[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-glioma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,53,0,25,[9,41,85,128,149,174,211,242,268,309,345,365,384,414,439,461,489,515,536,571,591,610,637,660,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100487858","early-phase-1-multiparametic-metabolic-and-hypoxic-petmri-for-disease-assessment-in-high-grade-glioma-100487858",false,"NCT05632562","Multiparametic Metabolic and Hypoxic PET\u002FMRI for Disease Assessment in High Grade Glioma","Inclusion Criteria:\n\n1. Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and\u002For concurrent temozolomide (TMZ) with RT are allowed but not required.\n2. 10 years of age or older at the time of enrollment\n3. Able to undergo PET\u002FMRI without anesthesia or sedation. Minimal sedation with an anxiolytic such as alprazolam used routinely for SOC MRI is allowed.\n4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration of FET or FMISO.\n5. ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60.\n6. Life expectancy greater than 12 weeks.\n\nExclusion Criteria:\n\n1. Recurrent glioma\n2. Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study.\n3. Pregnancy or breast feeding\n4. Inability to complete PET\u002FMRI scans.\n5. Significant renal dysfunction (estimated GFR \\\u003C 30 mL\u002Fmin)\n6. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team\n7. Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET\u002FMRI studies.","ALL","10 Years","89 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) with O-(\\[2-\\[F-18\\]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-\\[F-18\\]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET\u002FMRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET\u002FMRI studies.",[27],"High Grade Glioma","RECRUITING","2026-08-17",{"date":31,"type":32},"2026-08-20","ACTUAL",{"date":34,"type":32},"2024-03-07",{"date":36,"type":21},"2028-02-01",{"name":38,"class":39},"University of Alabama at Birmingham","OTHER",2,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","18 Years","100 Years",{"count":51,"type":21},100,[53],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[56,57,58,59,27],"Melanoma","Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers",[61,62,63,64,65,56,66,67,68,69,70,57,71,72,73,74,27],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":76,"type":32},"2026-08-18",{"date":78,"type":32},"2018-01-26",{"date":80,"type":21},"2032-12-28",{"name":82,"class":83},"Novartis Pharmaceuticals","INDUSTRY",33,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":110,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":94,"type":21},124,[96],"PHASE1","The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[56,99,100,101,102,103,104,105,106,107,27,108,109],"Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[111,112,113,114,115,116,117],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","2026-08-13",{"date":120,"type":32},"2026-08-14",{"date":122,"type":32},"2022-11-30",{"date":124,"type":21},"2029-06-18",{"name":126,"class":83},"Pfizer",83,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100455569","mri-in-high-grade-glioma-patients-undergoing-chemoradiation-100455569","NCT05212272","MRI in High-Grade Glioma Patients Undergoing Chemoradiation","A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of high-grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme \\[GBM\\]).\n* ≥18 years of age.\n* ECOG performance status of 0 to 3\n* Anticipated to receive 6 weeks of chemoradiation\n\nExclusion Criteria:\n\n* Does not speak or read English\n* Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee.\n* Unable to give informed consent\n* Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor\n* Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan\n* Currently taking cognition-enhancing medications including:\n\n  * Donepezil\n  * Memantine\n  * Armodafinil\n  * Methylphenidate\n* Pregnant or nursing mothers.\n* Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion\u002Fexclusion criteria",{"count":136,"type":21},16,[138],"NA","The purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, optional lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.",[27],{"date":29,"type":32},{"date":143,"type":32},"2022-09-02",{"date":145,"type":21},"2027-12",{"name":147,"class":39},"Wake Forest University Health Sciences",1,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":148},"100482675","phase-1-prospective-surgical-study-on-the-pattern-of-electrical-activity-in-high-grade-glioma-as-a-predictor-of-progression-100482675","NCT05565118","Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression","Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma (WHO Grade III and IV) as a Predictor of Progression","Inclusion Criteria:\n\n* Participants who have the appearance of high-grade glioma (HGG, WHO Grade 3 and 4, including GBM) on MR imaging are allowed to consent and will undergo the procedure if the frozen is consistent with HGG\n\nOR\n\n* Participants with a history of histologically-confirmed diagnosis of high- grade glioma that are undergoing resection of a recurrent\u002Fprogressive tumor that is likely recurrent\u002Fprogressive high- grade glioma as identified on preoperative MR imaging\n* Age ≥ 18 years old\n* Volumetric MRI within 1 month prior to surgery\n* Karnofsky performance status of 60 or higher\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Participants must be considered appropriate neurosurgical candidates with the following screening\u002Fbaseline laboratory values within 1 month prior to surgery:\n\n  * Absolute neutrophil count ≥ 1500\u002FµL\n  * Platelets ≥ 100 000\u002FµL\n  * International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × Upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * Urine or Serum Pregnancy Test = Negative (Not applicable to participants with bilateral oophorectomy and\u002For hysterectomy or to those participants who are postmenopausal).\n\nExclusion Criteria:\n\n* Severe co-morbidity that would confer excess risk of surgery as determined by the treating physician.\n* Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.\n* Is pregnant\n* Coagulopathy or platelet dysfunction that increases the risk of intra and postoperative hemorrhage\n* Tumor location requiring DE placement\u002Fbiopsy in eloquent or critical region of the brain (e.g. primary motor and sensory cortices, speech and vision centers, thalamus, basal ganglia, cerebellum, brain stem) as deemed by the neurosurgeon designing the surgical plan",{"count":157,"type":21},10,[96],"The purpose of this study is to test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings.",[27,161],"Glioblastoma",[27,161,163,164],"Neural Recording","Electrical Activity","2026-08-04",{"date":167,"type":32},"2026-08-06",{"date":169,"type":32},"2024-04-09",{"date":171,"type":21},"2026-12",{"name":173,"class":39},"Case Comprehensive Cancer Center",{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":16,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":148},"100370165","phase-1-c7r-gd2car-t-cells-for-patients-with-gd2-expressing-brain-tumors-gail-b-100370165","NCT04099797","C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)","Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With GD2-expressing Brain Tumors (GAIL-B)","Procurement Inclusion Criteria:\n\nCohort 1:\n\n1. Histologically confirmed, GD2-expressing newly diagnosed DMG\u002FHGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.\n\n   OR\n\n   Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG\u002FHGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.\n\n   OR\n\n   Recurrent, refractory, or progressive high-grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma \"CNS embryonal tumors, AT\u002FRT, ependymal tumors, diffuse gliomas or glioneuronal tumors.\n\n   Cohort 2:\n\n   Recurrent, refractory, or progressive pontine HGG with confirmed GD2-expression or H3K27-altered DMG\n2. Tumors less than 5 cm in maximum dimension at enrollment\n\n   1. Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study\n   2. Tumors with \\>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared with pre-irradiation MRI.\n   3. Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked\n3. Measurable disease on at least 2 dimensions on MRI\n4. Age 12 months to 25 years\n5. Functional score (Karnofsky\u002FLansky) ≥ 50 expected at infusion (≥60 for cohort 2)\n\nProcurement Exclusion Criteria:\n\n1. Patients who are pregnant or breast feeding\n2. Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.\n\nTreatment Inclusion Criteria\n\nCohort 1:\n\n1. Histologically confirmed, GD2-expressing newly diagnosed DMG\u002FHGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.\n\n   OR\n\n   Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG\u002FHGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.\n\n   OR\n\n   Recurrent, refractory, or progressive high -grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma, CNS embryonal tumors, AT\u002FRT, ependymal tumors, diffuse gliomas, or glioneuronal tumors.\n\n   Cohort 2:\n\n   Recurrent, refractory, or progressive pontine H3K27-altered for DMG or HGG with confirmed GD2-expression.\n2. Tumors less than 5 cm in maximum dimension at enrollment\n\n   1. Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study\n   2. Tumors with \\>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared pre-irradiation MRI\n   3. Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked\n3. Measurable disease on at least 2 dimensions on MRI\n4. Central line (PICC or other) and Ommaya reservoir or VP shunt in place or planned to be placed. Central line\u002FPICC may be omitted for cycles that do not include lymphodepletion\n5. Age 12 months to 25 years\n6. Functional score (Karnofsky\u002FLansky) ≥ 50 (≥60 for cohort 2)\n7. Patients must have completed standard of care radiation therapy at least 4 weeks prior to administration of investigational agent. If bevacizumab was administered for management of radiation necrosis, therapy must be completed at least 4 weeks prior to administration of investigational agent.\n8. Stable neurologic exam for 7 days prior to enrollment\n9. Stable or decreasing dose of steroids (max. allowable dose of dexamethasone is 0.1 mg\u002Fkg\u002Fday over the past 7 days prior to infusion of investigational therapy)\n10. Organ function:\n\n    1. ANC \\> 1000 cells\u002Ful\n    2. Platelet count \\> 100,000 cells\u002Ful\n    3. Total bilirubin \\\u003C 1.5x ULN\n    4. ALT and AST \\\u003C 5x ULN\n    5. Serum creatinine or kidney within 2x ULN for age\n\nTreatment Exclusion Criteria\n\n1. Patients who received any other forms of immunotherapy ≤ 42 days before administration of investigational agent\n2. Patients who received colony-stimulating factors within 14 days prior to administration of lymphodepletion\n3. Patients receiving any concurrent anti-cancer therapy (treatment must occur at least three half-lives following prior anti-cancer therapy)\n4. Patients who are pregnant or breast feeding\n5. Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.","12 Months","25 Years",{"count":184,"type":21},56,[96],"In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare high-grade glioma that expresses GD2. Cohort 2 is for patients with a type of cancer called progressive diffuse intrinsic pontine glioma that expresses GD2.\n\nBecause there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that help the body fight infection.\n\nThis research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat cancer patients. They have shown promise but have not been strong enough to cure most patients.\n\nResearchers have found from previous research that they can put a new antibody gene into T cells that will make them recognize cancer cells and kill them. GD2 is a protein found on several different cancers. Researchers testing brain cancer cells found that many of these cancers also have GD2 on their surface.\n\nIn a study for neuroblastoma in children, a gene called a chimeric antigen receptor (CAR) was made from an antibody that recognizes GD2. This gene was put into the patients own T cells and given back to 11 patients. The cells did grow for a while but started to disappear from the blood after 2 weeks. The researchers think that if T cells are able to last longer they may have a better chance of killing tumor cells.\n\nIn this study, a new gene will be added to the GD2 T cells that can potentially cause the cells to live longer. T cells need substances called cytokines to survive. The gene C7R has been added that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.\n\nIn other studies using T cells researchers found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and it will allow the T cells to expand and stay longer in the body and potentially kill cancer cells more effectively.\n\nAfter treating 11 patients, the largest safe dose of GD2-CAR T cells given in the vein (IV) was determined. We are now combining an IV infusion with an infusion directly into the brain through the Ommaya reservoir or programmable VP shunt. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way.\n\nPatients will now be assigned to Cohort 1 and 2 based on their tumor type.\n\nThe GD2.C7R T cells are an investigational product not approved by the FDA.\n\nThe purpose of this study is to combine infusions into the vein in the first treatment cycle with infusions directly into the cerebrospinal fluid (CSF) in the brain (intracerebroventricularly) through the ommaya reservoir or programmable VP shunt for infusions cycles 2-24. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way, and additionally to evaluate how long they can be detected in the blood and CSF and what affect they have on brain cancer.",[188,27,189,190],"Diffuse Intrinsic Pontine Glioma","Embryonal Tumor","Ependymal Tumor",[192,193,194,195,196,99,197,198,199,200,201],"Gene Therapy","CAR T-cells","chimeric antigen receptor","Brain Cancer","Immunotherapy","Brain tumor","DIPG","ETMRs","Medulloepithelioma","Atypical teratoid\u002Frhabdoid tumors","2026-07-31",{"date":204,"type":32},"2026-08-03",{"date":206,"type":32},"2020-02-03",{"date":208,"type":21},"2041-02",{"name":210,"class":39},"Baylor College of Medicine",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":16,"minAge":181,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":223,"conditions":224,"keywords":230,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100608845","phase-2-study-of-tovorafenib-in-high-grade-glioma-and-diffuse-intrinsic-pontine-glioma-dipg-100608845","NCT07206849","Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)","A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway","Inclusion Criteria:\n\n* Patient must have previously enrolled on TarGeT-SCR.