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

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 2

Conditions

Melanoma

Treatments

Drug: disulfiram and chelated zinc

Study type

Interventional

Funder types

Other

Identifiers

NCT02101008

HCI37833

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.
Age of 18 years or more
ECOG performance status of 0 - 2
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
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
Not currently receiving other cancer chemotherapy
Not currently participating in another study
Baseline AST and ALT not greater than 2.0 X upper limit of normal
Able and willing to provide informed consent and to comply with study procedures
Able to ingest oral medications
No known allergy to disulfiram or zinc gluconate
Willing to refrain from ingestion of alcoholic beverages while on the study
Serum copper within the normal range at baseline, or if outside the normal range, the PI will review for clinical significance

Exclusion criteria

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

Participation in another clinical trial of a therapeutic drug during the past 30 days
Addiction to alcohol or cocaine
Baseline AST or ALT greater than 2.0 X upper limit of normal
Unable to ingest oral medications
Unable to undergo CT scanning because of inability to lie recumbent in the scanner;
Actively receiving cytotoxic cancer chemotherapy agents
Evidence of thiuram allergy (may present as contact allergy to rubber or elastic)
Current use of sertraline and cyclosporine
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
Need for warfarin or theophylline, the metabolism of which is likely influenced by disulfiram
Pregnant women and nursing mothers are not allowed to enroll on this study
Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives