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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disulfiram and chelated zinc | Other | There is only one arm. All patients are treated wtih disulfiram and chelated zinc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disulfiram and chelated zinc | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Every 56 days - for up to two years |
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Inclusion Criteria:
The subjects must fulfill all the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
Exclusion Criteria:
Potential study subjects who meet any of the following criteria are not eligible for participation in the study:
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| ID | Title | Description |
|---|---|---|
| FG000 | Disulfiram and Chelated Zinc | There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Disulfiram and Chelated Zinc | There is only one arm. All patients are treated wtih disulfiram and chelated zinc. disulfiram and chelated zinc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 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.) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Disulfiram and Chelated Zinc | There is only one arm. All patients are treated wtih disulfiram and chelated zinc. disulfiram and chelated zinc |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusion | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Grossmann | Huntsman Cancer Institute | 801-587-4289 | kenneth.grossmann@hci.utah.edu |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004221 | Disulfiram |
| ID | Term |
|---|---|
| D004050 | Ditiocarb |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Progression Free Survival | Posted | Mean | Standard Deviation | days | Every 56 days - for up to two years |
|
|
|
| 1 |
| 12 |
| 12 |
| 12 |
| rash | Infections and infestations |
|
| pruritis | Skin and subcutaneous tissue disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| nausea | Gastrointestinal disorders |
|
| consitpation | Gastrointestinal disorders |
|
| vomiting | Gastrointestinal disorders |
|
| dysgeusia | Nervous system disorders |
|
| Aspartate aminotransferase | Investigations |
|
| Alanine aminotransferase | Investigations |
|
| ataxia | Nervous system disorders |
|
| tremor | Nervous system disorders |
|
| confusion | Psychiatric disorders |
|
| headache | Nervous system disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| renal insufficiency | Renal and urinary disorders |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004220 | Disulfides |
| D013440 | Sulfides |
| D013457 | Sulfur Compounds |