Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas (NCT05210374) | Clinical Trial Compass
RecruitingPhase 1
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
United States24 participantsStarted 2023-03-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines
Timeframe: up to 30 days after last treatment
2
Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin
Timeframe: at end of cycle 1 (day 28)
3
Number of participants able to take at least 80% of the drug doses during the first cycle of treatment
Timeframe: up to 30 days after last treatment
4
Number of dose-limiting toxicities (DLT)
Timeframe: up to 30 days after last treatment
5
Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0