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NCT00616564 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
A Phase 2 study, sponsored by Mt. Sinai Medical Center, Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00616564 is a Phase 2 study that has completed, run by Mt. Sinai Medical Center, Miami. The registered enrollment target is 36 participants.
The verdict
NCT00616564, a Phase 2 study, has completed, sponsored by Mt. Sinai Medical Center, Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.
Interventions
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00616564
The ClinicalTrials.gov registry entry for NCT00616564 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mt. Sinai Medical Center, Miami, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GM-CSF is the first listed.
NCT00616564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00616564 about?
NCT00616564 is a clinical study titled "Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma". High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.
What is the current status of trial NCT00616564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2006-02. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00616564?
The interventions under investigation include: GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00616564?
This trial is sponsored by Mt. Sinai Medical Center, Miami, which has 13 total clinical trials registered on ClinicalTrials.gov.
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