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 : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Disulfiram Drug: Arsenic trioxide||Phase 1 Phase 2|
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 :||15 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 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.
Drug: Arsenic trioxide
- Tolerability of disulfiram in combination with arsenic trioxide [ Time Frame: Up to 6 years ]
- 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|