RecruitingPhase 1NCT05210374

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

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

24 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of disulfiram (a drug usually used for alcohol dependence) with copper gluconate and liposomal doxorubicin (a chemotherapy) for people with sarcoma — a type of cancer affecting bones, muscles, or connective tissues — that has returned or stopped responding to previous treatments. **You may be eligible if...** - You have been confirmed to have relapsed or treatment-resistant sarcoma - You have measurable disease that can be evaluated on scans - You are generally able to function and care for yourself (Karnofsky/Lansky score of 50% or higher) - Your blood counts and organ function are within acceptable ranges - You are able to swallow pills **You may NOT be eligible if...** - You have an active, uncontrolled infection - You have an allergy to any of the study drugs or copper (including Wilson's Disease) - You are enrolled in another cancer treatment trial - You consume alcohol (you must abstain during the study) - You have a serious psychiatric or medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisulfiram

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

DRUGCopper 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

DRUGLiposomal 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

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NCT05210374