Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy
Condition: Melanoma
MeSH terms: Melanoma
Intervention: disulfiram and chelated zinc
Intervention MeSH terms: Disulfiram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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