[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656910":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":38,"overallOfficials":52,"centralContacts":56,"locations":66,"responsibleParty":85,"collaborators":18,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":18,"eligibilityCriteria":92,"healthyVolunteers":89,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":18,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":18,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Inova Health Care Services","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma","The response is defined as a confirmed complete response (CR) or partial response (PR) defined by RANO 2.0. Response rate will be calculated as the number of observed response (PR or CR) divided by all treated subjects in the arm.","through study completion, an average of 6 months from start of treatment",[14],{"measure":15,"description":16,"timeFrame":17},"Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma","Adverse events will be reported for all patients who receive at least one dose of study medicine.","through end of study, average 9 months from start of treatment",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","This is a prospective clinical trial in two cohorts of patients, adults with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas.\n\nThe study evaluates the efficacy of valproic acid, irinotecan, and simvastatin in recurrent glioma by measuring response rate.\n\nThe study treatment is as follow: Study Treatment\n\n* 21-day cycles\n* D1 VPA 40mg\u002Fkg\u002Fdose PO BID and simvastatin at 40mg PO daily\n* D2 VPA 40mg\u002Fkg\u002Fdose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg\u002Fm2 IV\n* D3-21 Continuous simvastatin starting at 40mg daily PO",[27,35],{"label":28,"type":29,"description":30,"interventionNames":31},"Glioblastomas","EXPERIMENTAL","Day1 VPA 40mg\u002Fkg\u002Fdose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg\u002Fkg\u002Fdose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg\u002Fm2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO",[32,33,34],"Drug: Valproic Acid (VPA)","Drug: Irinotecan","Drug: Simvastatin",{"label":36,"type":29,"description":30,"interventionNames":37},"IDH mutated gliomas",[32,33,34],[39,44,48],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":18},"DRUG","Valproic Acid (VPA)","Day 1 40mg\u002Fkg\u002Fdose PO BID and simvastatin at 40mg PO daily",[28,36],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"Irinotecan","D2 irinotecan 180mg\u002Fm2 IV and VPA 40mg\u002Fkg\u002Fdose PO BID, simvastatin at 40mg PO daily",[28,36],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":18},"Simvastatin","Day3-21 Continuous simvastatin starting at 40mg daily PO",[28,36],[53],{"name":54,"affiliation":5,"role":55},"Adam Cohen, MD","PRINCIPAL_INVESTIGATOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":18,"email":61},"Keary Jane't","CONTACT","(571) 472-3173","keary.jane't@inova.org",{"name":63,"role":59,"phone":64,"phoneExt":18,"email":65},"Takada Harris","(571) 472-0618","takada.harris@inova.org",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Inova Schar Cancer","RECRUITING","Fairfax","Virginia","22031","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-77.30637,38.84622,{"lat":79,"lon":78},[82,84],{"name":58,"role":59,"phone":83,"phoneExt":18,"email":61},"571-472-3173",{"name":63,"role":59,"phone":64,"phoneExt":18,"email":65},{"type":86,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100656910","phase-2-vista-valproic-acid-irinotecan-and-simvastatin-for-recurrent-glioma-100656910",false,"NCT07831369","VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma","Inclusion Criteria:\n\n* Diagnosis of glioblastoma or IDH-mutated glioma by WHO 2021 classification\n* For glioblastoma, at least one prior treatment, which needs to include temozolomide and\u002For radiation\n* For IDH-mutated glioma, prior treatment with both radiation and alkylating chemotherapy\n* Evidence of progression by RANO 2.0 criteria on MRI within last four weeks\n* At least 1 enhancing measurable lesion\n\nExclusion Criteria:\n\n* Use of an enzyme-inducing antiepileptic or other strong inducer of CYP3A4\n* Prior treatment with irinotecan\n* Prior use of valproic acid within 2 months\n* Anticancer treatment within 4 weeks, 6 weeks if nitrosourea\n* Active bacterial or fungal infection requiring systemic treatment\n* Pregnancy\n* Known mitochondrial disease","ALL","18 Years","98 Years",{"count":97,"type":98},52,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","The goal of this clinical trial is to see if the combination of valproic acid, irinotecan, and simvastatin causes these tumors to stabilize or shrink, which is a sign that these combinations are effective against tumors in patients with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas",[104,105],"Glioblastoma","Astrocytoma, IDH-Mutant, Grade 4","2026-09-15",{"date":108,"type":109},"2026-09-21","ACTUAL",{"date":111,"type":109},"2026-09-04",{"date":113,"type":98},"2030-12-30",{"name":5,"class":6},1]