[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07719127":3,"trial-entities:NCT07719127":122,"trial-summary:NCT07719127":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":44,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":96,"locations":99,"central_contacts":115,"overall_officials":117,"references":120,"see_also_links":121},"NCT07719127","CASE7326","Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High Grade Glioma","A Window-of-Opportunity Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High-Grade Glioma","NOT_YET_RECRUITING","2027-12-31","2026-07","2026-07-22","2026-10","Case Comprehensive Cancer Center","OTHER",true,"This research study is for participants with glioblastoma. It can cause a tumor immunosuppression which helps myeloid cells that can stop T-cell function. Disulfiram is a drug that has been used in treating other disorders, but this study will examine if disulfiram can help make the tumor environment less immunosuppressive and reduce brain swelling when taken before surgery.","Glioblastoma is one of the most common brain cancers that affect adults and is very hard to treat. This is due to myeloid cells, which are special immune cells in the body that prevent the body from recognizing and attacking the tumor. Because of this, immunotherapies have not worked well in treating glioblastoma.\n\nDisulfiram may also reduce brain swelling, which may decrease or delay the need for subjects to be treated with steroids.\n\nThe purpose of this study is to find out if disulfiram can help reduce immunosuppression and help prevent edema symptoms when taken 3-14 days before planned surgery.",[19],"Brain (Nervous System) Cancers",[21],"brain and nervous system","INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Disulfiram (DSF)","250 milligrams (mg) disulfiram will be given daily for 3-14 prior to operation. Participants can have the option to be treated at 500mg after initial evaluation.",[35],"Disulfiram",[37,41],{"measure":38,"description":39,"timeFrame":40},"Reduction in Complement Immunosuppressive program","Evaluate whether disulfiram given pre-operation reduces the Complement Immunosuppressive myeloid program scores vs historical controls, which will be compared using a two-sample Wilcoxon rank-sum test (primary) and a two-sample t-test on the participant-level program scores (sensitivity). Measured using scRNA-sequence data.","day 0, up to 14 days",{"measure":42,"description":43,"timeFrame":40},"Reduction in Scavenger Immunosuppressive program","Evaluate whether disulfiram given pre-operation reduces the Scavenger Immunosuppressive myeloid program scores vs historical controls, which will be compared using a two-sample Wilcoxon rank-sum test (primary) and a two-sample t-test on the participant-level program scores (sensitivity). Measured using scRNA-sequence data.",[45,49,53,56,59,62],{"measure":46,"description":47,"timeFrame":48},"Proportion of participants needing dexamethasone within 48 hour window","Change in investigator-rated edema symptom composite score from baseline to Day 2 on therapy.","48 hours",{"measure":50,"description":51,"timeFrame":52},"Safety of disulfiram","Safety is defined as the rates of adverse events experienced by participants. Adverse event severity is graded according to the NCI Common Terminology for Adverse Events (CTCAE) Version 5.0","14 days",{"measure":54,"description":55,"timeFrame":40},"Change in Edema Symptom Composite Score (ESCS)","Change in ESCS is analyzed using a Wilcoxon signed-rank test",{"measure":57,"description":58,"timeFrame":52},"Tolerability of disulfiram","Tolerability as measured by participant toxicity rates.",{"measure":60,"description":61,"timeFrame":40},"Change in Microglial Inflammatory program scores","Evaluate the change in microglial inflammatory program scores vs historical controls, which will be compared using a two-sample Wilcoxon rank-sum test (primary) and a two-sample t-test on the participant-level program scores (sensitivity). Measured using scRNA-sequence data.",{"measure":63,"description":64,"timeFrame":40},"Change in Systemic Inflammatory Program Scores","Evaluate the change in systemic inflammatory program scores vs historical controls, which will be compared using a two-sample Wilcoxon rank-sum test (primary) and a two-sample t-test on the participant-level program scores (sensitivity). Measured using scRNA-sequence data.","ALL","18 Years",null,false,{"inclusion":70,"exclusion":84,"raw_text":95},[71,72,73,74,75,76,77,78,79,80,81,81,82,83],"Age ≥18 years.","Radiographically suspected or confirmed high-grade glioma planned for surgical resection as part of standard clinical care.","Able to start disulfiram at least 3 days prior to planned surgery (treatment window 3-14 days pre-op).","In-patient status for the duration of study.","Karnofsky Performance Status (KPS) ≥70%.","Adequate organ function within 14 days prior to first dose:","ANC ≥1.5 x 10\\^9\u002FL","Platelets ≥100 x 10\\^9\u002FL","Hemoglobin ≥9 g\u002FdL","AST\u002FALT ≤2.5 x ULN","Total bilirubin ≤1.5 x ULN (unless Gilbert syndrome, in which case \\\u003C5 x ULN).","Ability to understand and willingness to sign written informed consent.","Willingness to avoid alcohol and alcohol-containing products during treatment and for 14 days after last dose.",[85,86,87,88,89,90,91,92,93,94],"Any dexamethasone (or other systemic glucocorticoid