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RECRUITING
NCT05210374
PHASE1

Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-03-09

Completion Date

2026-12-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Disulfiram

To be taken orally (PO) daily in the AM, rounded for pill size (max 480mg/day). To be administered day 1-7 of lead-in week and day 1-28 cycles Cycle length: 28 days, maximum 12 cycles Level -1 (150mg/m\^2/day) Level 0 (225mg/m\^2/day) Level 1 (300mg/m\^2/day), max 480mg/day

DRUG

Copper Gluconate

To be taken orally (PO), 5.2mg/m2/day daily in the PM, rounded for pill size (max 9mg/day) To be administered day 1-7 Lead-in week and day 1-28 cycles Cycle length: 28 days, maximum 12 cycles

DRUG

Liposomal Doxorubicin (Doxil)

To be given IV, 30mg/m2/dose To be administered day 1 of cycles Cycle length: 28 days, maximum 12 cycles

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States