Relapsed SarcomasPhase 1NCT05210374
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
A Phase 1 study testing Disulfiram, Copper Gluconate and Liposomal Doxorubicin (Doxil) in people with Relapsed Sarcomas, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Sarcomas
- What is being tested?
- Disulfiram, Copper Gluconate and Liposomal Doxorubicin (Doxil)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44122
Matteo Trucco, MD, 216-444-8950, truccom@ccf.org
Matteo Trucco, MD
About this study
Official title: Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas
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.
Read the detailed description
DSF blocks an enzyme called aldehyde dehydrogenase (ALDH). ALDH breaks down substances in the body that can be toxic. ALDH also appears to be important for making many cancers resistant to chemotherapy drugs like liposomal doxorubicin. The study team believes giving DSF with liposomal doxorubicin will help make the cancers sensitive to the liposomal doxorubicin, making it work better. Cu is an FDA approved dietary food supplement and has been shown in laboratory research to improve how DSF works, which is the rational for giving DSF with Cu. It is currently unknown if and at what dose DSF is safe to be given in this combination. Though DSF has been used for over 60 years for the treatment of alcoholism, this is the first time DSF/Cu is being tested in combination with liposomal doxorubicin in humans.
The primary objectives of this study are to:
Measure the feasibility, safety and tolerability of DSF/Cu in combination with liposomal doxorubicin
Secondary objectives of this study are to:
Measure tumor response, survival, and pharmacokinetics of the combination.
- Conditions
- Relapsed Sarcomas
- Being tested
- Disulfiram, Copper Gluconate, Liposomal Doxorubicin (Doxil)
- Keywords
- Sarcoma,, osteosarcoma, rhabdomyosarcoma, Ewing sarcoma
- Medical subject headings
- Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DisulfiramDrug
To be taken orally (PO) daily in the AM, rounded for pill size (max 480mg/day).
To be administered day 1-7 of lead-in week and day 1-28 cycles
Cycle length: 28 days,
maximum 12 cycles Level -1 (150mg/m^2/day) Level
0 (225mg/m^2/day) Level 1 (300mg/m^2/day), max
480mg/day
Copper GluconateDrug
To be taken orally (PO), 5.2mg/m2/day daily in the PM, rounded
for pill size (max 9mg/day) To be administered day 1-7
Lead-in week and day 1-28 cycles Cycle length: 28
days, maximum 12 cycles
Liposomal Doxorubicin (Doxil)Drug
Also called Pegylated Liposomal Doxorubicin (PLD), Doxorubicin HCl Liposome Injection, Dox-SL
To be given IV, 30mg/m2/dose
To be administered day 1 of cycles
Cycle length: 28 days, maximum 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| DSF/Cu | Experimental | 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 Receives: Drug: Disulfiram; Drug: Copper Gluconate; Drug: Liposomal Doxorubicin (Doxil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines
Measured: up to 30 days after last treatment
Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin
RP2D of DSF/Cu in combination with liposomal doxorubicin
Measured: at end of cycle 1 (day 28)
Number of participants able to take at least 80% of the drug doses during the first cycle of treatment
Feasibility: Number of participants able to take at least 80% of the drug doses during the first cycle of treatment, assessed by the medication diary patients will be asked to keep
Measured: up to 30 days after last treatment
Number of dose-limiting toxicities (DLT)
Tolerability, as total number of defined as number of DLTs
Measured: up to 30 days after last treatment
Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0
Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0
Measured: up to 30 days after last treatment
Secondary outcomes (18)
Percent of participants with tumor response evaluated using RECIST v1.1
Tumor response will be evaluated per RECIST v1.1 criteria - percent of participants with complete response, partial response, stable disease and progressive disease reported
Measured: At 2 months
Median Overall Survival (OS)
Median OS defined as the time from participant enrollment on study to time of death
Measured: up to 30 days after last treatment
Median Event free survival
Median Event free survival defined as the time from participant enrollment on study to time of disease progression (PD) per RECIST v1.1,.
