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NCT00450463 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 3
- Study locations
NCT00450463: Completed Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT00450463 is a Phase 2 study of Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 64 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450463, a Phase 2 study of Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 3
- Study locations
Study Summary
Background: * Flutamide is an approved drug for prostate cancer that blocks the effects of testosterone on prostate cancer cells and may slow the progression of the disease. * The vaccine in this study consists of a priming vaccine called PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM (triad of costimulatory molecules), made from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox virus. DNA (Deoxyribonuceic acid) is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA) a protein that is normally produced by the patients tumor cells. * GM-CSF (granulocyte macrophage colony stimulating factor), given along with the vaccine, is a chemical that boosts the immune system. It is used in this study to try to increase the usefulness of the vaccine by increasing the number of immune cells at the vaccination site. Objectives: -To determine if treatment with a prostate cancer vaccine plus flutamide is more effective than flutamide alone in delaying disease progression in patients with prostate cancer. Eligibility: * Patients 18 years of age and older with androgen-insensitive prostate cancer that has not spread beyond the prostate gland. * Patients with a rising PSA (prostatic specific antigen) who have already been treated with anti-iandrogen therapy (either bicalutamide or nilutamide). Design: * There are two treatment groups in this study. Group A receives only flutamide; group B receive flutamide plus vaccine. * Patients in both groups receive flutamide by mouth three times a day. * Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29 and again every 4 weeks. All vaccines are given as injections under the skin. * Patients have blood tests for PSA levels every month and scans every 3 months until the disease worsens. * After 3 months of therapy, patients receiving in gro
Conditions Studied
Interventions
- DRUG Sargramostim (GM-CSF, Leukine)
- DRUG Flutamide (Eulexin)
- BIOLOGICAL PROSTVAC-F/ TRICOM
- BIOLOGICAL PROSTVAC-V/TRICOM
Study Locations (3)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
New Jersey
- Cancer Institute of New Jersey - New Brunswick
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2007-02-23 |
| Est. Completion | 2017-06-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00450463
The ClinicalTrials.gov registry entry for NCT00450463 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Sargramostim (GM-CSF, Leukine) is the first listed.
NCT00450463 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Maryland, New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00450463 about?
NCT00450463 is a clinical study titled "Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer". Background: * Flutamide is an approved drug for prostate cancer that blocks the effects of testosterone on prostate cancer cells and may slow the progression of the disease. * The vaccine in this study consists of a priming vaccine called PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V...
What is the current status of trial NCT00450463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2007-02-23. Estimated completion is 2017-06-08.
What conditions does trial NCT00450463 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00450463?
The interventions under investigation include: Sargramostim (GM-CSF, Leukine) (DRUG), Flutamide (Eulexin) (DRUG), PROSTVAC-F/ TRICOM (BIOLOGICAL), PROSTVAC-V/TRICOM (BIOLOGICAL).
Who is sponsoring clinical trial NCT00450463?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00450463 being conducted?
This trial has 3 study locations across Maryland, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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