\n\n  1. Age Patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR.\n  2. Body Surface Area (BSA) Patients must have a BSA \\>0.3m2.\n  3. Diagnosis:\n\n     * Patients with a newly-diagnosed HGG, including DIPG, which harbor alterations in the MAPK pathway are eligible. All patients must have tumor tissue from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n     * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4 glioma.\n     * All other HGGs must be WHO Grade 3 or 4.\n  4. Disease Status\n\n     • Patients must be newly diagnosed and enroll and start treatment within 35 days of completion of radiotherapy.\n\n     • Measurable disease is not required. Patients without measurable disease are eligible.\n     * Patients with primary spinal tumors are eligible.\n     * Patients with secondary or radiation-induced HGG are eligible.\n  5. TarGeT-B Strata Definitions\n\n     Patients must be able to be assigned to one of the strata below:\n\n     • Stratum A: Patients with intracranial, localized, non-pontine, and non-thalamic HGG harboring a BRAFV600 mutation (who do not meet criteria for Strata B or C).\n     * Stratum B: Patients with DIPG\u002FDMG as defined in Section 4.1.3 OR patients with localized, non-pontine, non-thalamic HGG harboring a MAPK alteration not included in Stratum A (KIAA1549:BRAF fusion, KRAS\u002FNRAS, CRAF\u002FRAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.\n     * Stratum C: Patients with metastatic HGG (including metastatic DIPG\u002FDMG) harboring a MAPK alteration (BRAFV600, KIAA1549:BRAF fusion, KRAS\u002FNRAS, CRAF\u002FRAF1, other RAF mutation, or FGFR alteration).\n  6. Presence of at least one relevant actionable somatic alteration:\n\n     • MAPK pathway alteration(s): BRAFV600 mutation (Strata A or C)\n     * KIAA1549:BRAF fusion (Strata B or C)\n     * KRAS\u002FNRAS alteration (Strata B or C)\n     * CRAF\u002FRAF1 alteration (Strata B or C)\n     * other RAF mutations (Strata B or C)\n     * FGFR alteration (Strata B or C)\n  7. Performance Level:\n\n     Karnofsky ≥ 50 for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n  8. Prior Therapy for HGG:\n\n     o Surgery, radiation (RT), and\u002For dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible but discouraged for patients with DIPG\u002FDMG. No other prior anticancer therapy for HGG will be allowed.\n\n     o Radiation therapy requirements: Patients must have received photon or proton focal radiotherapy if enrolling on Stratum A or B. Patients must have received craniospinal irradiation if enrolling on Stratum C.\n\n     o Radiotherapy, delivered photon or proton beam, must have been administered at a standard dose, including:\n\n     o 54 Gy in 30 fractions for DIPG\n\n     o 54-59.4 Gy in 30-33 fractions for other HGG\n\n     o 45-54 Gy for primary spinal cord HGG\n\n     o And\u002For 36-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54-60 Gy for intracranial metastasis.\n\n     o Any variances in the radiotherapy dose within 10% of standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.\n\n     o Timing between diagnosis and start of RT: Patients must have started RT within 31 calendar days of initial diagnosis which is defined as the date of diagnostic biopsy or resection. If a patient underwent two upfront surgeries e.g., biopsy then resection or debulking, this is the date of the second surgery.\n     * Timing post-RT: Patients must enroll and start treatment on TarGeT-B no later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.\n  9. Organ Function Requirements\n* Adequate Bone Marrow Function Defined as:\n\n  • Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm3.\n\n  • Platelet count \\>= 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n\n  • Hemoglobin \\>8 g\u002FdL (may be transfused).\n* Adequate Renal Function Defined as:\n\nCreatinine clearance or radioisotope GFR \\> 70ml\u002Fmin\u002F1.73 m2 OR serum creatinine based on age\u002Fgender as follows:\n\nMaximum Serum Creatinine (mg\u002FdL) Age Male Female 1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n\n* 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n\n  * Adequate Liver Function Defined as:\n\n    * Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN).\n    * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 times the ULN.\n    * Serum albumin ≥ 2g\u002FdL.\n  * Adequate Cardiac Function Defined as:\n\n    • Left Ventricular Ejection fraction of ≥ 50% as measured by echocardiogram or multiple-gated acquisition (MUGA).\n    * QTc ≤ 450 msec (by Bazett formula).\n  * Adequate Neurologic Function Defined as:\n\n    * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled (see Appendix II).\n  * Normal Thyroid Function Defined as:\n\n    • Free throxine (T4) within institutional guidelines for normal range. It is acceptable for patient to be on thyroid supplementation as long as free T4 is within institutional guidelines for normal range prior to starting treatment.\n\n    10\\) Informed Consent All patients and\u002For their parents or legally authorized representatives must sign a written Informed Consent and Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding.\n2. Other Exclusion Criteria\n\n   • Patients with neurofibromatosis type 1 (NF-1) are not eligible for this study.\n\n   • Infection: Patients who have an uncontrolled infection are not eligible.\n\n   • Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n\n   • Patients with uncontrolled GI disease or other condition that could affect absorption or predispose participant to gastrointestinal ulceration are not eligible.\n3. Concomitant Medications • Corticosteroids: Patients receiving corticosteroids are eligible, but the use of corticosteroids must be reported.\n\n   • Investigational Agents\u002FDrugs: Patients who are currently receiving another investigational drug are not eligible. This includes targeted agents, monoclonal antibodies, herbal supplements, or other investigational agents other than tovorafenib.\n\n   • Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible with the exception of temozolomide given concurrently with radiotherapy.\n\n   • Anticonvulsants: Patients who are receiving enzyme-inducing anticonvulsants as listed in Appendix II, are not eligible.\n\n   • Patients who are receiving medications known to prolong QTc interval as listed in Appendix III are not eligible.\n\n   • As tovorafenib is a substrate of CYP2C8, patients should not take strong inhibitors or inducers of CYP2C8 (See Appendix VI), as they could alter the drug's pharmacokinetics. Medications that are substrates of CYP2C8 or CYP3A4 are allowed but should be used with caution.\n\n   • Medications that are substrates of breast cancer resistance protein (BCRP) with a narrow therapeutic index are prohibited during this study (Appendix IV).\n   * Patients who are receiving duloxetine, alosetron, or theophylline (CYP1A2 inhibitors) are not eligible.\n   * Patients on beta-blockers are not eligible.\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), Fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n   * Anticoagulants: patients who are receiving therapeutic anticoagulants including warfarin, low-molecular weight heparin are not eligible.\n\n5\\) Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.","39 Years",{"count":220,"type":21},79,[222],"PHASE2","The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets.\n\nThe main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.",[225,226,188,27,227,228,229],"High Grade Glioma (HGG) of the Brain With BRAF Aberration","High Grade Glioma (III or IV)","WHO Grade 3 Glioma","WHO Grade 4 Glioma","Metastatic Brain Tumor",[231,232],"tovorafenib","high grade glioma","NOT_YET_RECRUITING","2026-07-30",{"date":202,"type":32},{"date":237,"type":21},"2026-11",{"date":239,"type":21},"2037-11",{"name":241,"class":39},"Nationwide Children's Hospital",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":16,"minAge":249,"maxAge":182,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":258,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":40},"100564069","phase-1-atovaquone-combined-with-radiation-in-children-with-malignant-brain-tumors-100564069","NCT06624371","Atovaquone Combined With Radiation in Children With Malignant Brain Tumors","AflacBT2303","Inclusion Criteria:\n\n-Stratum 1\n\n* Newly diagnosed pHGG\u002FDMG\u002FDIPG Patients must have histologically confirmed pediatric high-grade glioma (pHGG, WHO Grade 3 or 4) or diffuse midline glioma with altered H3K27 (DMG, WHO Grade 4). Primary pHGG or DMG spinal tumors are eligible. Diffuse intrinsic pontine glioma (DIPG) defined by MRI does not require histological confirmation.\n* Weight \\> 10kg\n* Karnofsky and Lansky performance score \\> 50%\n* Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.\n* Adequate liver function defined as:\n\n  * Total bilirubin ≤ 2x upper limit of normal (ULN) and\n  * AST (SGOT) and ALT (SGPT) ≤ 225 U\u002FL (5x the ULN). The ULN for AST and ALT will be 45 U\u002FL.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\> 1,000\u002FmcL\n  * platelets \\> 100,000\u002FmcL\n  * hemoglobin \\> 8g\u002FdL\n  * Total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 5 x (\\\u003C10 x if taking steroids) the institutional upper limit of normal\n  * creatinine within normal institutional limits for age 2 OR\n  * creatinine clearance \\> 60mL\u002Fmin\u002F1.73 m for patients with creatinine levels above institutional normal\n\nStratum 2\n\n* Relapsed, progressive pHGG\u002FDMG\u002FDIPG and medulloblastoma (MB) or pHGG\u002FDMG\u002FDIPG after completion of standard radiation therapy without prior atovaquone exposure and before progression. Patients with metastatic disease are allowed for Stratum 2 only.\n\n  --Measurable disease is not necessary for enrollment study.\n* Patients must have previously undergone standard-of-care treatment including surgery, radiation, and\u002For first-line adjuvant chemotherapy before the experimental treatment (atovaquone).\n* Patients must have recovered from the acute treatment-related toxicities (defined as \\\u003C grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study. There is no upper limit to the number of prior therapies that is allowed.\n* Age \\> 2 to 25 years\n* Weight \\> 10kg\n* Karnofsky and Lansky performance score \\> 50%\n* Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.\n* Patients must have normal organ and marrow function as defined above for Stratum 1\n* Adequate liver function is defined as:\n\n  1. Total bilirubin ≤ 2x upper limit of normal (ULN) and\n  2. AST (SGOT) and ALT (SGPT) ≤ 225 U\u002FL (5x the ULN). The ULN for AST and ALT will be 45 U\u002FL.\n\nExclusion Criteria:\n\nStratum 1\n\n* Chronic systemic concurrent illness\n* Concurrent or history of anti-cancer therapy other than RT\n* Patients with metastatic tumor are excluded for Stratum 1 only.\n* Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.\n* Patients must fully recover from all acute effects of prior surgical intervention.\n* History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.\n* Symptomatic intratumoral hemorrhage, or asymptomatic intratumoral hemorrhage larger than punctate foci, at any time prior to enrollment.\n* Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion.\n\nStratum 2\n\n* Concurrent illness\n* Patients must have recovered from all prior therapy as follows:\n\n  1. Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks before study enrollment or at least six (6) weeks if prior nitrosourea.\n  2. Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent ≥ 7 days before study enrollment.\n  3. Antibodies: ≥ 21 days must have elapsed from an infusion of the last dose of antibody and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1. Agents with prolonged half-lives: At least three half-lives must have elapsed before enrollment.\n  4. Immunotherapy: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses. etc.) at least 42 days before enrollment.\n  5. Radiation: Patients must have had their last fraction of • Craniospinal irradiation ≥ 3 months before enrollment. • Other substantial bone marrow irradiation ≥ 6 weeks before enrollment • Local or palliative XRT (small port) ≥ 2 weeks.\n  6. Stem Cell Transplant: Patient must be ≥ 12 weeks since autologous bone marrow\u002Fstem cell transplant before enrollment. Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.\n* Patients must fully recover from all acute effects of prior surgical intervention.\n* History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.\n* Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion.","2 Years",{"count":251,"type":21},18,[96],"The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma\u002Fdiffuse midline glioma\u002Fdiffuse intrinsic pontine glioma (pHGG\u002FDMG\u002FDIPG).\n\nThe secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG\u002FDMG\u002FDIPG and medulloblastoma (MB) or pHGG\u002FDMG\u002FDIPG after completion of RT and before progression.",[255,256,188,257],"High-grade Glioma","Medulloblastoma","Diffuse Midline Glioma, H3 K27M-Mutant",[259,260],"Atovaquone","Progression-free survival",{"date":204,"type":32},{"date":263,"type":32},"2025-03-28",{"date":265,"type":21},"2027-10",{"name":267,"class":39},"Emory University",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":293,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":148},"100624942","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100624942","NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo surgical intervention for brain biopsy and\u002For resection.\n\n  * Initial diagnostic biopsy under 03-N-0164 will be performed to confirm recurrent disease and obtain pre-treatment tissue.