Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer
NCT00514072 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2012-08-09
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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