- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02101008
Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Disulfiram and chelated zinc
There is only one arm.
All patients are treated wtih disulfiram and chelated zinc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc
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 15 months.)
|
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.)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: Every 56 days - for up to two years
|
Every 56 days - for up to two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Alcohol Deterrents
- Acetaldehyde Dehydrogenase Inhibitors
- Disulfiram
Other Study ID Numbers
- HCI37833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on disulfiram and chelated zinc
-
Psykiatrisk Center GentofteUnknown
-
Yale UniversityNational Institute on Drug Abuse (NIDA)Completed
-
University of RochesterNot yet recruitingAge-Related Macular Degeneration | Retinitis Pigmentosa | Retinal Dystrophies | Alcohol Use Disorder | Stargardt DiseaseUnited States
-
CES UniversityNutreva S.A.S.; Foundation Child Care - FANCompleted
-
University of WashingtonRecruitingInherited Retinal Dystrophy Primarily Involving Sensory RetinaUnited States
-
Hadassah Medical OrganizationAugusta Hospital, BerlinCompletedNon-small Cell Lung CancerIsrael
-
John P. FruehaufCompleted
-
Baylor College of MedicineCompletedCocaine AddictionUnited States
-
Universidad de GuanajuatoLaboratorios Doctor MacíasEnrolling by invitation
-
First People's Hospital of HangzhouCollege of Pharmaceutical Sciences at Zhejiang University; The Innovation Institute...Not yet recruitingChemotherapy;Advanced Gastric Cancer;Cisplatin;DisulfiramChina