A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation
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.
Interventional
Allocation: Randomized, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to PSA progression
No
James L. Gulley, MD, PhD, FACP
Principal Investigator
National Cancer Institute (NCI)
United States: Food and Drug Administration
CDR0000559937
NCT00514072
March 2007
Name | Location |
---|---|
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |