[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657917":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":29,"overallOfficials":45,"centralContacts":50,"locations":55,"responsibleParty":72,"collaborators":13,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":13,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":13,"enrollmentInfo":82,"targetDuration":13,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":13,"overallStatus":91,"whyStopped":13,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0","Through study completion; an average of 1 year",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Primary Objectives:\n\n* Evaluate the safety and feasibility of CDT (disulfiram + copper gluconate) during RT in patients undergoing radiotherapy within the thorax.\n* Evaluate the progression free survival (PFS) time.\n\nSecondary Objectives:\n\n* Monitor all treatment-related adverse events from CDT during RT.\n* Assess local control (LC) at 6 months.\n\nExploratory Objectives:\n\n* Evaluate cuproptosis-related gene expression and biomarkers of copper metabolism in the baseline biopsy tissues and associate with treatment response. We aim to identify cuproptosis gene signatures (e.g., FDX1, LIAS, DLAT, PDHA1, MT1E, MT1X) as predictive biomarkers of therapeutic response.\n* Evaluate the potential for continued CDT during adjuvant immunotherapy",[22],{"label":23,"type":24,"description":13,"interventionNames":25},"Treatment with Disulfiram + Copper Gluconate + Concurrent LCT","EXPERIMENTAL",[26,27,28],"Drug: Disulfiram 250 mg","Drug: Copper Gluconate 2 mg","Drug: Radiation Therapy",[30,37,41],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Disulfiram 250 mg","Given orally once daily",[23],[36],"Antabuse",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":13},"Copper Gluconate 2 mg","Given orally three times daily",[23],{"type":31,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"Radiation Therapy","Delivered per institutional standards (radiotherapy alone in 10-15 fractions as local consolidation therapy).",[23],[46],{"name":47,"affiliation":48,"role":49},"Steven Lin, MD, PHD","UT MD Anderson","PRINCIPAL_INVESTIGATOR",[51],{"name":47,"role":52,"phone":53,"phoneExt":13,"email":54},"CONTACT","(713) 563-8490","shlin@mdanderson.org",[56],{"facility":48,"status":13,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Houston","Texas","77030","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-95.36327,29.76328,{"lat":66,"lon":65},[69,71],{"name":47,"role":52,"phone":70,"phoneExt":13,"email":54},"713-563-8490",{"name":47,"role":49,"phone":13,"phoneExt":13,"email":13},{"type":73,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100657917","phase-2-minter-trial-metal-intervention-and-therapy-with-radiotherapy-in-thoracic-cancer-using-copper-donor-therapy-a-phase-2-open-label-study-100657917",false,"NCT07843537","MINTER Trial: Metal Intervention aNd ThErapy With Radiotherapy In Thoracic Cancer Using Copper Donor Therapy: A Phase 2, Open-Label Study","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced or metastatic disease of any histology that will receive chest radiation\n2. Scheduled to receive RT as part of definitive local consolidation therapy (LCT) (not palliative)\n3. Induction systemic therapy allowed, but just not concurrently given (washout for at least 3 weeks before start of CDT and RT)\n4. Age ≥18 years.\n5. ECOG 0-2.\n6. Adequate organ and marrow function within 28 days prior to enrollment defined as:\n\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL\n   * Platelet count ≥100 × 10⁹\u002FL\n   * Hemoglobin ≥9 g\u002FdL\n   * Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL\u002Fmin\n   * Total bilirubin ≤1.5 × ULN (≤3 × ULN for patients with known Gilbert's syndrome)\n   * AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with hepatic metastases)\n7. Ability to provide written informed consent.\n8. Prior thoracic radiation allowed as long as cumulative organ as risk constraints are met\n\nExclusion Criteria:\n\n1. Uncontrolled intercurrent illness.\n2. Known hypersensitivity to Disulfiram.\n3. Contraindications to radiation therapy.\n4. Inability to stay away from alcohol products during the use of Disulfiram.\n5. Wilson's Disease (copper overload disorder)\n6. Hepatic dysfunction with AST\u002FALT\u002Fbilirubin levels that are outside 2.5 X normal range (≤2.5 × ULN)\n7. Hypersensitivity to copper-containing compounds","ALL","18 Years",{"count":83,"type":84},30,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This study is being done to test whether adding two drugs-disulfiram and copper gluconate-to radiation therapy can help overcome this resistance and improve treatment outcomes. When disulfiram is combined with copper, it forms a substance that may increase stress within cancer cells and lead to a specific type of cancer cell death knowns as \"cuproptosis\".",[90],"Thoracic Cancer","NOT_YET_RECRUITING","2026-09-21",{"date":94,"type":95},"2026-09-28","ACTUAL",{"date":97,"type":84},"2027-03-01",{"date":99,"type":84},"2032-03-30",{"name":5,"class":6},1]