\n  * The surgical intervention may include stereotactic\u002Fneedle biopsy, open biopsy, and\u002For resection, as determined by neurosurgical assessment. Only participants for whom gross total resection of tumor is not expected to be achievable will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","99 Years",{"count":277,"type":21},40,[96,222],"Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a \"port\" under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[281,282,283,284,285,286,287,99,288,289,290,291,27,292,195],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","Glioma, Malignant",[281,99,294,295,296,297,298,299,195],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","2026-07-29",{"date":234,"type":32},{"date":303,"type":32},"2026-07-15",{"date":305,"type":21},"2032-12-31",{"name":307,"class":308},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":16,"minAge":316,"maxAge":218,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":332,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100460636","phase-1-lutathera-for-treatment-of-recurrent-or-progressive-high-grade-cns-tumors-100460636","NCT05278208","Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors","Phase I\u002FII Study of Lutathera in Patients With Recurrent and\u002For Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET","All participants must meet the following inclusion and exclusion criteria. No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical evaluations to establish eligibility (except for \\[68Ga\\]Ga-DOTATATE PET) must be done within 7 days prior to enrollment.\n\n1. Screening Criteria\n\n   1.1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (any histologic grade) that is recurrent, progressive, or refractory. Note that patients with DIPG (based on radiographic\u002Fclinical diagnosis) who have undergone biopsy will be eligible with histologic diagnosis of grade II-IV infiltrating glioma. All tumors must have histologic verification either at the time of diagnosis or recurrence, except for patients meningioma who have not previously undergone biopsy or resection.\n\n   Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n\n   1.2 Prior Therapy Patients must have recurred\u002Fprogressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.\n\n   1.3 Screening Consent Participant\u002Flegal guardian is willing to sign a screening consent for \\[68Ga\\]Ga-DOTATATE PET imaging. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n2. Eligibility Criteria\n\n   * Phase I Age Patient must be ≥ 4 and \\\u003C12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.\n   * Phase II Age Patient must be 12 to \\\u003C\u002F=39 years at the time of enrollment.\n3. Inclusion Criteria\n\n   3.1 Uptake on \\[68Ga\\]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET\u002FCT in at least one tumor lesion (corresponding to known disease) equivalent to a Krenning score ≥2 (confirmed by central radiology review).\n\n   3.2 Prior Therapy Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy, or any other treatment modality prior to entering this study.\n\n   3.3 Chemotherapy Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.\n\n   3.4 Investigational\u002FBiologic Agent\n\n   ●Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.\n\n   For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n\n   ●Monoclonal Antibodies and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment.\n\n   3.5 Radiation\n\n   Patients must have had their last fraction of:\n   * Craniospinal irradiation or total body irradiation or radiation to \\> 50% of pelvis \\> 3 months prior to enrollment.\n   * Focal irradiation \\> 4 weeks prior to enrollment\n\n   3.6 Stem Cell Transplant\n\n   Patient must be:\n   * ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease\n   * ≥ 3 months since autologous stem cell transplant prior to enrollment\n\n   3.7 Growth Factors Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g. filgrastim, sargramostim or erythropoietin). Two weeks must have elapsed if patients received long-acting formulations.\n\n   3.8 Thrombopoietin receptor agonist\n   * Phase I: Patients must be off thrombopoietin receptor agonists for at least 1 week prior to enrollment (e.g. romiplostim, eltrombopag)\n   * Phase II: Patients can receive concurrent thrombopoietin receptor agonists\n\n   3.9 Somatostatin analogs Patients must be off long-acting somatostatin analogs for at least 4 weeks and off short-acting somastatin analogs (i.e., octreotide) for at least 24 hours.\n\n   3.10 Neurologic Status\n   * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.\n   * Patients with seizure disorders may be enrolled if seizures are well controlled.\n\n   3.11 Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within two weeks of enrollment must be ≥ 50. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\n   3.12 Organ Function\n\n   Patients must have adequate organ and marrow function, for eligibility and enrollment, as defined below:\n   * Adequate Bone Marrow Function as defined as:\n\n     * Absolute neutrophil count ≥ 1.0 x 109 cells\u002F L\n     * Platelets ≥100 x 109 cells\u002F L (unsupported, defined as no platelet transfusion within 7 days)\n     * Hemoglobin ≥8 g\u002Fdl (may receive transfusions)\n   * Adequate Renal Function as defined as:\n\n     * Creatinine clearance or radioisotope GFR \\>70mL\u002Fmin\u002F1.73m2 OR\n     * A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows:\n\n       1 to \\\u003C 2 years: maximum serum creatinine 0.6 mg\u002FdL for males and females. 2 to \\\u003C 6 years: maximum serum creatinine 0.8 mg\u002FdL for males and females. 6 to \\\u003C 10 years: maximum serum creatinine 1.0 mg\u002FdL for males and females. 10 to \\\u003C 13 years: maximum serum creatinine 1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years: maximum serum creatinine 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n       ≥ 16 years: maximum serum creatinine 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n   * Adequate Liver Function as defined as:\n\n     * Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age\n     * AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional ULN\n     * Serum albumin ≥ 2g\u002FdL\n     * Coagulation parameters: INR \\\u003C1.5 times ULN and aPTT \\\u003C1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters\n   * Adequate Cardiac Function as defined as:\n\n     * Ejection fraction of ≥ 55% by echocardiogram\n     * Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)\n\n   3.13 Corticosteroids Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment, with a maximum dexamethasone dose of 2.5mg\u002Fm2\u002Fday.\n\n   3.14 Pregnancy Status Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   3.15 Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for at least 7 months after drug cessation in females of childbearing potential and for at least 4 months after drug cessation in males of child fathering potential.\n\n   3.16 Informed Consent The patient or parent\u002Fguardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines.\n4. Exclusion Criteria\n\n   4.1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible.\n\n   4.2 Presence of bulky disease Patients with bulky disease on imaging as described below are ineligible. Treating physicians are encouraged to request a rapid central imaging review to confirm fulfillment of these criteria if there are questions or concerns.\n\n   Bulky disease is defined as:\n   * Tumor with evidence of clinically significant uncal herniation or midline shift.\n   * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR.\n   * Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine.\n\n   Note that patients with metastatic or multi-focal disease (with exception of bone marrow) are eligible as long as no sites of disease meet above criteria for bulky disease.\n\n   4.3 Breast-feeding Nursing mothers are excluded from this study. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Lutathera.\n\n   4.4 Concurrent Illness\n   * Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.\n   * Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n   * Patients with type I diabetes.\n\n   4.5 Concomitant Medications\n   * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n   * Prior or current treatment with 177Lu-DOTATATE\u002FTOC or 90Y-DOTATATE\u002FTOC.\n\n   4.6 Prisoners will be excluded from this study.\n\n   4.7 Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits, obtain follow-up studies required to assess toxicity to therapy, or adhere to drug administration plan, other study procedures, and study restrictions.\n5. Inclusion of Women and Minorities Both males and females of all races and ethnic groups are eligible for this study.","4 Years",{"count":318,"type":21},65,[96,222],"This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \\\u003C12 years (Phase I) or 12 to \\\u003C\u002F=39 years (Phase II) to test its safety and efficacy, respectively.\n\nFunding Source - FDA OOPD (grant number FD-R-0532-01)",[27,322,189,256,323,324,325,326,327,328,329,330,331],"Meningioma","Anaplastic Ependymoma","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Malignant Glioma","Recurrent Medulloblastoma","Recurrent Primary Central Nervous System Neoplasm","Refractory Diffuse Intrinsic Pontine Glioma","Refractory Malignant Glioma","Refractory Medulloblastoma","Refractory Primary Central Nervous System Neoplasm",[333,334,335],"Somatostatin Receptor","DOTATATE","Lutathera","2026-07-17",{"date":338,"type":32},"2026-07-20",{"date":340,"type":32},"2022-11-21",{"date":342,"type":21},"2033-11",{"name":241,"class":39},4,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100647750","phase-1-a-clinical-trial-evaluating-the-tolerability-safety-and-preliminary-efficacy-of-nrg-103-injection-in-patients-with-recurrent-or-progressive-high-grade-glioma-100647750","NCT07710690","A Clinical Trial Evaluating the Tolerability, Safety, and Preliminary Efficacy of NRG-103 Injection in Patients With Recurrent or Progressive High-grade Glioma","Inclusion Criteria:\n\n* Willing to voluntarily participate in the study, able to sign the Informed Consent Form (ICF), and willing to comply with the procedures specified in the study protocol.\n* Age ≥18 years, regardless of gender.\n* Participants must have a prior diagnosis of World Health Organization (WHO) Grade 3 or 4 glioma, according to the WHO (2021) classification criteria. A pathology report containing histopathological typing and necessary molecular pathology test results must be provided; this report will serve as sufficient histological documentation for study enrollment.\n* Patients must have exhausted standard anti-tumor therapies or be intolerant to standard treatments (including chemoradiotherapy, targeted therapy, or immunotherapy), as evidenced by the occurrence of Grade ≥3 non-hematologic toxicities or Grade 4 hematologic toxicities. There must be definitive evidence of recurrent or progressive glioma on magnetic resonance imaging (MRI) scans (assessed according to the RANO 2.0 criteria), with no recognized effective treatment options remaining. If MRI scans are inconclusive regarding tumor recurrence or progression, surgery\u002Fbiopsy is recommended; however, surgery\u002Fbiopsy is not required if the investigator determines that the combination of the imaging report and clinical manifestations is sufficient to indicate tumor recurrence or progression.\n\nExclusion Criteria:\n\n* Patients with known or suspected hypersensitivity to any components of the investigational medicinal product or to contrast agents.\n* Patients with contraindications to magnetic resonance imaging (MRI) scanning, including but not limited to: cardiac pacemakers, epicardial pacing leads, surgical and\u002For aneurysm clips, shrapnel, metal prostheses, potentially magnetically active implants, metallic foreign bodies in the eye, and non-removable metal dentures.\n* Patients with a history of prior gene therapy or oncolytic virus therapy.\n* Patients who have participated in other clinical trials and received other investigational drugs within 28 days prior to the first administration of NRG-103.\n\n  5, Patients who have received anti-tumor vaccines or other immunomodulatory agents (e.g., interferons, interleukin-2, thymosin, lentinan, etc.) within 4 weeks prior to enrollment. Patients who have received or are scheduled to receive live attenuated or recombinant vaccines within 4 weeks; or patients who have received or are scheduled to receive inactivated vaccines within 1 week.",{"count":352,"type":21},24,[96],"The primary objective of this study is to determine the safe dose range of NRG-103 in patients and to recommend the dosage for subsequent treatment, while also evaluating the preliminary efficacy and tolerability of the product.",[105,226,27],"2026-07-13",{"date":336,"type":32},{"date":359,"type":32},"2026-07-09",{"date":361,"type":21},"2030-04-30",{"name":363,"class":83},"Neuregen Therapeutics Co., Ltd.",3,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":380,"leadSponsor":382,"locationsCount":148},"100629293","phase-1-a-study-on-the-novel-oncolytic-virus-combined-with-pd-1-inhibitor-in-the-treatment-of-recurrent-high-grade-glioma-100629293","NCT07472790","A Study on the Novel Oncolytic Virus Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma","A Single-arm Clinical Study on the Efficacy and Safety of the Novel Oncolytic Virus Ad-TD-nsIL12 Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent for the study\n2. Be at least 18 years old from the date of signing the informed consent form\n3. Patients with high-grade glioma (HGG) who have recurred\u002Fprogressed after receiving standard treatment and confirmed to meet the 2021 edition of the World Health Organization (WHO) classification criteria for central nervous system tumors by histopathology\n4. According to the RANO 2.0 evaluation criteria, there is at least one measurable lesion, that is, the maximum vertical diameter of the lesion is ≥ 10mm\n5. No diagnosis of immunodeficiency\n6. Suitable for placement of Omaya capsule as judged by the investigator and eligible for intratumoral administration\n7. KPS score ≥ 50 points, predicted survival ≥ 2 months\n8. Organ function is good, as defined below:\n\n1\\) Blood routine (no blood transfusion or other treatment within 14 days): absolute neutrophil value ≥1.5×10\\^9\u002FL, platelet count ≥100×10\\^9\u002FL, hemoglobin ≥90g\u002FL, white blood cell count ≥3.0×10\\^9\u002FL; 2) Coagulation function: thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN), international normalized ratio (INR) ≤ 1.5 times ULN; 3) Liver function: total bilirubin (TBIL) ≤1.5 times ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; 4) Renal function: serum creatinine ≤1.5 times ULN, or creatinine clearance ≥ 50 mL\u002Fmin 9. Echocardiography shows normal cardiastolic function, left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion and severe arrhythmias 10. Participant has no active pulmonary infection 11. Participants are able to have gadolinium contrast enhanced scans 12. Participants and partners of childbearing potential and sexual activity must be willing to use a medically approved effective method of contraception, such as double-barrier contraception, during treatment and for 6 months after the last dose, and men agree not to donate sperm 13. Females of childbearing potential must have a negative blood pregnancy test result within 7 days prior to the first dose and are willing to undergo additional pregnancy testing during the study. Females of childbearing potential who have not been surgically sterilized (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or who are not postmenopausal; Menopause is the cessation of menstruation for 12 months in women over 45 years of age ≥ and excludes other causes of amenorrhea. In addition, serum follicle-stimulating hormone (FSH) levels in women under 50 years of age must be in the postmenopausal range to confirm menopause 14. Good compliance, willing and able to follow all research processes, and cooperate with observation and follow-up\n\nExclusion Criteria:\n\n1. Received treatment with any other unmarketed investigational drug within 4 weeks prior to the first dose\n2. