Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hormone-refractory adenocarcinoma of the prostate Rising PSA after orchiectomy and/or while receiving at least 1 regimen of luteinizing hormone-releasing hormone (LHRH) PSA must have risen at least 0.5 ng/mL from baseline on 2 successive measurements during and/or after hormonal therapy PSA greater than 1.0 ng/mL If on antiandrogen therapy, must undergo antiandrogen withdrawal for at least 6 weeks and still have evidence of rising PSA After prior bicalutamide, must undergo withdrawal for at least 6 weeks and still have evidence of rising PSA Testosterone no greater than 50 ng/mL if no prior orchiectomy No metastatic disease by bone scan and CT scan or MRI of the abdomen and pelvis and by CT scan or x-ray of the chest No active or prior CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 OR ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute lymphocyte count at least 600/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT no greater than 4 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Urinalysis normal OR Proteinuria no greater than 1 g/24-hour urine collection No hematuria or abnormal sediment unless underlying cause is nonrenal Immunologic: HIV negative No altered immune function No autoimmune disease, including the following: Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma Myasthenia gravis Goodpasture syndrome Addison's disease, Hashimoto's thyroiditis, or active Graves' disease No known allergy or untoward reaction to prior vaccination with vaccinia virus No known allergy to eggs No active or prior eczema or other eczematoid skin disorders No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds) Other: No other serious concurrent illness No active infections within the past 3 days No history of seizures, encephalitis, or multiple sclerosis No close or household contact for at least 2 weeks after each vaccinia virus inoculation with the following high-risk individuals: Children under 5 years of age Pregnant or nursing women Individuals with active or prior eczema or other eczematoid skin disorders, atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds Immunosuppressed or immunodeficient (by disease or therapy) individuals, including those with HIV infection No other malignancy within the past 3 years except squamous cell or basal cell skin cancer or other curatively treated malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: Must have prior vaccinia for smallpox immunization No other concurrent biologic therapy Chemotherapy: No prior chemotherapy for prostate cancer No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy (6 weeks for bicalutamide) and recovered If disease progression on LHRH antagonist, must continue to receive that LHRH agent or undergo surgical castration No concurrent steroids unless topical or inhaled No other concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 50% of nodal groups No concurrent radiotherapy Surgery: See Disease Characteristics See Endocrine therapy At least 4 weeks since prior surgery and recovered No prior splenectomy Other: No concurrent homeopathic therapy with PC-SPES or genistein
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support