Combining disulfiram, copper gluconate, and liposomal doxorubicin for treating relapsed sarcomas
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas
This study is testing a new treatment that combines disulfiram, copper gluconate, and liposomal doxorubicin to see if it can help people with relapsed sarcomas feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | Doxorubicin, chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05210374 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of a new treatment approach for patients with relapsed or refractory sarcomas by combining disulfiram (DSF) and copper gluconate (Cu) with liposomal doxorubicin. DSF is known to inhibit an enzyme that contributes to chemotherapy resistance, potentially enhancing the effectiveness of liposomal doxorubicin. The study will assess the tolerability of this combination, as well as its impact on tumor response and patient survival. This is the first time this combination is being tested in humans, making it a novel approach in cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed relapsed or refractory sarcomas who have measurable disease and meet specific health criteria.
Not a fit: Patients with non-relapsed sarcomas or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with sarcomas that have not responded to previous therapies.
How similar studies have performed: While this specific combination has not been tested before, the individual components have shown promise in laboratory settings, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Matteo Trucco, MD — Cleveland Clinic, Case Comprehensive Cancer Center
- Study coordinator: Matteo Trucco, MD
- Email: truccom@ccf.org
- Phone: +1 216-444-8950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.