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NCT00289341 · ClinicalTrials.gov registry record · Phase 1
Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.
A Phase 1 study, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00289341: Completed Phase 1 study, sponsored by Rockefeller University.
NCT00289341 is a Phase 1 study that has completed, run by Rockefeller University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00289341, a Phase 1 study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells, whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example) in the body and to activate other cells of the immune system to mount an attack on that foreign antigen. Each participant will be randomized into either Arm 1 (experimental treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will be given the vaccine and three boosters as an injection. After the placebo phase, each participant in Arm 2 will crossover to the treatment phase so that all participants will eventually receive the experimental treatment.
Primary Outcome
Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.
Interventions
- BIOLOGICAL vaccine vehicle only
- BIOLOGICAL DC/LNCaP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2002-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 1 |
What the finished NCT00289341 record still lists
NCT00289341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which vaccine vehicle only is the first listed.
NCT00289341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00289341 about?
NCT00289341 is a clinical study titled "Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.". The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells, whose role is to identif...
What is the current status of trial NCT00289341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2002-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00289341?
The interventions under investigation include: vaccine vehicle only (BIOLOGICAL), DC/LNCaP (BIOLOGICAL).
Who is sponsoring clinical trial NCT00289341?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00289341's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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