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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer.
Full description
OBJECTIVES: I. Evaluate the effect of prime and boost strategies using recombinant fowlpox prostate specific antigen (PSA) vaccine and recombinant vaccinia PSA vaccine on biochemical PSA progression in patients with stage D0 prostate cancer who have completed local treatment. II. Assess the tolerability and toxicity of these prime and boost treatment regimens in these patients. III. Evaluate the effects of these prime and boost treatment regimens on cellular immunity in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to HLA-2 typing (positive vs negative vs unknown). Patients are randomized to one of three treatment arms. Arm I: Patients receive intramuscular fowlpox prostate specific antigen (PSA) vaccine at weeks 0, 6, 12, and 18. Arm II: Patients receive intramuscular fowlpox PSA vaccine at weeks 0, 6, and 12 and intradermal vaccinia PSA vaccine at week 18. Arm III: Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6, 12, and 18. Patients are followed at week 24, then every 3 months until year 2, every 6 months until year 5, and annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS: Histologically proven prostate cancer limited to the prostate (including seminal vesicle and/or local lymph node involvement) with elevated PSA (greater than 2 ng/ml) following surgery or rising PSA following radiotherapy Negative bone scan and CT scan of abdomen and pelvis No PSA progression during chemotherapy, hormonal therapy (including steroids), or neoadjuvant or adjuvant androgen ablation therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: Not specified Pulmonary: Not specified Other: No active untreated infection No known infection with HIV No concurrent medical conditions that would prevent compliance No history or evidence of active eczema or psoriasis or other contraindications to vaccinia virus administration (i.e., allergy) No significant allergy or hypersensitivity to eggs No evidence of immunosuppression Must be able to avoid contact with high risk individuals (immunosuppressed patients, children under 3, pregnant women, or patients with a history of or active eczema or other exfoliative diseases) for 7-10 days after immunization (household contacts must not be high risk) Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 6 months since prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics At least 6 months since prior hormonal therapy (including steroids) and recovered Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy of prostate and recovered Surgery: See Disease Characteristics At least 3 months since prior prostate surgery and recovered Other: Prior vaccinia immunization required OR Patient recollection of immunization and appropriate vaccination site scar
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Data sourced from clinicaltrials.gov
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