[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-intrinsic-pontine-glioma-dipg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-intrinsic-pontine-glioma-dipg":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100651985","phase-1-targeted-lsam-cisplatin-infusion-in-gliomas-evaluation-of-response-100651985",false,"NCT07767110","Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response","Phase 1\u002F2a Study to Determine the Safety of Intratumoral Infusion of Large Surface Area Microparticle (LSAM)-Cisplatin in Participants With Diffuse Midline Glioma (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG)","TIGER-1","Inclusion Criteria:\n\n* Aged 3 to ≤ 21 years.\n* Diagnosis of diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), based on characteristic magnetic resonance imaging (MRI) findings and\u002For histopathologic confirmation.\n* Prior radiation treatment must have included focal radiation therapy per institutional standard of care and must have been initiated within 6 weeks of diagnosis.\n* At least 4 weeks, but no more than 12 weeks, post-completion of radiotherapy treatment.\n* A standard of care post-radiation magnetic resonance imaging (MRI) performed 4 to 6 weeks after radiation therapy is required for confirmation of eligibility.\n* Performance status \\[Karnofsky Performance Scale or Lansky Performance Score\\] within 14 days of Day 1 ≥ 60.\n* Absence of other significant medical condition.\n* A legal parent\u002Fguardian and\u002For participant must be able to understand and be willing to sign a written informed consent and\u002For assent document, as appropriate.\n\nExclusion Criteria:\n\n* Untreated symptomatic hydrocephalus at the time of consent, has metastatic or disseminated disease, or leptomeningeal disease.\n* Magnetic resonance imaging (MRI) findings that preclude stereotactic procedure.\n* Intercurrent illnesses or conditions which preclude participation: active systemic infections, autoimmune disease requiring systemic immunomodulation, active or uncontrolled seizure disorder, central nervous system (CNS) vasculopathy or aneurysms, Grade ≥3 cardiac dysfunction, Fridericia-corrected QT interval (QTcF) ≥470 ms.\n* Abnormal organ function:\n\n  * Renal insufficiency: glomerular filtration rate (GFR) ≤ 60 mL\u002Fmin\u002F1.73m² (with Schwartz equation)\n  * Hepatic dysfunction: aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of liver metastases; or bilirubin ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of Gilbert disease\n  * Bone marrow suppression:\n\n    * absolute neutrophil count (ANC) \\\u003C 1,000\u002FμL\n    * platelets \\\u003C 100,000\u002FμL\n  * Coagulopathy or international normalized ratio (INR) \\> 1.5\n* Receiving any anticoagulants or antiplatelet drugs; any drugs known to cause ototoxicity and nephrotoxicity; receiving any other tumor-directed therapy.\n* Known allergy or hypersensitivity to the study agent (including cisplatin and diluent components).\n* Female participants of childbearing potential must not be pregnant or breast-feeding.","ALL","3 Years","21 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Open-label, dose-escalating, Phase 1\u002F2a trial of Large Surface Area Microparticle (LSAM)-Cisplatin to treat participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), via stereotactic infusion under intraoperative magnetic resonance imaging (MRI) guidance.",[29,30,31],"Diffuse Midline Glioma (DMG)","Diffuse Intrinsic Pontine Glioma (DIPG)","Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma",[33,34,35,36,37],"Diffuse Midline Glioma","Diffuse Intrinsic Pontine Glioma","H3 K27 Mutation","Pediatric Brain Tumor","Convection-enhanced delivery","NOT_YET_RECRUITING","2026-08-14",{"date":41,"type":42},"2026-08-18","ACTUAL",{"date":44,"type":22},"2026-12",{"date":46,"type":22},"2029-12",{"name":48,"class":49},"NanOlogy, LLC","INDUSTRY"]