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose, or need to undergo elective surgery during the study\n3. Those who have a history of cell therapy, gene therapy, or oncolytic virus treatment\n4. Patients who are unable to undergo magnetic resonance imaging (MRI) or single-photon emission computed tomography (SPECT) due to obesity or the presence of certain metals in the body, especially pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates\n5. Known psychiatric disorder or substance abuse that would interfere with cooperation with the requirements of the study\n6. Adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ grade 1 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.)\n7. Pregnant or breastfeeding women\n8. Presence of active hepatitis B or hepatitis C virus infection\n9. History of immunodeficiency, including HIV\u002FAIDS infection\n10. Patients with active infection or uncontrollable infection requiring intravenous systemic treatment, or unexplained fever \\>38.5°C during screening and before the first dose\n11. Allergy to immunotherapy and related drugs\n12. Patients with current heart disease or poorly controlled hypertension requiring treatment\n13. Patients with current unstable or active ulcers or gastrointestinal bleeding. 14. Patients with a history of organ transplantation or awaiting organ transplantation\n\n15\\. Severe coagulation disorders or other obvious evidence of bleeding risk; History of gastrointestinal bleeding; Any other bleeding event ≥ CTCAE2 level in the past 6 months 16. Participants who have received systemic steroid drugs (\\> 10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose; The following are excluded: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; Short-term use of corticosteroids for prophylaxis (e.g., for contrast allergy prevention) 17. History of severe cardiovascular disease, such as ventricular arrhythmias requiring clinical intervention; QTc interval\\> 480 ms; Acute coronary syndrome, congestive heart failure, stroke, or other grade III or above cardiovascular events within 6 months prior to the first dose; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) \\\u003C 50% 18. Other incurable malignancies within the past 3 years or at the same time, except for carcinoma in situ that is considered clinically curable, such as cervical cancer in situ and basal cell carcinoma of the skin 19. Participants have active or previously suffered autoimmune diseases with the possibility of recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroiditis 20. Individuals who have received live attenuated or recombinant vaccines within 4 weeks before the first administration, or inactivated vaccines within 2 weeks before the first administration 21. Individuals who have previously received immunotherapy and experienced irAE with a grade ≥3 22. Individuals with a history of encephalitis, multiple sclerosis, or other central nervous system infections 23. Individuals with cerebral herniation syndrome 24. Individuals deemed by the researchers to be unsuitable for participation in this clinical study for other reasons",{"count":373,"type":21},15,[96],"A single-arm clinical study on the efficacy and safety of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in the treatment of recurrent high-grade glioma",[255],{"date":378,"type":32},"2026-07-14",{"date":202,"type":21},{"date":381,"type":21},"2028-04-30",{"name":383,"class":83},"Beijing Bio-Targeting Therapeutics Technology Co., Ltd",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":16,"minAge":391,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":364},"100570871","phase-1-mapk-inhibition-combined-with-anti-pd1-therapy-for-braf-altered-pediatric-gliomas-100570871","NCT06712875","MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas","A Pilot Study Evaluating the Toxicity and Clinical Benefit of Mitogen-activated Protein Kinase (MAPK) Pathway Inhibition Combined With Programmed Cell Death-1 Checkpoint Blockade (Anti-PD1) for the Treatment of BRAF-altered Pediatric Gliomas","Inclusion Criteria:\n\nCohort A Only:\n\n* Patients with histologically confirmed diagnosis of pediatric high- or low-grade glioma harboring a KIAA1549-BRAF fusion: Low-grade glioma that is recurrent or progressive OR High-grade glioma that is newly diagnosed or recurrent OR\n* Patients with NF1-associated gliomas or NF1-altered glioma: Low-grade glioma that is recurrent or progressive OR High-grade glioma that is newly diagnosed or recurrent OR Transforming glioma that is newly diagnosed or recurrent\n\nCohort B Only:\n\n* Patients with histologically confirmed diagnosis of pediatric low-grade glioma harboring a BRAFV600 mutation that is recurrent or progressive OR\n* Patients with histologically confirmed diagnosis of non-brainstem pediatric high-grade glioma harboring BRAFV600 mutation that is newly diagnosed, recurrent, or progressive\n\nAll Cohorts:\n\n* Patients must be ≥1 and ≤26 years of age at the time of enrollment.\n* Patients must have a performance status of Karnofsky \\>50% for patients \\>16 years old and Lansky \\>50% for patients \\\u003C16 years old.\n* Patients must have adequate organ and bone marrow function\n* The effects of dabrafenib, trametinib, and nivolumab on the developing human fetus are unknown. For this reason, patients of childbearing potential (POCBP) and patients with sperm-producing reproductive capacity (PWSPRC) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent for the duration of study participation and for 30 days following completion of therapy. POCBP must have a negative pregnancy test.\n* Patients with neurological deficits that are stable for a minimum of 1 week prior to enrollment are eligible.\n\nNote: A baseline detailed neurological exam should clearly document the neurological status of the patient at the time of enrollment on the study.\n\n\\- Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment. Total dexamethasone dose at time of enrollment must be less than or equal to 2 mg\u002Fday total or 0.5 mg\u002Fkg\u002Fday, whichever is smaller.\n\nLGG Only\n\n* Patients must have received a prior BRAF inhibitor (first or second generation), MEK inhibitor, or a combination. The response to this therapy must be known and information provided at study enrollment.\n* Patients must have recovered from acute treatment-related toxicities (defined as \\\u003CGrade 1, excludes alopecia) prior to entering this study.\n\nHGG Only\n\n* Patients must have received prior radiotherapy \\>12 weeks prior to enrollment.\n* Patients must have recovered from acute treatment-related toxicities (defined as \\\u003CGrade 1, excludes alopecia) prior to entering this study.\n* NF1 patients with transforming gliomas and high-grade gliomas are eligible regardless of prior systemic therapy.\n* Patients who have received prior radiation therapy must have experienced progression post-radiation OR have measurable disease defined as residual tumor \\>1cm in at least one dimension\n\nExclusion Criteria:\n\n* Patients with disseminated disease.\n* Patients who have had prior radiation therapy \\\u003C12 weeks prior to registration.\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) (with the exception of alopecia).\n* Patients who receiving any other investigational agents. Note: There will be a 21-day washout period for all chemotherapeutic agents, a washout period of two half-lives for any targeted agents (e.g., MAPK inhibitors), and\u002For a washout period of 4 weeks for any antibody therapies (e.g., bevacizumab).\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biological composition to dabrafenib, trametinib, or nivolumab.\n* Patients who have received MAPK inhibitor and checkpoint blockade combination therapy.\n\nNote: Patients may have received MAPK inhibitor monotherapy or checkpoint blockade monotherapy.\n\n* Patients who previously discontinued BRAF inhibitor (type 1 inhibitor or dimer inhibitor, such as, DAY101), MEK inhibitor, or the combination because of grade 3 or higher toxicity or clinically significant grade 2 toxicity requiring discontinuation of therapy are not eligible.\n* Patients with the following:\n\n  * Known autoimmune disorders\n  * Immune disorders\n  * Immunodeficiencies\n* Patients with Crohn's disease, ulcerative colitis, or other inflammatory bowel disease.\n* Patients with active pancreatitis or history of pancreatitis within the last 3 months.\n* Patients with active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids.\n* Patients who have a known active Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection are ineligible. Patient must have documented evidence of negative tests for the presence of HIV, Hepatitis B surface antigen, and Hepatitis C (anti-HCV antibody OR Hep C RNA-qualitative).\n* Patients who have received a major surgical procedure ≤ 28 days of beginning study treatment, or minor surgical procedures (including VP shunt placement or stereotactic biopsy of the tumor) ≤ 7 days are not eligible.\n* Patients who are taking herbal preparations. These medications include but are not limited to St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Cannabis products of any type are not allowed throughout the study. Patients should stop using these herbal medications or cannabis products 7 days prior to enrollment.\n* Patients who are pregnant. Patients of childbearing potential must have a negative serum or urine pregnancy test. (If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.)\n* Patients who are lactating (unless they have agreed to not breastfeed). Breastfeeding patients are excluded from this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.\n* Patients with bulky tumor on imaging are ineligible. Bulky tumor is defined as:\n\n  * Tumor with any evidence of clinically significant uncal herniation or midline shift\n  * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR except for those patients with newly diagnosed HGG treated following irradiation without signs of tumor progression. For the latter group, a maximum diameter of contrast enhancing solid or necrotic tumor and of T2\u002FFLAIR abnormality will be 5 cm and 8 cm, respectively.\n  * Tumor that in the opinion of the site investigator, shows significant mass effect\n  * Metastatic disease: Patients with ≤ 5 separate foci of metastatic disease not causing mass effect on adjacent parenchyma and each measuring less than 0.5 cm in maximum diameter will be eligible for this arm of the study. Patients with leptomeningeal disease are eligible.\n  * Multi-focal disease (patients with multi-focal parenchymal disease will be eligible if the sum of the product of the maximum perpendicular diameters of all measurable non-contiguous lesions is less than 16 cm2 based on the T2\u002FFLAIR abnormality).","1 Year","26 Years",{"count":394,"type":21},27,[96,222],"Pediatric gliomas harboring BRAF-alterations, commonly BRAFV600 mutation or KIAA1549-BRAF fusion, are currently treated with either chemotherapy or mitogen activated protein kinase (MAPK) inhibitors, such as, dabrafenib and\u002For trametinib. Unfortunately, some BRAF-altered gliomas can progress or have rebound growth after discontinuation of therapy. Data from BRAFV600E-mutant melanoma has shown potential synergy between MAPK inhibition and anti-programmed cell death 1 (anti-PD1) checkpoint blockade. Anti-PD1 therapy, such as, nivolumab can block the PD1 receptor on T cells, a marker of T cell exhaustion, allowing a continued or more robust anti-tumor immune response. Here, investigators will combine MAPK inhibition with anti-PD1 therapy in recurrent, refractory low grade BRAF-altered glioma and newly diagnosed or recurrent BRAF-altered or NF-altered high grade glioma.",[107,27],[112,399,400,401,402,403,404,405,232],"BRAFV600","KIAA1549 BRAF fusion","nivolumab","dabrafenib","trametinib","MAPK inhibition combined with anti-PD1 immunotherapy","recurrent low grade glioma",{"date":407,"type":32},"2026-07-10",{"date":409,"type":32},"2025-04-01",{"date":411,"type":21},"2029-06",{"name":413,"class":39},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":16,"minAge":316,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":148},"100588843","phase-1-il-8-receptor-modified-cd70-car-t-cell-therapy-in-cd70-newly-diagnosed-and-recurrent-pediatric-high-grade-glioma-phgg-and-newly-diagnosed-diffuse-intrinsic-pontine-glioma-nddipg-100588843","NCT06946680","IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)","Peds IMPACT: Phase I Study -To Assess Safety and Feasibility of IL-8 Receptor Modified Patient-derived Activated CD70 CAR T Cell Therapy in Newly Diagnosed and Recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)","Peds IMPACT","Inclusion Criteria:\n\nAt enrollment:\n\n* Patients with a histologically confirmed diagnosis of:\n\n  * Newly diagnosed high-grade glioma (WHO Grade III or IV)\n  * Newly diagnosed DIPG (after first 2 HGG patients are treated)\n  * Recurrent or progressive high-grade glioma\n* Age 4-18 years old for ndHGG. Age 4-30 for rHGG. Age 4-30 for nd DIPG.