Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

NCT00514072 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-08-09

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

BCG vaccine

given intradermally

BIOLOGICAL

prostate cancer vaccine ONY-P1

given intradermally

OTHER

placebo

given intradermally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Kael-GemVax Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • James L. Gulley, MD, PhD, FACP · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00514072 on ClinicalTrials.gov