NCT05210374 Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
| NCT ID | NCT05210374 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Relapsed Sarcomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2023-03-09 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Matteo Trucco, MD
PRINCIPAL INVESTIGATOR
Cleveland Clinic, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05210374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Sarcomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05210374 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05210374 currently recruiting?
Yes, NCT05210374 is actively recruiting participants. Contact the research team at truccom@ccf.org for enrollment information.
Where is the NCT05210374 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05210374 clinical trial?
NCT05210374 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Matteo Trucco, MD at Cleveland Clinic, Case Comprehensive Cancer Center. The trial plans to enroll 24 participants.