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NCT00470015 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00470015: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00470015 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00470015, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
Interventions
- BIOLOGICAL GM-CSF
- BIOLOGICAL IL-2
- BIOLOGICAL gp100 antigen
- BIOLOGICAL MART-1 antigen
- BIOLOGICAL MART-1a peptide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-03 |
| Est. Completion | 2013-01-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00470015
The ClinicalTrials.gov registry entry for NCT00470015 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which GM-CSF is the first listed.
NCT00470015 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00470015 about?
NCT00470015 is a clinical study titled "Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor...
What is the current status of trial NCT00470015?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-03. Estimated completion is 2013-01-02.
What interventions are being tested in trial NCT00470015?
The interventions under investigation include: GM-CSF (BIOLOGICAL), IL-2 (BIOLOGICAL), gp100 antigen (BIOLOGICAL), MART-1 antigen (BIOLOGICAL), MART-1a peptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00470015?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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