Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy
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|ClinicalTrials.gov Identifier: NCT00571116|
Recruitment Status : Terminated (Halted because of slow accrual and lack of study funding)
First Posted : December 11, 2007
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Disulfiram Drug: Arsenic trioxide||Phase 1|
I. Evaluate the tolerability of disulfiram and arsenic trioxide administration as a therapeutic combination. (Phase IB)
l. Determine the response rate (complete and partial responses) and time to progression of previously treated patients with metastatic malignant melanoma when treated with disulfiram plus Arsenic Trioxide. (Phase II)
OUTLINE: This is a dose-escalation study of arsenic trioxide.
Patients receive disulfiram orally (PO) twice daily and arsenic trioxide intravenously (IV) over 1-2 hours on Monday through Friday, alternating two weeks on treatment followed by two weeks off treatment. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy (Phase 1b)|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Disulfiram and arsenic trioxide
Patients receive disulfiram 250 mg PO twice daily and arsenic trioxide IV over 1-2 hours on Monday through Friday, alternating two weeks on treatment followed by two weeks off treatment. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
The Arsenic trioxide dose will be escalated or reduced until a tolerable dose is reached. Arsenic trioxide will be administered at a starting dose of 0.05 mg/kg. If the initial dose is tolerated, the patient will be dose escalated to 0.10 mg/kg/day. If the first dose escalation is tolerated, then a second dose escalation will be attempted to 0.15 mg/kg/day, the current dose recommended for leukemia. Dosing will be continued for two weeks on alternating with two weeks off as long as tolerated to a maximum of 60 doses.
Drug: Arsenic trioxide
- Dose Escalation: Identification of Maximum Tolerated Dose [ Time Frame: Up to 6 years ]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 additional weeks, followed by two weeks off. If the first dose escalation is tolerated, then a second dose escalation will be attempted to 0.15 mg/kg/day, the current dose recommended for leukemia. The 0.15 mg/kg/day dose will be continued for two weeks on alternating with two weeks off as long as this is tolerated to a maximum of 60 doses. For patients developing grade III/IV toxicity at a given dose level, they will be dose reduced by one level and remain on that dose for the trial.
- Response rate (complete or partial response) [ Time Frame: Up to 6 years ]Will be calculated as percentage of the study population. Data will be summarized in tabular form for publication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571116
|United States, California|
|Chao Family Comprehensive Cancer Center, University of California, Irvine|
|Orange, California, United States, 92868|
|Principal Investigator:||John P Fruehauf, M.D. PhD||Chao Family Comprehensive Cancer Center|