for cerebral edema) administered prior to enrollment\u002Ffirst dose (including outpatient or ED administration). This does not include inhalers or topical steroids.","Imaging features that are atypical for high-grade glioma that have reasonable concern for competing differential diagnoses (e.g. PCNSL, tumefactive MS, etc.)","Known hypersensitivity to disulfiram or thiuram derivatives.","Active or severe hepatic disease (e.g. hepatitis, cirrhosis, known liver disease that may be exacerbated by disulfiram), or baseline liver tests above inclusion thresholds.","Current use of metronidazole or other contraindicated interacting medications. See section 6.0; medication reconciliation for the list of medications\u002Ffoods.","Pregnant or breastfeeding. Pregnant women are excluded from the trial because the safety in pregnancy has not been established. Women who are breastfeeding are excluded from the trial because it is not known if disulfiram is present in breast milk.","Clinically unstable neurologic status requiring immediate steroid initiation, where delaying dexamethasone for a disulfiram trial would be unsafe (investigator judgment).","Any condition that would limit compliance with alcohol avoidance or study procedures, or that would make participation unsafe in investigator judgment.","Subjects receiving any other investigational agents.","Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled or unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Radiographically suspected or confirmed high-grade glioma planned for surgical resection as part of standard clinical care.\n* Able to start disulfiram at least 3 days prior to planned surgery (treatment window 3-14 days pre-op).\n* In-patient status for the duration of study.\n* Karnofsky Performance Status (KPS) ≥70%.\n* Adequate organ function within 14 days prior to first dose:\n\n  * ANC ≥1.5 x 10\\^9\u002FL\n  * Platelets ≥100 x 10\\^9\u002FL\n  * Hemoglobin ≥9 g\u002FdL\n  * AST\u002FALT ≤2.5 x ULN\n  * Total bilirubin ≤1.5 x ULN (unless Gilbert syndrome, in which case \\\u003C5 x ULN).\n* Total bilirubin ≤1.5 x ULN (unless Gilbert syndrome, in which case \\\u003C5 x ULN).\n* Ability to understand and willingness to sign written informed consent.\n* Willingness to avoid alcohol and alcohol-containing products during treatment and for 14 days after last dose.\n\nExclusion Criteria:\n\n* Any dexamethasone (or other systemic glucocorticoid for cerebral edema) administered prior to enrollment\u002Ffirst dose (including outpatient or ED administration). This does not include inhalers or topical steroids.\n* Imaging features that are atypical for high-grade glioma that have reasonable concern for competing differential diagnoses (e.g. PCNSL, tumefactive MS, etc.)\n* Known hypersensitivity to disulfiram or thiuram derivatives.\n* Active or severe hepatic disease (e.g. hepatitis, cirrhosis, known liver disease that may be exacerbated by disulfiram), or baseline liver tests above inclusion thresholds.\n* Current use of metronidazole or other contraindicated interacting medications. See section 6.0; medication reconciliation for the list of medications\u002Ffoods.\n* Pregnant or breastfeeding. Pregnant women are excluded from the trial because the safety in pregnancy has not been established. Women who are breastfeeding are excluded from the trial because it is not known if disulfiram is present in breast milk.\n* Clinically unstable neurologic status requiring immediate steroid initiation, where delaying dexamethasone for a disulfiram trial would be unsafe (investigator judgment).\n* Any condition that would limit compliance with alcohol avoidance or study procedures, or that would make participation unsafe in investigator judgment.\n* Subjects receiving any other investigational agents.\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled or unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":112},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106","United States",[107],{"name":108,"role":109,"phone":110,"email":111},"Tiffany Hodges, MD","CONTACT","216-286-7122","tiffany.hodges@uhhospitals.org",{"lat":113,"lon":114},41.4995,-81.69541,[116],{"name":108,"role":109,"phone":110,"email":111},[118],{"name":108,"affiliation":101,"role":119},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Malignant Glioma",[],{"nct_id":4,"found":15,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.","completed","Disulfiram for High-Grade Glioma Before Surgery","This research study is for people with high-grade glioma (a type of brain cancer) who are planning to have surgery. The study is looking at whether a drug called disulfiram (DSF) can make the tumor environment less able to suppress the immune system and reduce brain swelling. Disulfiram is given daily for 3 to 14 days before your operation. Researchers will measure changes in your immune system's response to the tumor during this time. The study aims to enroll 20 participants who are at least 18 years old and have a good performance status (Karnofsky Performance Status of 70% or higher).","The primary endpoints, which measure immune system changes, are assessed at day 0 and up to 14 days.",101,"You would take disulfiram daily for 3 to 14 days before your planned surgery. You would also need to be an in-patient for the duration of the study.","Not stated in the trial record.",[32],"v2"]