Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: disulfiram and chelated zinc

• Registration Number: NCT02101008
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2013-02
• Study Completion: 2013-11-27
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Results First Submitted: 2014-05-23
• Results First Submitted QC: 2015-12-21
• Results First Posted: 2016-01-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

The subjects must fulfill all the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

1. Male and female patients with stage IV melanoma cancer with biopsy proven metastases demonstrated by imaging studies. Extent of disease should be documented by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning. At least one site of disease should be measurable by RECIST criteria.
2. Age of 18 years or more
3. ECOG performance status of 0 - 2
4. Patients must have received and progressed after or not responded to at least one cycle of first line therapy (chemotherapy, biotherapy, or biochemotherapy) or are unwilling or ineligible to undergo standard therapy
5. Patients with brain metastases along with disease at other sites are eligible to participate if their brain disease has been treated with surgery or radiation
6. Not currently receiving other cancer chemotherapy
7. Not currently participating in another study
8. Baseline AST and ALT not greater than 2.0 X upper limit of normal
9. Able and willing to provide informed consent and to comply with study procedures
10. Able to ingest oral medications
11. No known allergy to disulfiram or zinc gluconate
12. Willing to refrain from ingestion of alcoholic beverages while on the study
13. Serum copper within the normal range at baseline, or if outside the normal range, the PI will review for clinical significance

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Exclusion Criteria

Potential study subjects who meet any of the following criteria are not eligible for participation in the study:

1. Participation in another clinical trial of a therapeutic drug during the past 30 days
2. Addiction to alcohol or cocaine
3. Baseline AST or ALT greater than 2.0 X upper limit of normal
4. Unable to ingest oral medications
5. Unable to undergo CT scanning because of inability to lie recumbent in the scanner;
6. Actively receiving cytotoxic cancer chemotherapy agents
7. Evidence of thiuram allergy (may present as contact allergy to rubber or elastic)
8. Current use of sertraline and cyclosporine
9. Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have a pregnancy test before enrollment
10. Need for warfarin or theophylline, the metabolism of which is likely influenced by disulfiram
11. Pregnant women and nursing mothers are not allowed to enroll on this study
12. Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Disulfiram and chelated zinc	disulfiram and chelated zinc	There is only one arm. All patients are treated wtih disulfiram and chelated zinc.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc	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 15 months.)	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Every 56 days - for up to two years