Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 46 for:    disulfiram

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Drug: disulfiram and chelated zinc
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Disulfiram and Chelated Zinc
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Disulfiram and Chelated Zinc
Hide Arm/Group Description

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

disulfiram and chelated zinc

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
65
(52 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
1.Primary Outcome
Title Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram and Chelated Zinc
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame Every 56 days - for up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram and Chelated Zinc
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: days
51.8  (39.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Disulfiram and Chelated Zinc
Hide Arm/Group Description

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

disulfiram and chelated zinc

All-Cause Mortality
Disulfiram and Chelated Zinc
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Disulfiram and Chelated Zinc
Affected / at Risk (%)
Total   1/12 (8.33%) 
Psychiatric disorders   
Confusion  1/12 (8.33%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Disulfiram and Chelated Zinc
Affected / at Risk (%)
Total   12/12 (100.00%) 
Gastrointestinal disorders   
diarrhea  3/12 (25.00%) 
nausea  4/12 (33.33%) 
consitpation  1/12 (8.33%) 
vomiting  1/12 (8.33%) 
General disorders   
Fatigue  7/12 (58.33%) 
Infections and infestations   
rash  2/12 (16.67%) 
Investigations   
Aspartate aminotransferase  1/12 (8.33%) 
Alanine aminotransferase  1/12 (8.33%) 
Nervous system disorders   
dysgeusia  2/12 (16.67%) 
ataxia  2/12 (16.67%) 
tremor  1/12 (8.33%) 
headache  2/12 (16.67%) 
Psychiatric disorders   
confusion  4/12 (33.33%) 
Renal and urinary disorders   
renal insufficiency  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
pruritis  2/12 (16.67%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kenneth Grossmann
Organization: Huntsman Cancer Institute
Phone: 801-587-4289
EMail: kenneth.grossmann@hci.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02101008     History of Changes
Other Study ID Numbers: HCI37833
First Submitted: March 10, 2014
First Posted: April 1, 2014
Results First Submitted: May 23, 2014
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016