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NCT00571116 · ClinicalTrials.gov registry record · Phase 1
Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy
A Phase 1 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00571116: Clinical Trial Phase 1 study, sponsored by University of California, Irvine.
NCT00571116 is a Phase 1 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00571116, a Phase 1 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with disulfiram in treating patients with metastatic and progressive melanoma. Drugs used in chemotherapy, such as disulfiram and arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Primary Outcome
The dose will be escalated or reduced until a tolerable dose is reached. Dose toleration is determined by the absence of any grade III/IV toxicities. Arsenic trioxide will be administered intravenously at a starting dose of 0.05 mg/kg daily, 5 days per week, for 2 weeks. The patients then have 2 weeks off, followed by two weeks of daily administration. If the initial dose is tolerated, the patient will be dose escalated for the second two weeks of drug administration to 0.10 mg/kg/day for two ad
Interventions
- DRUG Disulfiram
- DRUG Arsenic trioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
Why NCT00571116 stopped before completion
NCT00571116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Disulfiram is the first listed.
NCT00571116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00571116 about?
NCT00571116 is a clinical study titled "Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy". This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with disulfiram in treating patients with metastatic and progressive melanoma. Drugs used in chemotherapy, such as disulfiram and arsenic trioxide, work in different ways to stop the growth of tumor...
What is the current status of trial NCT00571116?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2006-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00571116?
The interventions under investigation include: Disulfiram (DRUG), Arsenic trioxide (DRUG).
Who is sponsoring clinical trial NCT00571116?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00571116's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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