Old alcoholism drug repurposed to fight tough sarcomas
NCT ID NCT05210374
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This early-stage trial is testing whether adding disulfiram (a drug used for alcohol dependence) and copper gluconate to a standard chemotherapy (Doxil) is safe for people with sarcomas that have returned or not responded to prior treatments. About 24 participants will take these drugs by mouth and by IV over several cycles. The main goal is to find the safest dose and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- disulfiram, copper gluconate, and liposomal doxorubicin (Doxil)
- What this could lead to
- If it works, this could point toward a new treatment option for sarcomas that have stopped responding to standard therapy.
- What could go wrong
- This is a very early phase 1 trial with only 24 participants, focused on safety and dosing. It is too soon to know if the combination will be effective, and there may be significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic, Case Comprehensive Cancer Center
RECRUITINGCleveland, Ohio, 44122, United States