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NCT00254397 · ClinicalTrials.gov registry record · Phase 2
Melanoma Vaccine With Peptides and Leuprolide
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT00254397: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00254397 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00254397, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the drug leuprolide will increase the level of immune cells in your body. Researchers will also want to know if this drug given together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor fighting immune cells (T cells) to fight melanoma cells. Primary Objective: 1\. To compare the tumor-specific immune responses to melanoma-specific peptide vaccines, gp100 and MAGE-3 in the presence or absence of a luteinizing hormone-releasing hormone (LHRH) agonist-Leuprolide, in patients with stage IIb and III melanoma, uveal melanoma or stage IV melanoma that the metastatic lesion(s) has been surgically removed. Secondary Objectives: 1. To evaluate the kinetics of enhanced thymic activity measured by TREC analysis and flow cytometric analysis following sex hormone ablation by Leuprolide in melanoma patients. 2. To assess whether there are significant differences in overall quality of life (QOL) between patients receiving Leuprolide to those not receiving leuprolide.
Primary Outcome
Reactivity to the gp100 peptide in each participant defined as \>10 tetramer positive cells per 10\^4 CD8+ T-cells as determined by the tetramer analysis at 3 months following initial vaccine. Number of participants with response as defined reported. The primary end point of this clinical study was the comparison of tumor-specific immune responses to melanoma-specific peptide vaccines, gp100 and MAGE-3 in the presence or absence of Leuprolide. Gp209-2M/HLA-A\*0201 tetramers that are commercial
Interventions
- DRUG Leuprolide
- BIOLOGICAL GP100: 209-217(210M) Peptide
- BIOLOGICAL MAGE-3 Peptide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2005-11 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00254397 record still lists
NCT00254397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Leuprolide is the first listed.
NCT00254397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00254397 about?
NCT00254397 is a clinical study titled "Melanoma Vaccine With Peptides and Leuprolide". The goal of this clinical research study is to learn if the drug leuprolide will increase the level of immune cells in your body. Researchers will also want to know if this drug given together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor fighting immune cells (T cells) ...
What is the current status of trial NCT00254397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2005-11. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00254397?
The interventions under investigation include: Leuprolide (DRUG), GP100: 209-217(210M) Peptide (BIOLOGICAL), MAGE-3 Peptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00254397?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00254397's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 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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