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NCT00005916 · ClinicalTrials.gov registry record · Phase 2
PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00005916: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00005916 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005916, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will test the ability of an experimental vaccine to increase the number of tumor-fighting immune cells (lymphocytes) in patients with localized prostate cancer and prevent the disease from recurring following radiation therapy. The vaccine is intended to stimulate lymphocytes to target and attack cells containing a protein called prostate specific antigen, or PSA. It is composed of the following parts: * rV-PSA: Vaccinia virus plus human DNA that produces PSA (prostate specific antigen) * rV-B7.1: Vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets) * rF-PSA: Fowlpox virus plus human DNA that produces PSA * GM-CSF: Drug that boosts the immune system. * IL-2: Drug that boosts the immune system. Patients 18 years of age and older with prostate cancer confined to the prostate who have received a smallpox vaccine sometime in the past and who do not have a history of allergy to eggs may be eligible for this study. Candidates are screened with a complete medical history and physical examination, blood tests, and skin tests (similar to those for allergies or tuberculosis) to assess immune function. Participants are randomly assigned to receive one of the following three treatments: Group 1 - standard radiation therapy plus the experimental vaccine; Group 2 - standard radiation therapy without the vaccine; Group 3 - standard radiation therapy with the vaccine, but with a different dose of IL-2 from Group 1. Patients in the vaccine groups receive injections in the arm or thigh in 28-day treatment cycles, as follows: * GM-CSF: Days 1 through 4 of the first week * IL-2 5: for Group 1, 5 days in the second week of each cycle; for Group 3, 14 days beginning in the second week of each cycle * rV-PSA and rV-B7.1: Day 2 of the first cycle only * rF-PSA (booster shots): Every 28 days, beginning day 2 of the second cycle (i.e., days 30, 58, 86, etc.) Treatment continues for eight cycles unless serious side effect
Interventions
- DRUG rV-PSA
- DRUG rF-PSA
- DRUG rV-B7.1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2000-06-13 |
| Est. Completion | 2005-12-22 |
| Phase | Phase 2 |
What the finished NCT00005916 record still lists
NCT00005916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 3 interventions - of which rV-PSA is the first listed.
NCT00005916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005916 about?
NCT00005916 is a clinical study titled "PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer". This study will test the ability of an experimental vaccine to increase the number of tumor-fighting immune cells (lymphocytes) in patients with localized prostate cancer and prevent the disease from recurring following radiation therapy. The vaccine is intended to stimulate lymphocytes to target an...
What is the current status of trial NCT00005916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2000-06-13. Estimated completion is 2005-12-22.
What interventions are being tested in trial NCT00005916?
The interventions under investigation include: rV-PSA (DRUG), rF-PSA (DRUG), rV-B7.1 (DRUG).
Who is sponsoring clinical trial NCT00005916?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005916's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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