Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Phase 2

• Conditions: Prostate Cancer
• Interventions: Other: placebo; Biological: BCG vaccine; Biological: prostate cancer vaccine ONY-P1

• Registration Number: NCT00514072
• Lead Sponsor: Kael-GemVax Co., Ltd.

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-08
• Last Update Posted: 2012-08-09
• Primary Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm II	placebo	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.
Arm I	BCG vaccine	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 I	prostate cancer vaccine ONY-P1	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.

Primary Outcome Measures

Name	Time	Method
Time to PSA progression

Secondary Outcome Measures

Name	Time	Method
Toxicity
Immunologic response as assessed by ELISPOT assay
PSA kinetics (doubling time/velocity) of treatment
Time to testosterone recovery

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States