Liposomal Doxorubicin (Doxil) for Sarcoma

Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, OH
SarcomaLiposomal Doxorubicin (Doxil) - Drug
Any Age
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Relapsed Sarcomas

Treatment Effectiveness

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: At 2 months

At 2 months
Percent of participants with tumor response evaluated using RECIST v1.1
Day 8
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Day 28
Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin
Day 30
Median Event free survival
Median Overall Survival (OS)
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
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Liposomal Doxorubicin (Doxil) · No Placebo Group · Phase 1

DSF/CuExperimental Group · 3 Interventions: Liposomal Doxorubicin (Doxil), Copper Gluconate, Disulfiram · Intervention Types: Drug, Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Copper Gluconate
Completed Phase 1
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 2 months

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
433 Previous Clinical Trials
30,554 Total Patients Enrolled
5 Trials studying Sarcoma
211 Patients Enrolled for Sarcoma
Matteo Trucco, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

Eligibility Criteria

Age Any Age · All Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
What site did they apply to?
Cleveland Clinic, Case Comprehensive Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Are there opportunities for new enrollees to join this experiment?

"According to the data hosted on, 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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.