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 cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy (Phase 1b)|
- Tolerability of disulfiram in combination with arsenic trioxide [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
- Response rate (complete or partial response) [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Will be calculated as percentage of the study population. Data will be summarized in tabular form for publication.
|Study Start Date:||September 2006|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
Other Names:Drug: Arsenic trioxide
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|