Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Mt. Sinai Medical Center, Miami.
NCT00616564 is a Phase 2 study that has completed, run by Mt. Sinai Medical Center, Miami. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population
Interventions
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
What the finished NCT00616564 record still lists
NCT00616564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which GM-CSF is the first listed.
NCT00616564 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616564's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia