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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Melanoma Drug: disulfiram and chelated zinc Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Disulfiram and chelated zinc
There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
Drug: disulfiram and chelated zinc



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Every 56 days - for up to two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02101008     History of Changes
Other Study ID Numbers: HCI37833
First Posted: April 1, 2014    Key Record Dates
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
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Disulfiram
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action