[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455424":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":63,"collaborators":22,"id":65,"slug":22,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":22,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":22,"enrollmentInfo":73,"targetDuration":22,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":47,"whyStopped":22,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DSF\u002FCu","EXPERIMENTAL","A 3+3 dose escalation design will be used to determine the recommended phase 2 dose (RP2D) of DSF\u002FCu in combination with liposomal doxorubicin. There will be a 7 day \"lead-in\" week of Disulfiram (DSF)\u002FCopper 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\u002Fm2\u002Fdose IV\n\nCycle length: 28 days Maximum 12 cycles",[13,14,15],"Drug: Disulfiram","Drug: Copper Gluconate","Drug: Liposomal Doxorubicin (Doxil)",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Disulfiram","To be taken orally (PO) daily in the AM, rounded for pill size (max 480mg\u002Fday).\n\nTo be administered day 1-7 of lead-in week and day 1-28 cycles\n\nCycle length: 28 days,\n\nmaximum 12 cycles Level -1 (150mg\u002Fm\\^2\u002Fday) Level\n\n0 (225mg\u002Fm\\^2\u002Fday) Level 1 (300mg\u002Fm\\^2\u002Fday), max\n\n480mg\u002Fday",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Copper Gluconate","To be taken orally (PO), 5.2mg\u002Fm2\u002Fday daily in the PM, rounded\n\nfor pill size (max 9mg\u002Fday) To be administered day 1-7\n\nLead-in week and day 1-28 cycles Cycle length: 28\n\ndays, maximum 12 cycles",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Liposomal Doxorubicin (Doxil)","To be given IV, 30mg\u002Fm2\u002Fdose\n\nTo be administered day 1 of cycles\n\nCycle length: 28 days, maximum 12 cycles",[9],[32,33,34],"Pegylated Liposomal Doxorubicin (PLD)","Doxorubicin HCl Liposome Injection","Dox-SL",[36],{"name":37,"affiliation":38,"role":39},"Matteo Trucco, MD","Cleveland Clinic, Case Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":22,"email":44},"CONTACT","+1 216-444-8950","truccom@ccf.org",[46],{"facility":38,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Cleveland","Ohio","44122","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-81.69541,41.4995,{"lat":57,"lon":56},[60,62],{"name":37,"role":42,"phone":61,"phoneExt":22,"email":44},"216-444-8950",{"name":37,"role":39,"phone":22,"phoneExt":22,"email":22},{"type":64,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100455424",false,"NCT05210374","Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas","Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas","Inclusion Criteria:\n\n* Must have histologically confirmed relapsed or refractory sarcoma.\n* Must have measurable disease by RECIST criteria at study enrollment\n* Performance status of Karnofsky\u002FLansky ≥50%\n* Must have normal organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * Platelet count ≥ 100,000\u002FmcL\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal\n  * Serum Creatinine ≤1.5X institutional limit of normal\n* Must be able to swallow pills or consume the contents of the DSF and Capsules sprinkled on food.\n* Participants, or parent\u002Fguardians for participants \\\u003C18 years old (yo), must have the ability to understand and the willingness to sign a written informed consent document.\n* Must abstain from alcohol during study.\n* 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).\n* Participants ≥18yo must agree to pre-and post-treatment core needle tumor biopsies. For participants \\\u003C18yo 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.\n* Must abstain from sexual intercourse or used appropriate, highly-effective birth control measures.\n\nExclusion Criteria:\n\n* Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy\n* 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\u002FCu.\n* 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.\n* Is currently enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of their sarcoma.\n* Is unwilling or unable to comply with study procedures.\n* Know condition preventing safe administration of copper such as a copper allergy or Wilson's Disease.\n* Investigator feels participation in this study would be harmful or of no benefit to the potential participant","ALL","18 Years",{"count":74,"type":75},24,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","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.",[81],"Relapsed Sarcomas",[83,84,85,86],"Sarcoma,","osteosarcoma","rhabdomyosarcoma","Ewing sarcoma","2026-06-04",{"date":89,"type":90},"2026-06-05","ACTUAL",{"date":92,"type":90},"2023-03-09",{"date":94,"type":75},"2026-12-31",{"name":5,"class":6},1]