Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to test the safety of combining the disulfiram (DSF) and copper gluconate (Cu) to liposomal doxorubicin to treat patients with sarcomas that recurred or did not respond to initial treatment.

Clinical Trial Description

DSF blocks an enzyme called aldehyde dehydrogenase (ALDH). ALDH breaks down substances in the body that can be toxic. ALDH also appears to be important for making many cancers resistant to chemotherapy drugs like liposomal doxorubicin. The study team believes giving DSF with liposomal doxorubicin will help make the cancers sensitive to the liposomal doxorubicin, making it work better. Cu is an FDA approved dietary food supplement and has been shown in laboratory research to improve how DSF works, which is the rational for giving DSF with Cu. It is currently unknown if and at what dose DSF is safe to be given in this combination. Though DSF has been used for over 60 years for the treatment of alcoholism, this is the first time DSF/Cu is being tested in combination with liposomal doxorubicin in humans. The primary objectives of this study are to: Measure the feasibility, safety and tolerability of DSF/Cu in combination with liposomal doxorubicin Secondary objectives of this study are to: Measure tumor response, survival, and pharmacokinetics of the combination. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05210374
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Matteo Trucco, MD
Phone +1 216-444-8950
Status Recruiting
Phase Phase 1
Start date March 9, 2023
Completion date November 1, 2024