Actively Recruiting
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
Led by Case Comprehensive Cancer Center · Updated on 2026-03-27
24
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have histologically confirmed relapsed or refractory sarcoma.
- Must have measurable disease by RECIST criteria at study enrollment.
- Performance status of Karnofsky/Lansky 50% or higher.
- Normal organ and marrow function defined as absolute neutrophil count of at least 1,000/mcL.
- Platelet count of at least 100,000/mcL.
- Total bilirubin within normal institutional limits.
- AST (SGOT) no greater than 2.5 times the institutional upper limit of normal.
- ALT (SGPT) no greater than 2.5 times the institutional upper limit of normal.
- Serum creatinine less than or equal to 1.5 times the institutional limit of normal.
- Must be able to swallow pills or consume the contents of DSF and capsules sprinkled on food.
- Participants or parent/guardians for those under 18 years must understand and be willing to sign informed consent.
- Must abstain from alcohol during the study.
- Prior treatment toxicities must have stabilized or resolved to grade 1 or less except alopecia, neuropathy, and hematologic criteria.
- Participants 18 years or older must agree to pre- and post-treatment tumor biopsies; biopsies are optional for participants under 18.
- Must abstain from sexual intercourse or use highly effective birth control measures.
You will not qualify if you...
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Allergy or hypersensitivity to any study drugs, their classes, or excipients.
- Serious medical or psychiatric illness that could compromise safety or study data.
- Currently enrolled in another clinical trial with antineoplastic compounds for sarcoma.
- Unwilling or unable to comply with study procedures.
- Known condition preventing safe copper administration such as copper allergy or Wilson's Disease.
- Investigator believes participation would be harmful or provide no benefit.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44122
Actively Recruiting
Research Team
M
Matteo Trucco, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here