\n* Patients with M+ disease without gliomatosis cerebri (see definition under exclusion criteria) ARE eligible.\n* Patients with primary spinal cord tumors ARE eligible.\n* CD70 positive (≥5%, 1+) The tumors from the surgical resection by immunohistochemistry will be confirmed by validated assay performed at UF Health Pathology, CLIA certified Lab.\n* CD70 tumor expression performed on paraffin-embedded tumor specimens will be evaluated. Tumor expression will be scored on a scale of 0 to 3 staining intensity:\n\n  0 = Negative\n  1. = Low level\n  2. = Moderate level\n  3. = High level The criteria for inclusion will be at least 5% of the cells scoring 1+ staining intensity (\\> 5%, 1+).\n* Karnofsky Performance Status (KPS, for patients \\>16yo) or Lansky Performance Score (LPS, for patients ≤16yo) of \\> 60% (Appendix C)\n* Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score provided the neurological deficit is stable.\n\nOrgan Function:\n\n* CBC with differential with adequate bone marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3.\n* Platelet count ≥ 75,000 cells\u002Fmm3. (Unsupported, no transfusion within 4 days.)\n* Hemoglobin ≥ 8 g\u002Fdl. (May receive transfusions)\n* Adequate renal function as defined below:\n* Serum creatinine \\\u003C 1.5 x institutional upper limit of normal for age and gender. Patients who do not meet the criteria but have a 24-hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 mL\u002Fmin\u002F1.73 m2 are eligible.\n* Adequate hepatic function as defined below:\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) for age\n* ALT ≤ 3 times institutional upper limits of normal for age\n* AST ≤ 3 times institutional upper limits of normal for age\n* Patients with neurological deficits should have deficits that are stable for a minimum of 7 days prior to enrollment.\n* Signed parental permission and, as appropriate, assent from pediatric patients age ≥14. If the patient's mental status precludes their informed consent, the legally authorized representative may give informed consent. Consent or permission\u002Fassent will be obtained at screening (before PBMC collection) and before treatment with CAR T-cells.\n* For females with childbearing potential, a negative serum pregnancy test at enrollment.\n* Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of the study drug.\n* Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of the study drug.\n* Prior Therapy for recurrent Cohort only:\n* Patients with recurrent or progressive disease must have received prior radiotherapy +\u002F- chemotherapy.\n* Patients must have recovered from the acute treatment related toxicities (≤ Grade 1) prior to enrollment.\n* Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment. Patients must have received their last dose of non-myelosuppressive chemotherapy at least 7 days prior to enrollment.\n* Patients must have received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment. Monoclonal antibody treatment and agents with known prolonged half-lives: Patient must have received their last dose of the agent ≥ 28 days prior to study enrollment.\n* Patients with recurrent or progressive HGG must have had their last fraction of:\n* Craniospinal irradiation, whole brain radiation, total body irradiation or radiation to spine ≥ 6 weeks (42 days) prior to enrollment.\n* Focal irradiation ≥ 14 days prior to enrollment.\n* ≥ 12 weeks (84 days) since autologous stem cell transplant prior to enrollment.\n* \\> 42 days since completion of any other type of adoptive cellular therapy prior to enrollment\n\nPrior to lymphodepletion and therapy:\n\n* Appropriate bridging therapy (radiation\u002Fre-irradiation and\u002For salvage chemotherapy, dependent on cohort) was initiated within 7 weeks of surgery RT or other protocol directed anti-cancer therapy is without significant toxicity that persisted over 4 weeks.\n* Early postoperative progression: Patients who progress during radiation treatment that are clinically stable and meet eligibility criteria prior to the start of lymphodepletion may continue on study. If these criteria are not met, these patients will be withdrawn from the study.\n* Neurologic Status\n* In patients with neurological deficits, deficits should be stable for a minimum of 7 days prior to the start of treatment. A baseline detailed neurological exam should clearly document the neurological status of the patient prior to the start of treatment.\n* In patients with seizure disorders, seizures must be well controlled prior to the start of treatment.\n* Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) (Appendix C) assessed within one week prior to the start of treatment must be ≥ 60%.\n* Organ Function Patients must have adequate organ and bone marrow function as defined in Section 3.1.\n* Pregnancy Testing Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Corticosteroids: A maximum dose of 0.75 mg\u002Fkg\u002Fday with maximum of 4mg\u002Fday.\n* No active infection: No fever exceeding 38.5 °C and no acute antibiotics, antiviral, or antifungal PO or IV therapy.\n\nExclusion Criteria:\n\n* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease-free for ≥ 3 years. (In situ cancer is permissible)\n* Spinal metastasis or gliomatosis cerebri. Gliomatosis cerebri - clear tumor involvement of multiple areas (\\>3 lobes), OR presence of clinical and\u002For radiographic evidence of impending herniation or spinal cord compression.\n* The patient is not a candidate for cellular therapy as assessed by the study bone marrow transplant physician.\n* Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.\n\nHIV-positive patients are ineligible due to the unknown safety and efficacy of infusing these patients with CAR T cells genetically modified using retroviral vectors. Additionally, the immunosuppression used for treatment in this study will pose an unacceptable risk.\n\n• Concurrent illness: Patients with active autoimmune disease, documented history of autoimmune disease\u002Fsyndrome, or any other condition that requires ongoing systemic steroids or systemic immunosuppressive agents, except\n\n* Patients with vitiligo or resolved asthma\u002Fatopy\n* Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome\n* Patients requiring physiologic doses of corticosteroids (up to 0.5 mg\u002Fm2\u002Fday dexamethasone equivalent)\n* History of or ongoing pneumonitis or significant interstitial lung disease.\n* Ongoing or active uncontrolled infection.\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator, would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n* Patients with any of the following cardiac diseases:\n* New York Heart Association (NYHA) functional class III or IV\n* Clinically significant cardiac arrhythmia including, but not limited to, Torsade de pointes or requiring a pacemaker\n* Left ventricular ejection fraction below 50% as determined by echocardiography (ECHO)\n* Pregnant or lactating women due to possible adverse effects on the developing fetus or infant.\n* Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n* Patients who have received the last vaccination of a live vaccine ≤ 30 days prior to enrollment are ineligible.\n* Patients who have received an inactivated virus, peptide, or mRNA vaccine within 14 days of the start of protocol therapy are ineligible.\n* Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity of therapy or to adhere to drug administration plan, other study procedures, and study restrictions.\n* Patients treated on any other therapeutic clinical protocols within 30 days prior to enrollment.\n* For females of childbearing potential, a negative serum pregnancy test at enrollment.","30 Years",{"count":352,"type":21},[96],"This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)",[255,188],[428,429,195,196,161],"CAR T Cell","Brain Tumor","2026-06-30",{"date":432,"type":32},"2026-07-01",{"date":434,"type":21},"2026-07",{"date":436,"type":21},"2045-12",{"name":438,"class":39},"University of Florida",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":148},"100609136","early-phase-1-window-trial-of-fluorescently-labeled-nivolumab-irdye800-nivo800-in-high-grade-glioma-hgg-100609136","NCT07210632","Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Patient must have imaging of highly suspicious high grade glioma (HGG)\n4. Patients for whom surgical craniotomy is planned as standard of care (SOC)\n5. Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) AST 9-80 (IU\u002FL) ALT 7-110 (IU\u002FL) BUN 6-50 (mg\u002FdL) Creatinine 0.5-3.0 (mg\u002FdL)\n\nExclusion Criteria:\n\n1. Patients not eligible for SOC surgical resection\n2. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n   Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n\n   Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n   Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n   Rash must cover \\\u003C 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\n   History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n6. Prior allogeneic stem cell or solid organ transplantation\n7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n8. Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n   Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n\n   Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n\n   Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n\n   Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n\n   Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment.\n10. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.",{"count":446,"type":21},38,[24],"High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.",[195,105,99,27,450,226,225],"High Grade Gliomas",[452,232],"hgg","2026-06-29",{"date":432,"type":32},{"date":456,"type":32},"2026-03-27",{"date":458,"type":21},"2031-03-30",{"name":460,"class":39},"Eben Rosenthal",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":468,"sex":16,"minAge":391,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":479,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":251},"100541748","early-phase-1-lorlatinib-for-newly-diagnosed-high-grade-glioma-with-ros-or-alk-fusion-100541748","NCT06333899","Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion","A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion","Inclusion Criteria:\n\n1. Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment on TarGeT-SCR.\n2. Diagnosis:\n\n   Patients with newly diagnosed high-grade glioma (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors harbor an ALK or ROS-1 fusion alteration are eligible. Patients must have had histologically verified high-grade glioma from diagnostic biopsy or resection. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4. All other HGGs must be Grade 3 or 4.\n3. Disease Status:\n\n   Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is intended to be given. MRI of spine must be performed if disseminated disease is suspected clinically by the treating physicians. Patients with primary spinal tumors are eligible only if the patient is to receive either chemotherapy or focal radiation therapy, i.e., no craniospinal RT is intended to be given. Patients with leptomeningeal disease only, with no definitive identifiable primary tumor, and documented ALK or ROS-1 fusion, must be discussed with the Study Chair on a case-by-case basis.\n4. Performance Level:\n\n   Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n5. Prior Therapy:\n\n   * Patients must not have received any prior anti-cancer chemotherapy.\n   * Prior use of corticosteroids is allowed (see below Exclusion Criteria)\n6. Organ Function Requirements 6.1 Adequate Bone Marrow Function Defined as:\n\n   * Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FμL\n   * Platelet count ≥ 100,000\u002FμL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n   * Hemoglobin \\>8 g\u002FdL (may receive transfusions) 6.2 Adequate Renal Function Defined as:\n   * Serum creatinine within normal institutional limits OR Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 6.3 Adequate Liver Function Defined as:\n   * Total bilirubin ≤ 2 × institutional upper limit of normal\n   * AST(aspartate aminotransferase)\u002FALT(alanine transaminase) ≤ 2.5 × institutional upper limit of normal 6.4 Adequate Pulmonary Function Defined as: Pulse oximetry \\> 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest).\n\n6.5Adequate Cardiac Function Defined as: QTc ≤ 470 msec (by Bazett formula) 6.6 Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n\n6.7 Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n\n   Females of reproductive potential must use an effective non-hormonal method of contraception, since lorlatinib can render hormonal contraceptives ineffective, during study treatment and for at least 6 months after the final dose. Males with female partners of reproductive potential must use effective contraception during treatment with lorlatinib and for 3 months after the final dose.\n2. Concomitant Medications\n\n   * Investigational Agents\u002FDrugs: Patients who have previously received or are currently receiving another investigational drug are not eligible.\n   * Anti-cancer Agents: Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible\n3. Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection.\n4. Patients who have received prior solid organ transplantation are not eligible.\n5. Patients must not have malabsorption syndrome or other condition affecting oral absorption.\n6. Patients must not be receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to treatment with loraltinib. Moderate inducers of CYP3A4 should be avoided\n7. Avoid concomitant use of lorlatinib with certain CYP3A substrates, for which minimal concentration changes may lead to serious therapeutic failures. If concomitant use is unavoidable, increase the CYP3A substrate dosage in accordance with approved product labeling.