Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00514072
• Study type: Interventional
• Source: Kael-GemVax Co., Ltd.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2007