotherapy or other cancer therapy
• More than 4 weeks since prior and no concurrent use of herbal products (e.g., saw palmetto or PC-SPES)
• At least 4 weeks since prior and no other concurrent investigational agents
• No other concurrent anticancer commercial agents or therapies
• Prior androgen ablation administered concomitantly with primary radiotherapy allowed