\n8. P-glycoprotein (P-gp) substrates: Lorlatinib is considered a moderate P-gp inducer. Co-administration of lorlatinib with P-gp substrates including but not limited to digoxin should be avoided as the concentration of these drugs may be reduced by lorlatinib.\n9. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.\n10. Patients with a known personal history of acute or chronic severe psychiatric disorders or current history of suicidal ideation and history of suicide attempt.",true,"21 Years",{"count":373,"type":21},[24],"The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.",[27,188,474,475,161,285,476,477,478],"Anaplastic Astrocytoma","Infant Type Hemispheric Glioma","WHO Grade III Glioma","WHO Grade IV Glioma","Diffuse Midline Glioma, H3K27-altered",[480,481,27,188],"ALK fusion","ROS fusion","2026-06-25",{"date":453,"type":32},{"date":485,"type":32},"2025-08-03",{"date":487,"type":21},"2035-06-01",{"name":241,"class":39},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":16,"minAge":316,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":504,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":40},"100406493","phase-1-a-study-of-rna-lipid-particle-rna-lp-vaccines-for-newly-diagnosed-pediatric-high-grade-gliomas-phgg-and-adult-glioblastoma-gbm-100406493","NCT04573140","A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)","A Phase I\u002FII Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM), and Recurrent\u002FProgressive Medulloblastoma (MB)","PNOC020","Stratum 1 (Adult GBM)\n\n* Age ≥ 21 years.\n* Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma, secondary GBM not eligible) that is MGMT low level or unmethylated.\n* The tumor must have a supratentorial component.\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Residual post-surgical disease burden ≤ 3 cm as defined by longest perpendicular diameter of tumor on post-operative MRI.\n* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.\n* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.\n* Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  * ANC (Absolute neutrophil count) ≥ 1,000µl (unsupported)\n  * Platelets ≥ 150\u002Fµl (unsupported for at least 7 days)\n  * Hemoglobin \\> 8 g\u002FdL\n* Renal:\n\n  * BUN ≤ 25 mg\u002Fdl\n  * Creatinine ≤ 1.7 mg\u002Fdl\n* Hepatic\n\n  * Bilirubin ≤ 2.0 mg\u002Fdl\n  * ALT ≤ 5 times institutional upper limits of normal for age\n  * AST ≤ 5 times institutional upper limits of normal for age\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations\n* Signed informed consent. If the patient's mental status precludes his\u002Fher giving informed consent, written informed consent may be given by the legally authorized representative.\n* For women of childbearing potential (WOCBP), negative serum\u002Furine pregnancy test at enrollment (test will be repeated within 72 hours prior to starting TMZ in Stratum 1 patients).\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Refer to Appendix F for definition of WOCBP and guidance on acceptable contraceptive methods.\n* Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n\nStratum 2 (Newly-diagnosed Pediatric HGG)\n\n* Age \\> 3 and ≤ 25 years.\n* Histologically confirmed WHO Grade III or IV malignant glioma\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Residual post-surgical disease burden ≤ 3 cm as defined by longest diameter of tumor on post-operative MRI.\n* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.\n* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.\n* Performance Score: Karnofsky ≥ 60 for participants \\> 16 years of age and Lansky ≥ 60 for participants \\\u003C 16 years of age assessed within 2 weeks prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  1. ANC (Absolute neutrophil count) ≥ 1,000\u002Fµl (unsupported)\n  2. Platelets ≥ 100\u002Fµl (unsupported for at least 7 days)\n  3. Hemoglobin \\> 8 g\u002FdL (may be supported)\n* Renal: Creatinine clearance or radioisotope GFR ≥ 70mL\u002Fmin\u002F1.73 m2 or acceptable serum creatinine based on age\u002Fgender\n* Hepatic:\n\n  1. Bilirubin ≤ 3 times upper limit of institutional normal for age.\n  2. SGPT (ALT) ≤ 5 times upper limit of institutional normal for age.\n  3. SGOT (AST) ≤ 5 times upper limit of institutional normal for age.\n* Participants who are receiving systemically-administered steroids must be on a stable or decreasing dose for \\>1 week prior to enrollment. The patient steroid dose should be no more than a dexamethasone-equivalent of 2.8 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy for management of pituitary\u002Fadrenal axis insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed.\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations.\n* A legal parent\u002Fguardian or patient must be able to understand and be willing to sign a written informed consent and assent document, as appropriate.\n* For women of childbearing potential (WOCBP), negative serum\u002Furine pregnancy test at enrollment\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Refer to Appendix F for definition of WOCBP and guidance on acceptable contraceptive methods.\n* Males of child-fathering potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n* Patients must be enrolled on PNOC COMP prior to enrollment on PNOC020 if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\nStratum 1 (Adult GBM)\n\n* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)\n* MGMT Methylated tumors\n* Gliomatosis Cerebri\n* Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.\n* Recurrent or multifocal malignant gliomas.\n* Metastatic or leptomeningeal disease\n* Residual post-surgical disease burden \\> 3 cm as defined by longest perpendicular diameter on MRI.\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Known active infection or immunosuppressive disease.\n* Participants who require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination.\n* Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region, other than TMZ prescribed during radiation for GBM (prior chemotherapy for a different cancer is allowable).\n* Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. Radiosurgery is not permitted.\n* Severe, active co-morbidity, defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization.\n  * Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of XRT\u002FTMZ.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT\u002FTMZ.\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n  * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n  * Patients with autoimmune disease requiring medical management with immunosuppressants.\n  * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.\n  * Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.\n  * Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n* Women of childbearing potential must not be pregnant or breast-feeding.\n* Prior history of brachial neuritis or Guillain-Barré syndrome.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations\n\nStratum 2 (Pediatric HGG)\n\n* Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+\n* Bulky disease, defined as:\n\n  * Tumor with evidence of clinically significant uncal herniation, midline shift, tonsillar herniation, or brainstem infiltration, or that shows significant mass effect in either brain or spine\n  * Tumor with extensive and diffuse multilobular involvement (\\>3 lobes)\n  * Tumor with extracranial disease\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Uncontrolled seizure disorder\n* History of myocarditis\n* Receipt of any live vaccine within 30 days prior to enrollment\n* Known active infection or immunosuppressive disease.\n* Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.\n* Severe or unstable concurrent medical conditions.\n* Women must not be pregnant or breast-feeding.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.",{"count":498,"type":21},28,[96],"The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD",[502,27,503],"Adult Glioblastoma","WHO Grade III or IV Malignant Glioma",[196,429,65,505,506,507],"newly diagnosed","clinical trial","Pediatric brain tumor","2026-06-23",{"date":482,"type":32},{"date":511,"type":32},"2021-12-13",{"date":513,"type":21},"2029-07-01",{"name":438,"class":39},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":148},"100548980","phase-1-starlite-for-unresectable-high-grade-gliomas-100548980","NCT06428045","STARLITE for Unresectable High-Grade Gliomas","Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study","STARLITE","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI.\n\n   a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1).\n3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.\n4. Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists.\n5. Preoperative Karnofsky score ≥ 70 (APPENDIX A).\n6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery.\n\n   1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3\n   2. Platelets ≥ 100,000 cells\u002Fmm3\n   3. Hemoglobin ≥ 9.0 g\u002FdL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.\n   4. Blood urea nitrogen (BUN) ≤ 35 mg\u002FdL and creatinine ≤ 1.9 mg\u002FdL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate \\> 50 mL per minute.\n   5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia.\n   6. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) \\\u003C1.4\n   7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).\n   8. Sodium level \\> 130 mg\u002FL. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.\n7. Patients must be able to understand and sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with human leukocyte antigen (HLA) HLA-B\\*5701 hypersensitivity (Section 10.1.6.7).\n2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).\n3. Patients with a previous history of HIV infection.\n4. Patients with uncontrolled hepatitis B or C infection.\n5. Patients who have received any surgical resection for this tumor.\n\n   a. Patients who have received an open biopsy for this disease are still eligible for participation.\n6. Patients who have received chemotherapy or radiation for this disease.\n7. Patients who are taking dofetilide (Section 4.10.1).\n8. Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10.\n9. Patients not eligible to obtain MRI with and without contrast.\n10. Recurrent HGG.\n11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.\n12. Fever within 48 hours of surgery (Temperature\\> 38.0°C).\n13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.\n14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.\n15. Pregnant women.\n16. Patients must be willing to use contraception as described in Section 4.11.\n17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.\n18. Prisoners.\n19. Adults unable to consent.",{"count":352,"type":21},[96],"The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.",[27],[528],"Unresectable High Grade Glioma","2026-06-22",{"date":482,"type":32},{"date":532,"type":32},"2025-04-15",{"date":361,"type":21},{"name":535,"class":39},"University of Miami",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":16,"minAge":543,"maxAge":218,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":20},"100528530","phase-2-study-of-olutasidenib-and-temozolomide-in-hgg-100528530","NCT06161974","Study of Olutasidenib and Temozolomide in HGG","Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations","Criteria TarGeT-D study strata definitions\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.\n* Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.\n* Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:\n   * Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma.\n   * All other HGG must be WHO Grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Primary spinal tumor: Patients with a primary spinal HGG are eligible.\n   * Patient must not have metastatic disease.\n2. Inclusion criteria for assignment to TarGeT-D, for all strata:\n\n2.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:\n\n* R132H, R132C, R132S, R132G or R132L.\n* Patients whose tumors harbor other alterations in addition to IDH1 mutation will potentially be eligible following consensus recommendation by the international multidisciplinary molecular screening committee.\n* Patients with IDH2 mutations are not eligible.\n* Patients with oligodendroglioma, IDH-mutant and 1p\u002F19q-codeleted are not eligible.\n\n2.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.\n\n2.3 Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n2.4 Prior Therapy 2.4.1 Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide administered concurrently with radiotherapy is permissible. Prior administration of bevacizumab is allowed, given at least 42-day washout period is completed prior to beginning treatment on TarGeT-D. No other prior anticancer therapy for HGG will be allowed.\n\n2.4.2 Radiation therapy requirements: RT, delivered via photon or proton beam, must have been administered at a standard dose including 54 Gy in 30 fractions for DIPG, 55-59.4 Gy in 30-33 fractions for other HGG or 45-54 Gy for primary spinal cord HGG. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Study Chair to confirm eligibility prior to study enrollment.\n\n2.4.3 Timing between diagnosis and start of RT: Patients must have started RT \\\u003C 42 calendar days of initial diagnosis defined as the date of diagnostic biopsy or resection; if a patient underwent two upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n\n* Patients in pre-maintenance phase must enroll and start treatment no later than 21 calendar days post-completion of RT.\n* Patients not in pre-maintenance phase must enroll and start treatment no later than 35 calendar days post-completion of RT.\n\n2.5 Organ Function Requirements 2.5.1 Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3.\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin \\> 8 g\u002FdL (may be transfused). 2.5.2 Adequate Renal Function Defined as\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on age\u002Fgender as follows: 10 to \\\u003C 13 yrs=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 yrs=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.5.3 Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 × institutional ULN.\n* AST(SGOT)\u002FALT(SGPT) \\\u003C 3 × institutional ULN.