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NCT00256230 · ClinicalTrials.gov registry record · Phase 1
Disulfiram in Patients With Metastatic Melanoma
A Phase 1 study, sponsored by John P. Fruehauf.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00256230 is a Phase 1 study that has completed, run by John P. Fruehauf. The registered enrollment target is 7 participants.
The verdict
NCT00256230, a Phase 1 study, has completed, sponsored by John P. Fruehauf.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Melanoma remains a malignancy that is largely resistant to chemotherapy. Metastatic disease responds poorly to the treatments used today with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%, and complete responses are rare. DTIC-based regimen has been recognized as a standard chemotherapy for advanced melanoma, and temozolomide demonstrated efficacy equal to that of DTIC and is an oral alternative agent that also crosses the blood brain barrier. Randomized phase III trials have shown no survival benefit of adding other agents (cisplatin, BCNU, and tamoxifen). Biochemotherapy is being developed extensively with moderate improvement in the responsive rate (approximately 50%) and is under evaluation in randomized trial to identify whether there is survival benefit to this strategy, compared with chemotherapy alone. Recently, a randomized phase III study comparing chemotherapy (cisplatin, dacarbazine, and tamoxifen) with biochemotherapy (the same chemotherapy regimen plus high-dose IL-2 and interferon alfa) have shown 44% response rate for biochemotherapy vs. 27% for chemotherapy. However, the tendency toward an increased response rate in patients who received biochemotherapy did not translate into an increase in overall survival, and there was, in fact, a trend for a survival advantage in patients receiving chemotherapy alone (median survival: 10.7 vs 15.8 months). New agents (or combinations) need to be developed for this refractory malignancy. The purpose of this study is to determine the response rate and evaluate the toxicity of disulfiram (DSF) in the treatment of Stage IV melanoma. The advantages of using DSF in this phase I/II trial are the following: * DSF has been used as a drug for many years for the treatment of alcoholism. Its mechanism, pharmacokinetics, toxicity/tolerable dose are well known, and this drug is relatively non-toxic by itself at therapeutic dose. Doses of greater than 3000mg/m2 can cause rever
Interventions
- DRUG Disulfiram (DSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2002-01 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00256230
The ClinicalTrials.gov registry entry for NCT00256230 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John P. Fruehauf, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Disulfiram (DSF) is the first listed.
NCT00256230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00256230 about?
NCT00256230 is a clinical study titled "Disulfiram in Patients With Metastatic Melanoma". Melanoma remains a malignancy that is largely resistant to chemotherapy. Metastatic disease responds poorly to the treatments used today with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%, and complete responses are rare. DTIC-based regimen has been re...
What is the current status of trial NCT00256230?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2002-01. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00256230?
The interventions under investigation include: Disulfiram (DSF) (DRUG).
Who is sponsoring clinical trial NCT00256230?
This trial is sponsored by John P. Fruehauf, which has 4 total clinical trials registered on ClinicalTrials.gov.
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