[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-grade-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-grade-glioma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,43,86,115,144,170,195,221,247,268,292,347,370,391,429,453,485,511,537,556,581,603,632,654],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":20},"100626905","phase-1-a-study-to-assess-a-medicine-called-tovorafenib-in-japanese-children-and-young-adults-with-brain-tumours-100626905",false,"NCT07441707","A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours","A Phase I, Open-label, Single-arm, Multicentre Study to Evaluate the Safety and Pharmacokinetics of Tovorafenib in Japanese Paediatric Participants With BRAF-altered Recurrent or Progressive Low-grade Glioma","Inclusion Criteria\n\n* Participants must be 6 months to 25 years of age, inclusive, with at least two generations of Japanese ancestry at the time of signing the informed assent\u002Fconsent.\n* Participants must have relapsed or progressive low-grade glioma with a documented known activating BRAF alteration, including BRAF V600 mutations and KIAA1549:BRAF fusions, as identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments-certified or other similarly certified laboratories.\n* Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.\n* Participants must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.\n* Participants must have at least one evaluable and\u002For measurable lesion (imaging must be performed within 28 days of initiation of treatment) as defined by Response Assessment in Neuro-Oncology-high grade glioma criteria (T1 weighted lesion that can be reproducibly measured in at least two dimensions of at least 10 mm, visible on ≥2 axial slices that are preferably, at most, 5 mm apart with 0 mm skip).\n* Participants must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy\n* Chronic toxicities from prior anticancer therapy must be stable and at National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade ≤2; ongoing retinopathy must be ≤1.\n* Participants must have adequate hematologic, hepatic and renal function\n* Participants receiving steroids for tumour-associated symptoms must be on a stable dose (e.g. no initial\u002Floading dose, no increase or decrease) for 14 days prior to C1D1.\n* Participants must be able to swallow tablets or liquid or administer through gastric access via a feeding tube (12 Fr or greater).\n\nExclusion Criteria\n\n* Participant's tumour has an additional previously known or expected to be activating molecular alteration(s) (e.g. histone mutation, isocitrate dehydrogenase 1 and 2 mutations, fibroblast growth factor receptor mutations or fusions, MYBL v-myb avian myeloblastosis viral oncogene homolog-like alterations, neurofibromatosis type-1 somatic or germline mutations).\n* Participant has symptoms of clinical progression without radiographically recurrent or radiographically progressive disease.\n* Participant has known or suspected diagnosis of neurofibromatosis type 1 via genetic testing or current diagnostic criteria.\n* Participant has history of any major disease (e.g. confirmed or suspected diagnosis of interstitial lung disease), other than the primary malignancy under study, that in the opinion of the investigator might interfere with safe protocol participation.\n* Participant has a history or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO), or ophthalmopathy present at baseline that would be considered a risk factor for CSR or RVO. Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) will NOT be considered significant abnormalities for the purposes of this study.\n* Participant has major surgery within 14 days (2 weeks) prior to Cycle 1 Day 1 (does not include central venous access, cyst fenestration or cyst drainage, or ventriculoperitoneal shunt placement or revision).\n* Participant has clinically significant active cardiovascular disease, history of myocardial infarction, deep vein thrombosis\u002Fpulmonary embolism within 6 months prior to C1D1, ongoing cardiomyopathy or current prolonged QT interval corrected for heart rate by Fridericia's formula interval \\>470 milliseconds based on triplicate electrocardiogram (ECG) average.\n* Participant has nausea and vomiting NCI-CTCAE v5.0 Grade ≥2, malabsorption requiring supplementation or significant bowel or stomach resection that would preclude adequate absorption of tovorafenib.\n* Participant is neurologically unstable despite adequate treatment (e.g. uncontrolled seizures).\n* Concomitant medications that are strong inhibitors or inducers of CYP2C8 within 14 days before initiation of therapy. Concomitant medications that are substrates of breast cancer resistance protein (BCRP) with a narrow therapeutic index within 14 days before initiation of therapy.\n* Participant has any clinically significant skin toxicity at Screening that in the opinion of the investigator would increase risk of severe skin toxicity when using investigational product.","ALL","6 Months","25 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate safety and the way the body absorbs, distributes and gets rid of the study drug tovorafenib in the body in Japanese children, adolescents and young adults with specific brain tumours. This includes how the drug is absorbed, distributed and eliminated from the body (called pharmacokinetics). The study will also test how well the drug works to shrink brain tumours.\n\nIn this study, all participants will receive tovorafenib orally once weekly.\n\nThere will be four periods in this study:\n\n1. Screening period (up to 4 weeks): Participants will be evaluated to determine if they can take part in the study, requiring at least one visit to the study centre.\n2. Treatment period (up to 24 months): All eligible participants will receive tovorafenib.\n\n   This requires five visits for the first 2 months (Cycle 1 and Cycle 2) followed by one visit every month (at the start of each treatment cycle). Participants will receive the first oral dose of tovorafenib on Day 1 of Cycle 1 at the study clinic. After Day 1, participants will need to take tovorafenib once weekly on Day 8, Day 15 and Day 22. Participants will be required to come to the study clinic in person at least five times for Cycle 1 and Cycle 2.