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

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 Capsulessprinkled on food.

• Participants, or parent/guardians for participants <18 years old (yo), must have theability to understand and the willingness to sign a written informed consentdocument.

• Must abstain from alcohol during study.

• Prior treatment toxicities must have stabilized or resolved to ≤ Grade 1 accordingto NCI CTCAE Version 5.0 except alopecia, neuropathy and hematologic criteria (mustmeet 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 ifdeemed unsafe by interventional radiologists that will be performing the procedureand is not part of the study team to avoid bias.

• Must abstain from sexual intercourse or used appropriate, highly-effective birthcontrol measures.

Exclusion Criteria:

• Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemictherapy

• Has a history of allergy or hypersensitivity to any of the study drugs, theirpharmaceutical class or any of their excipients. The participant exhibits any of theevents outlined in the Contraindications or Special Warnings and Precautionssections of Liposomal Doxorubicin Prescribing Information package inserts or on theInvestigator's Brochure for DSF/Cu.

• Has a concomitant serious medical or psychiatric illness that, in the opinion of theinvestigator, could compromise the participant's safety or the study data integrity.

• Is currently enrolled in any other clinical protocol or investigational trialinvolving administration of antineoplastic compounds for the treatment of theirsarcoma.

• Is unwilling or unable to comply with study procedures.

• Know condition preventing safe administration of copper such as a copper allergy orWilson's Disease.

• Investigator feels participation in this study would be harmful or of no benefit tothe potential participant