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NCT00089063 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00089063: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00089063 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089063, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.
Primary Outcome
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
Interventions
- DRUG Montanide ISA 51 VG
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL gp100 antigen
- BIOLOGICAL MART-1 antigen
- BIOLOGICAL tyrosinase peptide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-06 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
What the finished NCT00089063 record still lists
NCT00089063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Montanide ISA 51 VG is the first listed.
NCT00089063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00089063 about?
NCT00089063 is a clinical study titled "Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma". This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an im...
What is the current status of trial NCT00089063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2004-06. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00089063?
The interventions under investigation include: Montanide ISA 51 VG (DRUG), incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), MART-1 antigen (BIOLOGICAL), tyrosinase peptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00089063?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00089063's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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