Tests disulfiram and copper with liposomal doxorubicin for hard-to-treat sarcomas
Tests whether combining disulfiram, copper and liposomal doxorubicin is safe in adults with sarcoma.
Plain-language title generated from the registry record
Registry title: Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
Key facts
- Where
- Cleveland, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Case Comprehensive Cancer Center
- Trial code
- NCT05210374
- Record updated
- 6 August 2026
- Original description
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.Read full original descriptionShow less
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas
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.
Inclusion: Must have histologically confirmed relapsed or refractory sarcoma; Must have measurable disease by RECIST criteria at study enrollment; Performance status of Karnofsky/Lansky ≥50%; Must have normal organ and marrow function as defined below:; Absolute neutrophil count ≥1,000/mcL; Platelet count ≥ 100,000/mcL; Total bilirubin within normal institutional limits; AST (SGOT) ≤ 2.5 X institutional upper limit of normal; ALT (SGPT) ≤ 2.5 X institutional upper limit of normal; Serum Creatinine ≤1.5X institutional limit of normal; Must be able to swallow pills or consume the contents of the DSF and Capsules sprinkled on food; Participants, or parent/guardians for participants <18 years old (yo), must have the ability to understand and the willingness to sign a written informed consent document; Must abstain from alcohol during study; Prior treatment toxicities must have stabilized or resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia, neuropathy and hematologic criteria (must meet normal organ and marrow function criteria above); Participants ≥18yo must agree to pre-and post-treatment core needle tumor biopsies. For participants <18yo biopsies are optional. Biopsies will not be performed if deemed unsafe by interventional radiologists that will be performing the procedure and is not part of the study team to avoid bias; Must abstain from sexual intercourse or used appropriate, highly-effective birth control measures.
Exclusion: Has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the participant's safety or the study data integrity; Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy; Has a history of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class or any of their excipients. The participant exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of Liposomal Doxorubicin Prescribing Information package inserts or on the Investigator's Brochure for DSF/Cu; Know condition preventing safe administration of copper such as a copper allergy or Wilson's Disease; Is currently enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of their sarcoma; Is unwilling or unable to comply with study procedures; Investigator feels participation in this study would be harmful or of no benefit to the potential participant.