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Phase I Study of Disulfiram and Copper Gluconate for the Treatment of Refractory Solid Tumors Involving the Liver

NCT00742911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-10-31

No results posted yet for this study

Summary

OBJECTIVES:

Primary Objectives

• Determine the safety and toxicity profile of co-administration of disulfiram and copper gluconate for the treatment of refractory malignancies that have metastasized to the liver.

Secondary Objectives

* Determine if disulfiram and copper gluconate induce measurable responses for the treatment of hepatic metastases from solid tumors.
* Qualitative assessment of the induction of S-glutathionylation in proteins of circulating leukocytes in patients treated with disulfiram and copper gluconate.

Conditions

Interventions

DRUG

Disulfiram

Patients will take a pill of disulfiram at a fixed dose of 250 mg with their evening meal. This dose of disulfiram used to treat alcoholism. We will start by administering 2 mg of copper as copper gluconate along with 250 mg disulfiram. Patients must not consume beverages containing alcohol while taking disulfiram.

DRUG

Copper Gluconate

Commercially available. Copper gluconate has long been manufactured and sold as a food supplement. Copper gluconate should be taken separately from disulfiram, and if possible with breakfast. Copper gluconate should not be administered to individuals with Wilson's disease or a family history of Wilson's disease. Patients will receive 2 mg, 4mg, 6mg or 8mg daily

Sponsors & Collaborators

Principal Investigators

  • Kenneth Grossmann, MD, PhD · Huntsman Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00742911 on ClinicalTrials.gov