\n* Alkaline Phosphatase \\\u003C 3 × institutional ULN. 2.5.4 Adequate Neurologic Function Defined as:\n\n  * Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not a strong inducer or inhibitor of CYP3A4\u002F5.\n  * Patients must be able to swallow oral medications to be eligible for study enrollment.\n\n2.6. Informed consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy.\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD).\n   * Intra uterine hormone releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner.\n   * Sexual abstinence (avoiding heterosexual intercourse).\n   * The following contraceptive measures are NOT considered effective:\n\n     * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation.\n     * Male or female condom with or without spermicide.\n     * Cap, diaphragm, or sponge with spermicide.\n2. Using the following types of concomitant medications:\n\n   * Corticosteroids: Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.\n   * Anti-cancer Agents: Concurrent anti-cancer agents are not allowed with the exception of temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D.\n   * Anticonvulsants: Patients who are receiving enzyme inducing anticonvulsants that are strong inducers of CYP3A4\u002F5 are not eligible.\n   * Strong CYP3A4\u002F5 inducers: Patients who are receiving strong inducers of CYP3A4\u002F5 are not eligible. Strong inducers of CYP3A4\u002F5 should be avoided from 14 days prior to or 5 half-lives (whichever is longer) enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n3. Other Criteria\n\n   * Infection: Patients who have an uncontrolled infection are not eligible.\n   * Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n   * Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n   * Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history.\n   * Patients with prior or ongoing clinically significant illness, medical or psychiatric condition, that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.\n   * Patients with any prior solid organ transplant are not eligible.\n   * Patients with secondary\u002Fradiation-related HGG are not eligible.\n   * Patients with metastatic\u002Fdisseminated HGG who have received CSI are not eligible.","12 Years",{"count":545,"type":21},60,[222],"The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.\n\nThe main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.",[27,549,550,551,188,476,477,229,257,552,553,554,555,556,557,558,559,560,561],"Astrocytoma","Astrocytoma, Grade III","Astrocytoma, Grade IV","Thalamus Tumor","Spinal Tumor","IDH1 Mutation","IDH1 R132","IDH1 R132C","IDH1 R132H","IDH1 R132S","IDH1 R132G","IDH1 R132L","Oligodendroglioma","2026-06-10",{"date":564,"type":32},"2026-06-12",{"date":566,"type":32},"2025-02-01",{"date":568,"type":21},"2035-06",{"name":570,"class":83},"Rigel Pharmaceuticals",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":16,"minAge":543,"maxAge":218,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":4},"100642450","phase-2-study-of-relatlimab-and-nivolumab-opdualag-in-replication-repair-deficient-hgg-and-dipg-100642450","NCT07644312","Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG","Feasibility and Phase 2a Study of Relatlimab and Nivolumab (Opdualag™) in Adolescent and Young Adult Patients Newly Diagnosed With Replication Repair Deficient High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG)","Inclusion Criteria:\n\n* Patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR.\n* Within the United States, patients must weight ≥ 40 kg at the time of enrollment. For all other countries, patients must weight ≥ 30 kg at the time of enrollment.\n\nDiagnosis:\n\n* Patients with newly-diagnosed HGG, including DIPG, are eligible. All patients mut have histologic confirmation from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG must have been confirmed through TarGeT-SCR.\n* All HGGs must be WHO Grade 3 or 4. Note: WHO Grade 2 gliomas with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons are eligible.\n\nDisease Status:\n\n* Patients must be newly diagnosed.\n* Measurable disease is not required.\n* Patients with primary spinal tumors are eligible.\n* Patients should have no evidence of herniation or impending herniation, and no mass effect leading to severe midline shift.\n* Patients with prior malignancy are eligible.\n* Metastatic disease is excluded.\n* Disseminated or multifocal disease: discussion with Study Chairs is required. Patients with multifocal disease who received upfront CSI are not eligible.\n\nDemonstration of DNA replication repair deficiency (RRD) by fulfilling at least 2 of the following criteria:\n\n* Tumor mutational burden greater than or equal to 5 mutations\u002Fmegabase (Intermediate and high TMB)\n* Genetic diagnosis of germline Constitutional Mismatch Repair Deficiency (CMMRD), Lynch Syndrome, or Polymerase-Proofreading Deficiency (PPD)\n* Validated functional genomic assay (e.g. LOGIC) confirming mismatch repair (MMR) deficiency\n* Immunohistochemistry (IHC) demonstrating loss of protein expression of any of the 4 MMR genes\n\nPerformance Level: Karnofsky ≥ 50 for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age\n\nPrior Therapy for HGG:\n\n* Surgery, RT, and\u002For dexamethasone are permissible. Temozolomide administration is highly discouraged with concurrent RT, but permissible. Anti-VEGF treatment used for vasogenic edema or steroid weaning is permitted. No other prior anticancer therapy for HGG will be allowed. Anti-VEGF use is well-established to not impact outcomes in HGG and is not considered as oncologic treatment but rather as a supportive measure to minimize steroid use in this setting. Discussion with Study Chairs is highly recommended.\n* RT requirements: Patients must have received photon or proton focal RT and administered at a standard dose, including:\n* 54 Gy in 30 fractions for DIPG\n* 54-59.4 Gy in 30-33 fractions for other HGG\n* 45-54 Gy for primary spinal cord HGG Note: Variances in RT dose within 10% of standard doses listed above are acceptable.\n* Timing between diagnosis and start of RT: Patients must have started RT \\\u003C 42 calendar days from initial diagnosis.\n* Timing post-RT: The earliest patent can begin protocl treatment is 28 days post-completion of RT. It is recommended treatment should begin within 25 days, however patients must start treatment on TarGeT-F no later than 8 weeks post-completion of RT.\n\nOrgan Function Requirements:\n\n* ANC ≥ 1000\u002Fmm3\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin \\> 8g\u002FdL (may be transfused)\n* Creatinine clearance or radioisotope GFR≥ 70 mL\u002Fmin\u002F1.73 m2 OR serum creatinine based on age\u002Fgender as follows:\n\n  10 to \\\u003C 13 years: 1.2 mg\u002FdL for males and females 13 to \\\u003C 16 years: 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females\n  * 16 years: 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females\n* AST\u002FALT \\\u003C 3 times the ULN. For the purpose of this study, the ULN for ALT and AST is 45 U\u002FL.\n* Ejection fraction greater than or equal to 50% as measured by echocardiogram or multiple-gated acquisition\n* QTc ≤ 480 msec (by Bazett formula)\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n* TSH within institutional guidelines for normal range.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients are excluded.\n* Patients with uncontrolled infection.\n* Patients with bone marrow failure syndrome.\n* Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n* Inflammatory bowel disease\n* Moderate to severe pulmonary conditions defined by need for medical intervention and\u002For limiting activities of daily living or shortness of breath with limited exertion.\n* Personal history of pneumonitis.\n* Cardiac conditions.\n* Patients with a history of severe or life-threatening adverse dermatologic reactions such as SJS or toxic epidermal necrolysis, or other severe reactions that have been associated with prior immune checkpoint inhibitor therapy.\n* Active tuberculosis\n* Active autoimmune disease requiring systemic treatment in the past 2 years\n* Chronic HBV infections with active disease\n* Personal known history of HPC who have not completed curative antiviral treatment\n* Personal known history of HIV\n* Receipt of any organ transplantation\n* Treated with other malignancy within 1 year prior to enrollment with the exception of the following: curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and in situ cervical cancer.\n* Receipt of a live or live-attenuated vaccine within 4 weeks prior to enrollment\n* Previous treatment with relatlimab\n* Patients with ongoing or clinically significant illness, medical or psychiatric conditions that, in the investigator's opinion, could affect the safety of the participant, or could impair assessment of the study's results are not eligible.",{"count":579,"type":21},12,[222],"The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.",[27,188,227,228,583],"Replication Repair Deficient","2026-06-08",{"date":564,"type":32},{"date":587,"type":21},"2027-03-01",{"date":589,"type":21},"2038-03-01",{"name":241,"class":39},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":16,"minAge":181,"maxAge":218,"enrollmentInfo":598,"targetDuration":4,"studyType":600,"phases":4,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100503755","targeted-pediatric-high-grade-glioma-therapy-100503755","NCT05839379","Targeted Pediatric High-Grade Glioma Therapy","Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n1. Age: Patients must be ≥12 months and ≤39 years of age at the time of enrollment onto this screening protocol.\n2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. Diagnosis must have histologic confirmation from biopsy or resection. The diagnosis of HGG must have been confirmed by pathology review at the local site. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.\n3. Disease Status: There are no disease status requirements for enrollment.\n\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Patients with metastatic\u002Fdisseminated or multifocal disease or gliomatosis cerebri are eligible.\n   * Patients with a primary spinal tumor are eligible.\n   * Patients with secondary, radiation related HGG are eligible.\n4. Prior Therapy for HGG: Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide concurrent with radiation is permissible. Prior administration of avastin\u002Fbevacizumab is allowed (individual treatment arms have different washout period requirements, check individual arm eligibility). No other prior anticancer therapy for HGG will be allowed.\n\n   * Participants screening for assignment to TarGeT-L may not have received radiation.\n\n   Timing from surgery to start of RT: For patients who have started RT, radiation must have started \\\u003C42 days from definitive surgery or biopsy, however it is strongly recommended patients start RT within 31 days from definitive surgery (if patient had two surgeries, radiation must have started within 31 days from second surgery).\n5. Tumor Sample Availability OR results from previous molecular profiling\u002Ftargeted sequencing\n\n   * If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood, saliva, or buccal swab) must be submitted for comprehensive molecular screening at the time of screening enrollment.\n   * If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review.\n6. Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT (if relevant)\n\n   * Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT (if completing RT).\n   * Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT (if completing RT).\n   * Participants screening for TarGeT-L (lorlatinib) are eligible to enroll on TarGeT-SCR anytime between diagnosis and 31 days post definitive surgery (to allow time for molecular review).\n\nHowever, it is important to note the following:\n\n* For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT.\n* For treatment protocols that only include maintenance\u002Fadjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT\n\n  #SCREENING OPTIONS\n* OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories\n* OPTION2: Molecular screening through a national comprehensive tumor profiling program\n* OPTION3: Clinically validated targeted sequencing or focused profiling\n\nExclusion Criteria:\n\n-Tumors that do not meet HGG and DIPG diagnoses specified above",{"count":599,"type":21},350,"OBSERVATIONAL","The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.",[27,188,474,161,285,257,229,476,477],{"date":562,"type":32},{"date":605,"type":32},"2024-08-02",{"date":607,"type":21},"2034-08-28",{"name":241,"class":39},21,{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":622,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":148},"100514481","omental-tissue-autograft-in-human-recurrent-glioblastoma-multiforme-rgbm-100514481","NCT05979064","Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)","Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).\n2. Omental graft is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject intends to participate in another clinical trial.\n3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.\n10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.\n11. Subject who are unable to have an MRI scan for any reason.",{"count":157,"type":21},[138],"This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.",[99,292,161,285,621,290,195,27],"Glioblastoma Multiforme of Brain",[623,624,625,626,627],"blood brain barrier","omentum autograft","omental autograft","omentum","omental","2026-05-28",{"date":630,"type":32},"2026-06-01",{"date":632,"type":32},"2023-04-04",{"date":634,"type":21},"2028-04",{"name":636,"class":39},"Northwell Health",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":650,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":148},"100512623","surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-glioblastoma-100512623","NCT05954858","Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma","Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).\n2. TPFF and\u002For pericranial flap is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n3. Subject intends to participate in another clinical trial\n4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n5. Subject has an active infection requiring treatment.\n6. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n7. