Spots Global Cancer Trial Database for PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer

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Trial Identification

Brief Title: PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer

Official Title: Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer

Study ID: NCT00003871

Conditions

Prostate Cancer

Interventions

fowlpox virus vaccine vector

recombinant vaccinia prostate-specific antigen vaccine

Study Description

Brief Summary: 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.

Detailed 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.