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NCT01603212 · ClinicalTrials.gov registry record · Phase 1
Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01603212: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01603212 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603212, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied. The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.
Primary Outcome
Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any grade 3 or 4 non-hematological toxicity excluding manageable N/V, diarrhea and fatigue and manageable/replaceable grade 3 or 4 electrolyte abnormalities, and appearance of new squamous cell skin cancers. Toxicity that may result in delaying next course for more than 3 weeks. Any grade 4 neutropenia more than 7 days duration or Grade 4 thrombocytope
Interventions
- DRUG IL-2
- DRUG Vemurafenib
- DRUG Interferon Alpha-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-07-18 |
| Est. Completion | 2017-07-05 |
| Phase | Phase 1 |
What the finished NCT01603212 record still lists
NCT01603212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which IL-2 is the first listed.
NCT01603212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01603212 about?
NCT01603212 is a clinical study titled "Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor". The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be stu...
What is the current status of trial NCT01603212?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-07-18. Estimated completion is 2017-07-05.
What interventions are being tested in trial NCT01603212?
The interventions under investigation include: IL-2 (DRUG), Vemurafenib (DRUG), Interferon Alpha-2b (DRUG).
Who is sponsoring clinical trial NCT01603212?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01603212's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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