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n8. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n9. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":645,"type":21},32,[138],"This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.\n\nThe objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).",[292,161,285,649,27,290,195],"Glioblastoma Multiforme, Adult",[651,623,652,653],"tissue autograft","pedicled temporoparietal fascial","pericranial flap",{"date":630,"type":32},{"date":656,"type":32},"2023-06-29",{"date":658,"type":21},"2029-06-30",{"name":636,"class":39},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":16,"minAge":181,"maxAge":218,"enrollmentInfo":667,"targetDuration":4,"studyType":22,"phases":669,"briefSummary":670,"conditions":671,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":679,"locationsCount":20},"100504051","phase-2-study-of-ribociclib-and-everolimus-in-hgg-and-dipg-or-ribociclib-and-temozolomide-in-dhg-h3g34-mutant-100504051","NCT05843253","Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant","Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG\u002FDIPG Which Harbor Alterations of the Cell Cycle and\u002For PI3K\u002FmTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant","TarGeT-A study strata definitions Part1: Initial Feasibility Study for the combination of ribociclib PfOS formulation with everolimus: Enrollment on this cohort will be limited to patients aged \\\u003C21 years with primary intracranial localized HGG and DIPG\n\nPart 2\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata C-D)\n* Stratum B: Patients with DIPG\n* Stratum C: Patients with primary thalamic, spinal cord, and\u002For secondary\u002Fradiation-related HGG.\n* Stratum D: Patients with metastatic\u002Fdisseminated HGG, multifocal HGG, and\u002For gliomatosis cerebri who received CSI.\n\nStratum E\n\n* Stratum E: Patients with localized DHG, H3G34-mutant.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR. For the Part 1 Initial Feasibility Cohort (receiving ribociclib and everolimus) only: patients must be \\\u003C21 years of age at the time of enrollment on this protocol.\n\n   1.2) Diagnosis: patients with newly-diagnosed HGG, including DIPG are eligible. All patients must have histologic confirmation tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR:\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology, consistent with diffuse WHO grade 2-4 glioma\n   * All other HGGs must be WHO grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Patients without measurable disease are eligible.\n   * Patients with metastatic or multifocal disease or gliomatosis cerebri who received upfront CSI are eligible\n   * Patients with a primary spinal HGG are eligible\n   * Patients with secondary, radiation-related HGG are eligible.\n2. Inclusion criteria for assignment to TarGeT-A, for all strata:\n\n2.1) Presence of at least one relevant actionable somatic alteration, detailed here:\n\n* Pathogenic alterations presumed to cause activation of cell cycle:\n* Amplification of CDK4 or CDK6\n* Deletion of CDKN2A, CDKN2B, or CDKN2C\n* Amplification of CCND1 or CCND2\n* Pathogenic alterations presumed to cause activation of the PI3K\u002FmTOR pathway:\n* Deletion or mutation of PTEN\n* Mutation or amplification of PIK3CA\n* Mutation of PIK3R1\n* Deletion or mutation of TSC1 or TSC2\n* Patients with evidence of homozygous (biallelic) RB1 loss by sequencing are excluded from TarGeT-A\n* Patients whose tumors harbor other alterations suspected to activate the cell cycle and\u002For PI3K\u002FmTOR pathway could potentially also be eligible, but only following consensus recommendation by the international multidisciplinary molecular screening committee.\n* For Stratum E: H3G34 (R\u002FV) mutation\n\n2.2) Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of ag. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n2.3) Prior Therapy for HGG:\n\n* Surgery, RT, dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible. Avastin\u002Fbevacizumab use is permitted given the last dose was administered \\> 21 days prior to enrollment. No other prior anticancer therapy for HGG will be allowed.\n* Patients must have received photon or proton RT.\n* Patients must have started RT \\\u003C 42 calendar days from initial diagnosis defined as the date of diagnostic biopsy or resection. If a patient underwent 2 upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n* RT delivered via photon or proton beam, must have been administered at a standard dose including (54 Gy in 30 fractions for DIPG, 54-59.4 Gy in 30-33 fractions), 45 Gy-54 Gy for primary spinal disease, and\u002For 36 Gy-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54 Gy-60 Gy for intracranial metastasis. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.\n* Patients must enroll and start treatment No later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.\n\n2.4) Organ Function Requirements\n\n2.4.1) Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Hemoglobin \\>8 g\u002FdL (may be transfused)\n\n2.4.2) Adequate Renal Function Defined as:\n\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows: 1 to \\\u003C 2 years=0.6 mg\u002FdL for males and females; 2 to \\\u003C 6 years=0.8 mg\u002FdL for males and females; 6 to \\\u003C 10 years= 1.0 mg\u002FdL for males and females; 10 to \\\u003C 13 years=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.4.3) Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 times institutional upper limit of normal for age\n* AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional upper limit of normal\n* Serum albumin ≥ 2g\u002FdL\n\n2.4.4) Adequate Cardiac Function Defined as:\n\n* Ejection fraction of ≥ 50% by echocardiogram\n* QTc ≤ 450 msec (by Bazett formula)\n\n2.4.5) Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not strong inducers or inhibitors of CYP3A4\u002F5.\n\n2.4.6) Adequate Pulmonary Function Defined as: No evidence of dyspnea at rest, and a pulse oximetry \\>94% on room air if there is clinical indication for determination.\n\n2.5) Ability to take medications by mouth: For ribociclib and everolimus strata, patients must be able to take study medications by mouth as administration via NG\u002FNJ\u002FG tube is not allowed.\n\n2.6) Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\n2.7) Contraception: Male and female patients of childbearing potential must be willing to use a highly effective contraception method.\n\nExclusion Criteria\n\n1. Pregnant or Breast-Feeding Pregnant or breast-feeding women will not be entered on this study due to known potential risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use at least one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD)\n   * Intra Uterine hormone releasing system\n   * Bilateral tubal occlusion\n   * Vasectomized partner\n   * Sexual abstinence (avoiding having heterosexual intercourse) The following contraceptive measures are NOT considered effective\n   * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation\n   * Male or female condom with or without spermicide\n   * Cap, diaphragm or sponge with spermicide\n2. Concomitant Medications\n\n   * Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Patients who are currently receiving another investigational drug are not eligible.\n   * Patients who are currently receiving other anti-cancer agents are not eligible, with the exception of temozolomide given concurrently with RT only.\n   * Patients who are receiving enzyme inducing anticonvulsants that are strong inducers or inhibitors of CYP3A4\u002F5 are not eligible.\n   * Patients who are receiving strong inducers or inhibitors of CYP3A4\u002F5 are not eligible and should be avoided from 14 days prior to enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible.\n   * Patients who are receiving therapeutic anticoagulation with warfarin or other coumadin-derived anticoagulants are not eligible. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed as long as the patient has adequate coagulation defined as aPTT \\\u003C 1.5Xs ULN and INR \\\u003C 1.5.\n3. Patients who have an uncontrolled infection are not eligible.\n4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n5. Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n6. Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the subject, or could impair the assessment of study results are not eligible.",{"count":668,"type":21},120,[222],"The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K\u002FmTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant.\n\nThe main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG\u002FDIPG or DHG H3G34-mutant.",[27,188,474,161,285,257,229,476,477,672],"Diffuse Hemispheric Glioma, H3 G34-Mutant","2026-05-27",{"date":675,"type":32},"2026-05-29",{"date":677,"type":32},"2024-08-22",{"date":607,"type":21},{"name":241,"class":39},{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":687,"enrollmentInfo":688,"targetDuration":4,"studyType":22,"phases":689,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":148},"100536404","phase-2-db107-retroviral-replicating-vector-rrv-combined-with-db107-flucytosine-fc-in-patients-with-recurrent-glioblastoma-or-anaplastic-astrocytoma-100536404","NCT06264388","DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma","A Biomarker-Guided Phase 2 Study of DB107-RRV (Retroviral Replicating Vector) Combined With DB107-Flucytosine Extended-Release Tablets in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma","Inclusion Criteria:\n\n1. Patients 18-75 years old.\n2. Histologically proven HGG that have recurred\u002Fprogressed (first or second recurrence).\n3. Patients with unresectable or resectable HGG (AA or GBM) will be enrolled.\n4. Measurable disease on MRI as evidenced by 1 cm on two separate dimensions on MRI fluid attenuated inversion recovery (FLAIR) (non-enhancing) or contrast-enhancement.\n5. Last temozolomide dosage 4 weeks prior to surgery.\n6. Patients with prior radiation therapy are allowed, but histological tumor diagnosis of recurrent tumor must be confirmed according to the RANO criteria. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI. If first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.\n7. Presence of Denovo Genomic Marker 7 (DGM7) biomarker in blood.\n8. Laboratory values (Platelet count ≥ 80,000, hemoglobin \\[Hg\\] ≥10 g\u002FdL, absolute neutrophil count (ANC) \\> 1,500 cells\u002Fmm3, absolute lymphocyte count (ALC) \\> 500\u002Fmm3) and adequate liver function, total bilirubin\\\u003C 1.5 upper limit of normal (ULN), alanine transaminase (ALT) \\\u003C2.5 ULN. Estimated glomerular filtration rate (eGFR) should be \\> 50 mL\u002Fmin (Cockcroft Gault Formula). Patients with aspartate transaminase (AST) or ALT values \\>3 ULN and total bilirubin \\>1.5 mg\u002FdL will be excluded.\n9. Patients cannot be pregnant at the time of enrollment or during the study. Patients willing to use one (1) effective method of contraception in addition to barrier methods (condoms) from the time of signing the informed consent form until 12 months after receiving the last dose of DB107-RRV or until there is no evidence of DB107-RRV in their blood, whichever is longer.\n10. Karnofsky Performance Score (KPS) ≥ 70.\n11. Patient is able to consent and abide by protocol.\n\nExclusion Criteria:\n\n1. History of active other malignancy (other than non-melanoma skin cancers, cervical ductal carcinoma in situ or localized prostate cancer) within 5 years.\n2. Multifocal gliomas that cannot undergo stereotactic biopsy\u002Fadministration of DB107-RRV will be excluded. Patients with 3 or more intracranial recurrences will be excluded.\n3. Histologically confirmed oligodendroglioma or mixed gliomas.\n4. History of human immunodeficiency virus (HIV) infection or other forms of severe immunosuppression.\n5. Patients with impaired renal function (eGFR\\\u003C50 cc\u002Fmin).\n6. Patients with bone marrow depression, such as those with a hematological disease or who are being treated with radiation or drugs that depress bone marrow or individuals who have a history of treatment with drugs or radiation that depress bone marrow within 1 month of enrollment.\n7. The patient intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer \\\u003C 30 days from surgery.\n8. Allergy to 5-FC.\n9. Gastrointestinal diseases that prevent absorption of medications such as 5-FC.\n10. Pregnancy or patients who are actively breast-feeding.\n11. Recent use of cytosine arabinoside (\\\u003C 3 weeks).\n12. Recent treatment with bevacizumamab (\\\u003C 3 weeks).\n13. Recent treatment with temozolomide (\\\u003C4 weeks).\n14. History of bleeding diathesis or current anti-coagulant or anti-platelet usage, including nonsteroidal anti-inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery.\n15. Sustained dependence on systemic dexamethasone (\\>8 mg\u002Fday) one month prior to surgery.\n16. Severe systemic illnesses including cardiopulmonary dysfunction (New York Heart Association \\> Grade 2 congestive heart failure (CHF), uncontrolled arrhythmias, significant pulmonary disease \\> Grade 2 dyspnea) or other serious medical condition or social situations that in the judgement of the Investigator(s) would interfere or limit compliance with study requirements\u002Ftreatments.\n17. The patient has or had any active infection requiring systemic antibiotic, antifungal or antiviral therapy within the past 4 weeks.\n18. Current or active coronavirus disease (COVID-19) disease, positive quantitative polymerase chain reaction (qPCR) result.\n19. Patients with impaired decision-making capacity.\n20. Patients who are currently receiving investigational medications or medical device(s) within 4 weeks (or 5 half-lives of the investigational medication(s), whichever is shorter) prior to enrollment.\n21. Patients who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the patient's compliance or place the patient at higher risk of potential treatment complications.","75 Years",{"count":84,"type":21},[222],"The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent\u002Fprogressive, resectable or unresectable disease and increase the time that disease is controlled.",[27,474],"2026-05-26",{"date":628,"type":32},{"date":695,"type":32},"2024-05-01",{"date":697,"type":21},"2034-05-01",{"name":699,"class":39},"Ashish Shah"]