RECRUITING

Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas

Conditions

Relapsed Sarcomas Sarcoma,osteosarcoma rhabdomyosarcoma Ewing sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas

Quick Facts

Study Start:2023-03-09

Study Completion:2025-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05210374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Matteo Trucco, MD

CONTACT

+1 216-444-8950

truccom@ccf.org

Principal Investigator

Matteo Trucco, MD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44122

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Matteo Trucco, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09

Study Completion Date2025-04-01

Study Record Updates

Study Start Date2023-03-09

Study Completion Date2025-04-01

Terms related to this study

Keywords Provided by Researchers

Sarcoma,
osteosarcoma
rhabdomyosarcoma
Ewing sarcoma

Additional Relevant MeSH Terms

Relapsed Sarcomas