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NCT00003224 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase 1 study of Melanoma (Skin), sponsored by University of Virginia.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT00003224: Completed Phase 1 study of Melanoma (Skin), sponsored by University of Virginia.
NCT00003224 is a Phase 1 study of Melanoma (Skin) that has completed, run by University of Virginia. The registered enrollment target is 22 participants, below the 136-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003224, a Phase 1 study of Melanoma (Skin), has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.
Primary Outcome
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
Conditions Studied
Interventions
- BIOLOGICAL QS21
- BIOLOGICAL IFA (incomplete Freund's adjuvant)
- BIOLOGICAL p946
- BIOLOGICAL p946/tet-p
- BIOLOGICAL Tet-p
Study Locations (1)
Virginia
- Cancer Center, University of Virginia HSC - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 1996-02 |
| Phase | Phase 1 |
What the finished NCT00003224 record still lists
NCT00003224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 136-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which QS21 is the first listed.
NCT00003224 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT00003224 about?
NCT00003224 is a clinical study titled "Vaccine Therapy in Treating Patients With Metastatic Melanoma". RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I t...
What is the current status of trial NCT00003224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 1996-02.
What conditions does trial NCT00003224 study?
This clinical trial studies the following conditions: Melanoma (Skin).
What interventions are being tested in trial NCT00003224?
The interventions under investigation include: QS21 (BIOLOGICAL), IFA (incomplete Freund's adjuvant) (BIOLOGICAL), p946 (BIOLOGICAL), p946/tet-p (BIOLOGICAL), Tet-p (BIOLOGICAL).
Who is sponsoring clinical trial NCT00003224?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003224 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma (Skin)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00003224's enrollment target sits among peer trials
22 19th of 30 higher than 11 of 30 other Melanoma (Skin) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma (Skin) 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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