Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Study Description

Brief Summary: RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with a placebo in treating patients with stage D0 prostate cancer.

Detailed Description: OBJECTIVES: Primary * To determine whether ONY-P1 vaccine can increase the time to PSA-defined progression in patients with androgen-dependent stage D0 prostate cancer. Secondary * To evaluate all toxicities related to ONY-P1 vaccine. * To compare the immunologic response in patients treated with ONY-P1 vaccine vs placebo. * To evaluate PSA kinetics (doubling time/velocity) of treatment. * To evaluate time to testosterone recovery following limited androgen ablation. OUTLINE: Patients are stratified according to estimated PSA doubling time (\< 12 months vs ≥ 12 months). Patients receive goserelin subcutaneously once. Approximately 3 months later, patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for up to 15 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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