Disulfiram in Patients With Metastatic Melanoma
Tracking Information | |||||
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First Received Date ICMJE | November 17, 2005 | ||||
Last Updated Date | December 20, 2011 | ||||
Start Date ICMJE | January 2002 | ||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Determine response rate [ Time Frame: Every 8 weeks during therapy ] [ Designated as safety issue: Yes ] Complete response (CR)-Complete disappearance of all measurable and evaluable disease. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. Partial response (PR)-Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. For both CR and PR, no new lesions. All assessments use the same techniques as baseline. |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00256230 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Evaluate the toxicity of disulfiram administration [ Time Frame: Lab tests-Weeks 2, 4, 8, 12, 16, 20 and 24; X-rays/scans-Every 8 weeks ] [ Designated as safety issue: Yes ] Accelerated titration designs are used for the maximum tolerated dose. Patients will remain at one dose level for one week before escalated to the next higher dose level, providing that no grade II or III toxicity occurs. Phase II is to use the maximum tolerated dose of DSF (as described above) to determine the response rate. Evaluation of toxicities will be continued. Dose reduction (switch to the next lower dose) will be carried out if patient develops grade III/IV toxicities, and this dose reduction applies to both phase I and phase II. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Disulfiram in Patients With Metastatic Melanoma | ||||
Official Title ICMJE | Evaluation of Disulfiram in Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy, Phase I/II | ||||
Brief 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:
This study is designed to include women and minorities, but is not designed to measure differences of intervention effect. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Stage IV Melanoma | ||||
Intervention ICMJE | Drug: Disulfiram (DSF)
DSF pills at 250 mg will be given orally, two times a day. If this dose is tolerated, the dose will be escalated until the maximum tolerated dose is reached. Treatment will continue every day for 3 months or longer unless the disease gets worse, the side effects are too dangerous for the subject, or the subject decides to discontinue treatment.
Other Name: bis(diethylthiocarbamoyl) disulfide |
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Study Arm (s) | Experimental: Disulfiram
Intervention: Drug: Disulfiram (DSF) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 7 | ||||
Completion Date | August 2007 | ||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256230 | ||||
Other Study ID Numbers ICMJE | UCI 01-01, 2001-2038 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Chao Family Comprehensive Cancer Center, University of California, Irvine | ||||
Study Sponsor ICMJE | University of California, Irvine | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of California, Irvine | ||||
Verification Date | December 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |