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NCT00791271 · ClinicalTrials.gov registry record · Phase 1
Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00791271: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00791271 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00791271, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied. The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are more effective and/or better tolerated.
Primary Outcome
Dose limiting toxicity defined as any treatment related toxicity that meets one or more of the following criteria: Any grade 3 or 4 non-hematologic toxicity regardless of duration, except: 1. Grade 3 nausea or vomiting occurring without maximal antiemetic therapy. 2. Grade 3 diarrhea that occurs following without adequate loperamide therapy. * Grade 4 thrombocytopenia. * Grade 4 neutropenia lasting \> 2 weeks or associated with infection. * Any toxicity that results in a treatment de
Interventions
- DRUG Decitabine
- DRUG Pegylated Interferon Alpha-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2008-09-02 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
Why NCT00791271 stopped before completion
NCT00791271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT00791271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00791271 about?
NCT00791271 is a clinical study titled "Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion". The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied. The goals of the second phase are to learn ...
What is the current status of trial NCT00791271?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2008-09-02. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00791271?
The interventions under investigation include: Decitabine (DRUG), Pegylated Interferon Alpha-2b (DRUG).
Who is sponsoring clinical trial NCT00791271?
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 NCT00791271's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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