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NCT00972309 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00972309: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00972309 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00972309, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
Background: * PSA (prostate specific antigen) is a protein found on normal and cancerous prostate cells. Levels of this protein are used to identify men who are at risk for prostate cancer and to monitor responses to treatment in men who have been diagnosed with prostate cancer. * Research has shown that men who continue to have an elevated PSA level following primary treatment for prostate cancer are at increased risk for cancer progression. Studies have shown that the change in PSA levels over time, or PSA doubling time (PSADT), can be accurate in predicting how quickly the cancer is likely to progress. Individuals with a PSADT of less than 3 months are at extremely high risk for disease progression and death from prostate cancer. Individuals with a PSADT of greater than 15 months have a very low risk of death from prostate cancer. * T-cell receptor alternate reading frame protein (TARP) is a protein that is found in about 95% of prostate cancers and is known to stimulate the immune system. The TARP prostate cancer vaccine is made from pieces of the TARP protein called peptides and includes peptides that have been modified to make them more effective at stimulating immunity. Although these TARP peptides have been shown to stimulate the immune systems of mice, information is needed to determine if they also stimulate the immune system in humans. Since it is unclear what is the best way to give peptide vaccines, the TARP peptides will be given with substances known to stimulate the immune system or in a vaccine made with the patient s own cells. Objectives: * To determine the immune systems response to vaccination with TARP peptides. * To determine the safety and toxicity of TARP peptide vaccination. * To determine if vaccination with the TARP prostate cancer vaccine can slow down PSADT in men with an intermediate PSADT of 3 to 15 months. Eligibility: * Males 18 years of age and older who have completed their primary treatment for prostate cancer, have stage D0
Primary Outcome
The number of participants in each arm with positive response determined by 3-fold increase over baseline in the number of positive cells by interferon (IFN) gamma enzyme-linked immunosorbent spot (ELISpot) at week 24. Presence of tumor antigen-specific T cells (positive response) mean the vaccine was able to generate immune response (i.e. immunogenicity) which is a good outcome.
Interventions
- BIOLOGICAL T-cell receptor alternate reading frame protein (TARP) peptide vaccine
- BIOLOGICAL T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-05-11 |
| Est. Completion | 2015-02-04 |
| Phase | Phase 1 |
What the finished NCT00972309 record still lists
NCT00972309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which T-cell receptor alternate reading frame protein (TARP) peptide vaccine is the first listed.
NCT00972309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00972309 about?
NCT00972309 is a clinical study titled "A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer". Background: * PSA (prostate specific antigen) is a protein found on normal and cancerous prostate cells. Levels of this protein are used to identify men who are at risk for prostate cancer and to monitor responses to treatment in men who have been diagnosed with prostate cancer. * Research has show...
What is the current status of trial NCT00972309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2009-05-11. Estimated completion is 2015-02-04.
What interventions are being tested in trial NCT00972309?
The interventions under investigation include: T-cell receptor alternate reading frame protein (TARP) peptide vaccine (BIOLOGICAL), T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00972309?
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 NCT00972309's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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