drugset / Trial / NCT00742911
Phase I Study of Disulfiram and Copper Gluconate for the Treatment of Refractory Solid Tumors Involving the Liver
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |