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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
disulfiram and chelated zinc
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Disulfiram and chelated zinc

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Progression Free Survival

    Full Information

    First Posted
    March 10, 2014
    Last Updated
    December 21, 2015
    Sponsor
    University of Utah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02101008
    Brief Title
    Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Utah

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Disulfiram and chelated zinc
    Arm Type
    Other
    Arm Description
    There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
    Intervention Type
    Drug
    Intervention Name(s)
    disulfiram and chelated zinc
    Primary Outcome Measure Information:
    Title
    Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc
    Description
    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.
    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).
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    Every 56 days - for up to two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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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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