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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00254397
The ClinicalTrials.gov registry entry for NCT00254397 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leuprolide is the first listed.
NCT00254397 reports 0 study locations.
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.
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