drugset / Trial / NCT00742911

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

NCT00742911

Phase 1 Completed 21 enrolled University of Utah
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Copper Gluconate Small molecule 2 mg Oral
Subject Copper Gluconate Small molecule 4 mg Oral
Subject Copper Gluconate Small molecule 6 mg Oral
Subject Copper Gluconate Small molecule 8 mg Oral
Subject Disulfiram Small molecule 250 mg Oral

Indications