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Disulfiram, Copper Gluconate, and Liposomal Doxorubicin for Relapsed Sarcomas

This study is testing a new combination of medicines for people with sarcomas that have come back or haven't responded to previous treatments. It combines disulfiram (a drug used for alcoholism), copper gluconate (a dietary supplement), and liposomal doxorubicin (a chemotherapy drug). Researchers want to see how safe this combination is and what dose works best. They believe disulfiram, with copper gluconate, might help make liposomal doxorubicin more effective against cancer. You may be able to join if you are 18 or older, have a confirmed sarcoma that has returned or is resistant to treatment, and meet certain health requirements. The study aims to measure safety and how well participants can take the drugs, and will also look at tumor response and survival. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 24 participants. It is testing different dose levels of disulfiram and copper gluconate in combination with liposomal doxorubicin.
What's involved
You would take disulfiram and copper gluconate by mouth daily for part of each 28-day cycle, and receive liposomal doxorubicin intravenously (IV) on day 1 of each cycle, for up to 12 cycles.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 30 days after your last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05210374

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~24 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:DisulfiramCopper GluconateLiposomal Doxorubicin (Doxil)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines
Measured over up to 30 days after last treatment
+4 more outcomes measured

Conditions

Relapsed Sarcomas

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Ewing SarcomaOsteosarcomaRhabdomyosarcomaSarcoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Matteo Trucco, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Case Comprehensive Cancer Center

Who to contact

Matteo Trucco, MD
[email protected]
+1 216-444-8950
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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.
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.
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.
Know condition preventing safe administration of copper such as a copper allergy or Wilson's Disease.
Investigator feels participation in this study would be harmful or of no benefit to the potential participant

What this trial measures

  • Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelinesup to 30 days after last treatment

    Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines

  • Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicinat end of cycle 1 (day 28)

    RP2D of DSF/Cu in combination with liposomal doxorubicin

  • Number of participants able to take at least 80% of the drug doses during the first cycle of treatmentup to 30 days after last treatment

    Feasibility: Number of participants able to take at least 80% of the drug doses during the first cycle of treatment, assessed by the medication diary patients will be asked to keep

  • Number of dose-limiting toxicities (DLT)up to 30 days after last treatment

    Tolerability, as total number of defined as number of DLTs

  • Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0up to 30 days after last treatment

    Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0