Trial Outcomes & Findings for Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy (NCT NCT02101008)

Last Updated: 2023-12-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

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.)

Results posted on

2023-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disulfiram and Chelated Zinc n=12 Participants There is only one arm. All patients are treated wtih disulfiram and chelated zinc. disulfiram and chelated zinc
Age, Continuous	65 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.)

Outcome measures

Outcome measures
Measure	Disulfiram and Chelated Zinc n=12 Participants 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).
Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc	0 participants

SECONDARY outcome

Timeframe: Every 56 days - for up to two years

Outcome measures

Outcome measures
Measure	Disulfiram and Chelated Zinc n=12 Participants 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).
Progression Free Survival	51.8 days Standard Deviation 39.8

Adverse Events

Disulfiram and Chelated Zinc

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Disulfiram and Chelated Zinc n=12 participants at risk There is only one arm. All patients are treated wtih disulfiram and chelated zinc. disulfiram and chelated zinc
Psychiatric disorders Confusion	8.3% 1/12

Other adverse events

Other adverse events
Measure	Disulfiram and Chelated Zinc n=12 participants at risk There is only one arm. All patients are treated wtih disulfiram and chelated zinc. disulfiram and chelated zinc
General disorders Fatigue	58.3% 7/12
Infections and infestations rash	16.7% 2/12
Skin and subcutaneous tissue disorders pruritis	16.7% 2/12
Gastrointestinal disorders diarrhea	25.0% 3/12
Gastrointestinal disorders nausea	33.3% 4/12
Gastrointestinal disorders consitpation	8.3% 1/12
Gastrointestinal disorders vomiting	8.3% 1/12
Nervous system disorders dysgeusia	16.7% 2/12
Investigations Aspartate aminotransferase	8.3% 1/12
Investigations Alanine aminotransferase	8.3% 1/12
Nervous system disorders ataxia	16.7% 2/12
Nervous system disorders tremor	8.3% 1/12
Psychiatric disorders confusion	33.3% 4/12
Nervous system disorders headache	16.7% 2/12
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12
Renal and urinary disorders renal insufficiency	8.3% 1/12

Additional Information

Kenneth Grossmann

Huntsman Cancer Institute

Phone: 801-587-4289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place