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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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

Qualifiers

Must have histologically confirmed relapsed or refractory sarcoma.

Must have measurable disease by RECIST criteria at study enrollment

Performance status of Karnofsky/Lansky ≥50%

Absolute neutrophil count ≥1,000/mcL

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Disulfiram
  • Copper Gluconate
  • Liposomal Doxorubicin (Doxil)

Treatment groups

24 Participants
are divided into 1 treatment group