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NCT00694551 · ClinicalTrials.gov registry record · NA
PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT00694551: Completed NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00694551 is a NA study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00694551, a NA study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study Summary
Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive Treatment The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate cancer is the most common cancer and is the second leading cause of cancer deaths in U.S. males. It is curable when it is confined to the prostate (kept from spreading) using surgery or radiation treatments. In some patients the cancer can come back after these treatments. Treatment options for prostate cancer that comes back include procedures or medications which may have significant risks and side effects. Another plan is being looked at that uses the body's immune system to attack prostate cancer cells. A vaccine has been developed that has proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol) will be added to the vaccine to boost its ability to start the immune system.
Primary Outcome
Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.
Interventions
- BIOLOGICAL Peptide Vaccine
- DRUG Poly IC-LC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-12-02 |
| Est. Completion | 2018-12-06 |
| Phase | NA |
What the finished NCT00694551 record still lists
NCT00694551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Peptide Vaccine is the first listed.
NCT00694551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00694551 about?
NCT00694551 is a clinical study titled "PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment". Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive T...
What is the current status of trial NCT00694551?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2008-12-02. Estimated completion is 2018-12-06.
What interventions are being tested in trial NCT00694551?
The interventions under investigation include: Peptide Vaccine (BIOLOGICAL), Poly IC-LC (DRUG).
Who is sponsoring clinical trial NCT00694551?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00694551's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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