PD defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: up to 30 days after last treatment
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - Peak concentration (Cmax)
Measured: At hour 0 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - Peak concentration (Cmax)
Measured: At hour 2 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - Peak concentration (Cmax)
Measured: At hour 4 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - Peak concentration (Cmax)
Measured: At hour 24 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - Peak concentration (Cmax)
Measured: Day 1 of cycle 1 (day 8)
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 doxorubicinbased on samples collected - area under the concentration-vs-time curve (AUC)
Measured: At hour 0 of Day 1 of lead-in week
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 doxorubicinbased on samples collected - area under the concentration-vs-time curve (AUC)
Measured: At hour 2 of Day 1 of lead-in week
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 doxorubicinbased on samples collected - area under the concentration-vs-time curve (AUC)
Measured: At hour 4 of Day 1 of lead-in week
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 doxorubicinbased on samples collected - area under the concentration-vs-time curve (AUC)
Measured: At hour 24 of Day 1 of lead-in week
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 doxorubicinbased on samples collected - area under the concentration-vs-time curve (AUC)
Measured: Day 1 of cycle 1 (day 8)
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - clearance and average steady state concentrations for disulfiram and its active metabolites, S-methyl N,N-dietylthiolcarbamate (DETC-ME) and bis-diethyldithiocarbamate-copper complex (CuET)
Measured: At hour 0 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - clearance and average steady state concentrations for disulfiram and its active metabolites, S-methyl N,N-dietylthiolcarbamate (DETC-ME) and bis-diethyldithiocarbamate-copper complex (CuET)
Measured: At hour 2 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - clearance and average steady state concentrations for disulfiram and its active metabolites, S-methyl N,N-dietylthiolcarbamate (DETC-ME) and bis-diethyldithiocarbamate-copper complex (CuET)
Measured: At hour 4 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - clearance and average steady state concentrations for disulfiram and its active metabolites, S-methyl N,N-dietylthiolcarbamate (DETC-ME) and bis-diethyldithiocarbamate-copper complex (CuET)
Measured: At hour 24 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicinbased on samples collected - clearance and average steady state concentrations for disulfiram and its active metabolites, S-methyl N,N-dietylthiolcarbamate (DETC-ME) and bis-diethyldithiocarbamate-copper complex (CuET)
Measured: Day 1 of cycle 1 (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start9 Mar 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed SarcomasStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Trucco, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210374
- Sponsor's protocol ID
- CASE1720
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas
- ClinicalTrials.gov ID
- NCT05210374
- Acronym / sponsor ID
- CASE1720
- Conditions
- Relapsed Sarcomas
- Keywords
- Sarcoma,, osteosarcoma, rhabdomyosarcoma, Ewing sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DSF blocks an enzyme called aldehyde dehydrogenase (ALDH). ALDH breaks down substances in the body that can be toxic. ALDH also appears to be important for making many cancers resistant to chemotherapy drugs like liposomal doxorubicin. The study team believes giving DSF with liposomal doxorubicin will help make the cancers sensitive to the liposomal doxorubicin, making it work better. Cu is an FDA approved dietary food supplement and has been shown in laboratory research to improve how DSF works, which is the rational for giving DSF with Cu. It is currently unknown if and at what dose DSF is safe to be given in this combination. Though DSF has been used for over 60 years for the treatment of alcoholism, this is the first time DSF/Cu is being tested in combination with liposomal doxorubicin in humans.
The primary objectives of this study are to:
Measure the feasibility, safety and tolerability of DSF/Cu in combination with liposomal doxorubicin
Secondary objectives of this study are to:
Measure tumor response, survival, and pharmacokinetics of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSF/Cu | Experimental | Drug: Disulfiram, Drug: Copper Gluconate, Drug: Liposomal Doxorubicin (Doxil)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Must be able to swallow pills or consume the contents of the DSF and Capsules sprinkled on food.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DisulfiramTo be taken orally (PO) daily in the AM, rounded for pill size (max 480mg/day). To be administered day 1-7 of lead-in week and day 1-28 cycles Cycle length: 28 days, maximum 12 cycles Level -1 (150mg/m^2/day) Level 0 (225mg/m^2/day) Level 1 (300mg/m^2/day), max 480mg/day | Drug | DSF/Cu |
| Copper GluconateTo be taken orally (PO), 5.2mg/m2/day daily in the PM, rounded for pill size (max 9mg/day) To be administered day 1-7 Lead-in week and day 1-28 cycles Cycle length: 28 days, maximum 12 cycles | Drug | DSF/Cu |
| Liposomal Doxorubicin (Doxil)Also: Pegylated Liposomal Doxorubicin (PLD), Doxorubicin HCl Liposome Injection, Dox-SLTo be given IV, 30mg/m2/dose To be administered day 1 of cycles Cycle length: 28 days, maximum 12 cycles | Drug | DSF/Cu |
Primary outcome
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines
Time frame: up to 30 days after last treatment
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines
Recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin
Time frame: at end of cycle 1 (day 28)
RP2D of DSF/Cu in combination with liposomal doxorubicin
Number of participants able to take at least 80% of the drug doses during the first cycle of treatment
Time frame: up to 30 days after last treatment
Feasibility: Number of participants able to take at least 80% of the drug doses during the first cycle of treatment, assessed by the medication diary patients will be asked to keep
Number of dose-limiting toxicities (DLT)
Time frame: up to 30 days after last treatment
Tolerability, as total number of defined as number of DLTs
Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0
Time frame: up to 30 days after last treatment
Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0
18 secondary outcomes
Percent of participants with tumor response evaluated using RECIST v1.1
Time frame: At 2 months
Median Overall Survival (OS)
Time frame: up to 30 days after last treatment
Median Event free survival
Time frame: up to 30 days after last treatment
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Time frame: At hour 0 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Time frame: At hour 2 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Time frame: At hour 4 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Time frame: At hour 24 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [Peak concentration (Cmax)]
Time frame: Day 1 of cycle 1 (day 8)
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]
Time frame: At hour 0 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]
Time frame: At hour 2 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]
Time frame: At hour 4 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]
Time frame: At hour 24 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [area under the concentration-vs-time curve (AUC)]
Time frame: Day 1 of cycle 1 (day 8)
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Time frame: At hour 0 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Time frame: At hour 2 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Time frame: At hour 4 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Time frame: At hour 24 of Day 1 of lead-in week
Pharmacokinetics of DSF/Cu in combination with liposomal doxorubicin [clearance and average steady state concentrations for disulfiram and its active metabolites]
Time frame: Day 1 of cycle 1 (day 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matteo Trucco, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Disulfiram, Copper Gluconate and Liposomal Doxorubicin (Doxil) in people with Relapsed Sarcomas, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Trucco, MD (+1 216-444-8950, truccom@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by percent of participants experiencing grade 3+ with at least possible attribution to study drug using CTCAE 5.0 guidelines (time frame: up to 30 days after last treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.