Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
Last Update Posted : 2023-01-26
The aim of the trial
- The aim of this trial is to test the safety and effectiveness of disulfiram and copper gluconate with liposomal doxorubicin in sarcoma. The researchers think that disulfiram may help to make cancers more sensitive to doxorubicin. This means it would work better. This trial is for people with sarcoma that has returned or not responded to treatment. People with osteosarcoma can take part in the trial.
- Country
- United States,
- Locations
- Cleveland,
- Trial Type
- Interventional
- Trial Phase
- Phase 1,
- Trial Status
- Recruiting
- Minimum age
- 1 Year
- Maximum age
- -
- Key Contact
- Matteo Trucco, MD, +1 216-444-8950, truccom@ccf.org,
- Clinical Trial ID
- NCT05210374
Key Information
- Everyone in the trial will receive all of the drugs.
How the treatment works
- Disulfiram is a drug that blocks an enzyme called ALDH. ALDH may be involved in making cancers resistant to chemotherapy drugs.
- Copper gluconate is a dietary food supplement. It has been shown to improve how disulfiram works.
- Doxorubicin is a chemotherapy drug.
- Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.
Who is the trial for?
- The below points are a summary of who can enter the trial.
- People with sarcoma that has returned or not responded to treatment.
- People who have had a sample of tumour analysed to confirm the diagnosis.
- People with cancer that can be measured by RECIST. Your doctor will know this.
- People with a Karnofsky/Lansky performance status greater than 49%.
- People with adequate liver, kidney, and bone marrow function. You will have tests to check this.
- People who can swallow tablets
- People who have sufficiently recovered from previous treatment.
- People who are 18 years or older must agree to have a core needle tumour biopsy before and after treatment.
- People must agree to use contraception during the study.
Who is the trial not for?
- The below points are a summary of who can’t enter the trial.
- People who have active infections needing systemic (full body) treatment.
- People with a known sensitivity to any of the drug components.
- People with medical conditions that may put them at risk or affect the trial. The trial team will discuss this.
- People who are having another cancer treatment in a clinical trial.
Disclaimer
- ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.