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

NCT02101008 | Completed Phase 2 Results DMC

• 1 other identifier: HCI37833
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc

  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.

  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.)

Secondary Outcomes (1)

• Progression Free Survival

  Every 56 days - for up to two years

Study Arms (1)

Disulfiram and chelated zinc

OTHER

There is only one arm. All patients are treated wtih disulfiram and chelated zinc.

Drug: disulfiram and chelated zinc

Interventions

disulfiram and chelated zinc DRUG

Disulfiram and chelated zinc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Melanoma

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Results Point of Contact

• Title: Kenneth Grossmann
• Organization: Huntsman Cancer Institute

kenneth.grossmann@hci.utah.edu

801-587-4289

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: April 1, 2014
• Study Start: March 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: November 27, 2013
• Last Updated: December 13, 2023
• Results First Posted: January 28, 2016

Record last verified: 2023-12