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Copper Supplement
Disulfiram + Copper Gluconate + Liposomal Doxorubicin for Sarcoma
Phase 1
Recruiting
Led By Matteo Trucco, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have histologically confirmed relapsed or refractory sarcoma
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat sarcomas. The drugs are disulfiram (DSF), copper gluconate (Cu), and liposomal doxorubicin. The trial will test the safety of this combination.
Who is the study for?
This trial is for patients with sarcomas that didn't get better after initial treatment. They must have a certain level of health, be able to swallow pills or take them with food, not drink alcohol, and use effective birth control if needed. People allergic to the drugs used or with serious illnesses that could affect safety or data integrity can't join.Check my eligibility
What is being tested?
The study tests combining disulfiram (DSF) and copper gluconate (Cu) with liposomal doxorubicin in treating stubborn sarcomas. It aims to see if this mix is safe for those whose cancer has come back or resisted first-line treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to liver function changes, blood cell counts alterations, potential digestive issues from swallowing pills, and general discomforts like fatigue which are common in cancer therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My sarcoma has come back or didn't respond to treatment.
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My side effects from previous treatments are mild or gone, except for hair loss, nerve issues, or blood-related conditions.
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I, or my guardian if I'm under 18, can understand and agree to sign the consent form.
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I can swallow pills or take them with food if needed.
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I can do most of my daily activities by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of dose-limiting toxicities (DLT)
Number of participants able to take at least 80% of the drug doses during the first cycle of treatment
Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0
+2 moreSecondary outcome measures
Median Event free survival
Median Overall Survival (OS)
Percent of participants with tumor response evaluated using RECIST v1.1
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DSF/CuExperimental Treatment3 Interventions
A 3+3 dose escalation design will be used to determine the recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin. There will be a 7 day "lead-in" week of Disulfiram (DSF)/Copper Gluconate (Cu). The disulfiram and the copper gluconate will be dosed once a day. Disulfiram in the morning and copper gluconate in the evening. Same total daily dose every 4 week (28 days) administration of liposomal doxorubicin (Doxil) 30mg/m2/dose IV
Cycle length: 28 days Maximum 12 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copper gluconate
FDA approved
Disulfiram
FDA approved
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,886 Total Patients Enrolled
4 Trials studying Sarcoma
76 Patients Enrolled for Sarcoma
Matteo Trucco, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My sarcoma has come back or didn't respond to treatment.My side effects from previous treatments are mild or gone, except for hair loss, nerve issues, or blood-related conditions.I have an ongoing serious infection that needs treatment.I do not have a copper allergy or Wilson's Disease.I am willing to undergo tumor biopsies if safe and I am 18 or older.I am not part of another cancer drug study.My organ and bone marrow functions are normal.I, or my guardian if I'm under 18, can understand and agree to sign the consent form.I can swallow pills or take them with food if needed.I can do most of my daily activities by myself.
Research Study Groups:
This trial has the following groups:- Group 1: DSF/Cu
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for new enrollees to join this experiment?
"According to the data hosted on clinicaltrials.gov, this research endeavor is not currently recruiting participants; its listing was initially published on December 1st 2022 and most recently edited a little over two months ago. Nevertheless, there are 443 other trials actively enrolling patients at present."
Answered by AI
What are the intended objectives of this research project?
"This clinical trial, which is planned to be monitored for a month following the last treatment of subjects, has two main objectives. The primary goal is to document the number of participants who experience Adverse Events categorized as Grade 3 or higher according to CTCAE5.0 standards. Secondary goals include evaluating the pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin through clearance and average steady state concentrations measurements on samples collected from participants; determining median overall survival (OS) and Event free survival times based on RECIST v1.1 criteria; and measuring at least 20% relative increase in target lesions"
Answered by AI
Is there any danger associated with taking Liposomal Doxorubicin (Doxil)?
"Liposomal Doxorubicin (Doxil)'s safety is not fully established yet, so we assume a score of 1 on this scale. This indicates that it's currently in its first phase of clinical trials and there is limited evidence regarding effectiveness and safety."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What site did they apply to?
Cleveland Clinic, Case Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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