Recruiting
Phase 1

Disulfiram with Copper Gluconate & Liposomal Doxorubicin

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05210374

Conditions

Relapsed Sarcomas

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Disulfiram

Copper Gluconate

Liposomal Doxorubicin (Doxil)

Study Details

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.

Conditions

Relapsed Sarcomas

Study ID

NCT05210374

Start date

Mar 9, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DSF/Cu

A 3+3 dose escalation design will be used to determine the recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin. There will be a 7 day "lead-in" week of Disulfiram (DSF)/Copper Gluconate (Cu). The disulfiram and the copper gluconate will be dosed once a day. Disulfiram in the morning and copper gluconate in the evening. Same total daily dose every 4 week (28 days) administration of liposomal doxorubicin (Doxil) 30mg/m2/dose IV

Cycle length: 28 days Maximum 12 cycles

Interventions

Disulfiram

To be taken orally (PO) daily in the AM, rounded for pill size (max 480mg/day).

To be administered day 1-7 of lead-in week and day 1-28 cycles

Cycle length: 28 days,

maximum 12 cycles Level -1 (150mg/m\^2/day) Level

0 (225mg/m\^2/day) Level 1 (300mg/m\^2/day), max

480mg/day

Copper Gluconate

To be taken orally (PO), 5.2mg/m2/day daily in the PM, rounded

for pill size (max 9mg/day) To be administered day 1-7

Lead-in week and day 1-28 cycles Cycle length: 28

days, maximum 12 cycles

Liposomal Doxorubicin (Doxil)

To be given IV, 30mg/m2/dose

To be administered day 1 of cycles

Cycle length: 28 days, maximum 12 cycles

Primary outcome measure

  • Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines [ Time Frame: up to 30 days after last treatment ]
  • Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin [ Time Frame: at end of cycle 1 (day 28) ]
  • Number of participants able to take at least 80% of the drug doses during the first cycle of treatment [ Time Frame: up to 30 days after last treatment ]
  • Number of dose-limiting toxicities (DLT) [ Time Frame: up to 30 days after last treatment ]
  • Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0 [ Time Frame: up to 30 days after last treatment ]

Central Contacts and Locations

Central contacts

Matteo Trucco, MD

+1 216-444-8950truccom@ccf.org

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44122

Contacts

Matteo Trucco, MD

216-444-8950truccom@ccf.org

Principal Investigator:

Matteo Trucco, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Sarcoma,
  • osteosarcoma
  • rhabdomyosarcoma
  • Ewing sarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.