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NCT00077532 · ClinicalTrials.gov registry record · Phase 2
Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma
A Phase 2 study of Melanoma (Skin), sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 179
- Enrollment target
- 1
- Study location
NCT00077532 is a Phase 2 study of Melanoma (Skin) that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 179 participants, above the 131-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (37% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00077532, a Phase 2 study of Melanoma (Skin), has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 179 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma. PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.
Conditions Studied
Interventions
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL gp100 antigen
- BIOLOGICAL ipilimumab
Study Locations (1)
Maryland
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00077532
The ClinicalTrials.gov registry entry for NCT00077532 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 131-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (37% higher). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 3 interventions - of which incomplete Freund's adjuvant is the first listed.
NCT00077532 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00077532 about?
NCT00077532 is a clinical study titled "Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma". RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a strong...
What is the current status of trial NCT00077532?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2004-03. Estimated completion is 2008-02.
What conditions does trial NCT00077532 study?
This clinical trial studies the following conditions: Melanoma (Skin).
What interventions are being tested in trial NCT00077532?
The interventions under investigation include: incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00077532?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00077532 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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