Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy
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|ClinicalTrials.gov Identifier: NCT02101008|
Recruitment Status : Completed
First Posted : April 1, 2014
Results First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Primary Objectives Determine the response rate associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.
Secondary Objectives Determine the progression-free survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.
Determine the overall survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.
Determine the toxicity associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated zinc on in vivo protein S-glutathionylation.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: disulfiram and chelated zinc||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2013|
Disulfiram and chelated zinc
There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
Drug: disulfiram and chelated zinc
- Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc [ Time Frame: Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to five years). ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression Free Survival [ Time Frame: Every 56 days - for up to two years ]