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New treatment option for Relapsed Sarcomas
Official title Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
ClinicalTrials.gov ID: NCT05210374
What this study is testing
What is Disulfiram?
Disulfiram is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed sarcomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the participant's safety or the...
- Is currently enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment...
- 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.
See the full eligibility 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...
- 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 treatment radiologists that will be...
- Must abstain from sexual intercourse or used appropriate, highly-effective birth control measures.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.