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NCT05210374
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
Conditions: Relapsed Sarcomas
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Case Comprehensive Cancer Center
Location: Cleveland Clinic, Case Comprehensive Cancer Center Cleveland Ohio
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 \
Source: ClinicalTrials.gov (NCT05210374). StuddyBuddy aggregates publicly available trial information.