\n\n   In addition, participants will have one remote visit (telephone call) during Cycle 1. After Cycle 2, only one in-person clinic visit is required at the start of each treatment cycle. A participant will stop treatment if their disease gets worse, if treatment has a harmful effect, or if they do not want to take part in the study anymore.\n3. End-of-Treatment Safety Follow-Up (30 days): Participants will have a clinic visit 30 days after stopping treatment to check their health.\n4. Long-Term Follow-Up (up to 2 years): Participants will be monitored every 3 months unless they start a new anti-cancer treatment or leave the study.\n\nDuring the study, participants will undergo various health measurements and observations, including blood sampling and urine collections. Each participant will be in this study for up to approximately 4 years. Tovorafenib will be provided to participants who tolerate it for as long as their disease does not progress.\n\nOnce tovorafenib becomes approved and commercially available in Japan, participants may transition to the commercial drug for continued treatment.\n\nA participant may withdraw consent to participate at any time.",[27],"Low-grade Glioma",[29,30],"BRAF-altered Recurrent Low-grade Glioma","Progressive Low-grade Glioma","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2026-03-03",{"date":39,"type":21},"2030-07-31",{"name":41,"class":42},"Ipsen","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":69,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"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":52,"type":21},124,[24],"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.",[56,57,58,59,60,61,62,63,64,65,66,67,68],"Melanoma","Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[70,71,72,73,74,75,76],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","2026-06-29",{"date":34,"type":35},{"date":80,"type":35},"2022-11-30",{"date":82,"type":21},"2029-06-18",{"name":84,"class":42},"Pfizer",83,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100399771","phase-1-trametinib-and-everolimus-for-treatment-of-pediatric-and-young-adult-patients-with-recurrent-gliomas-pnoc021-100399771","NCT04485559","Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)","PNOC021: A Phase I Trial Evaluating the Combination of Trametinib and Everolimus in Pediatric and Young Adult Patients With Recurrent Low-Grade Gliomas and High Grade Gliomas","Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high grade glioma (HGG) (WHO grade III-VI)\n\n  * Participants with LGG who have had surgery alone are not eligible.\n  * Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected\n  * Participants with spinal cord primaries or disseminated disease are eligible\n* For enrollment, snap frozen tissue (150 mg) or 10 unstained 10 um formalin-fixed, paraffin-embedded (FFPE) slides for comprehensive genomic testing or results of prior testing is required\n\n  * If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs\n* Participants must have evaluable disease\n* Prior therapy: Participants must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, biologics, immunotherapy, or radiotherapy prior to entering this study\n\n  * Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if they had received nitrosourea. Biologic agents: Participant must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent \\>= 7 days prior to study registration. For biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration\n\n    * Participants may have received prior treatment with a mitogen-activated extracellular signal-regulated kinase (MEK) or Mechanistic target of rapamycin (mTOR) inhibitor but must not have developed severe (grade III or IV) clinically significant toxicity. (Participants who developed grade III or IV toxicity which was not presumed by the treating physician to be medically significant should be discussed with the study chair or co-chair)\n  * Monoclonal antibody treatment: Participants must have received their last dose at least four weeks prior to study registration\n  * Radiation: Participants must have: had their last fraction of local irradiation to the primary tumor, craniospinal irradiation (\\> 24 Gy) or total body irradiation \\> 12 weeks prior to registration; investigators are reminded to review potentially eligible cases to confirm disease progression and avoid confusion with pseudo-progression\n  * Bone marrow transplant: Participants must be: \\>= 6 months since allogeneic bone marrow transplant prior to registration; \\>= 3 months since autologous bone marrow\u002Fstem cell prior to registration\n  * Corticosteroids: Participants who are receiving steroids must be on a stable or decreasing dose for at least 1 week prior to registration\n* Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants =\\\u003C 16 years of age. 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* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (unsupported)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Hemoglobin \\>= 8 m\u002FdL (may be supported)\n* International normalized ratio (INR) =\\\u003C 1.5\n* Creatinine clearance or radioisotope growth factor receptor (rGFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine based on age\u002Fgender as follows:\n\n  * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n  * \\>= 16 years: 1.7 (male), 1.4 (female)\n* Bilirubin (sum of conjugated + unconjugated) =\\\u003C 1.5 x upper limit of normal (ULN) for age\n* Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Serum albumin \\>= 2 g\u002FdL\n* Sodium, potassium, calcium and magnesium within 1.5 x institutional lower limit of normal (LLN) or ULN\n* Participants must have cholesterol level \\\u003C 350 mg\u002FdL and triglycerides \\\u003C 400 mg\u002FdL before starting therapy. In case one or both of these are exceeded, the participant can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol \\\u003C 350 mg\u002FdL and triglycerides \\\u003C 400mg\u002Fdl before start of therapy\n* Participants with seizure disorder may be enrolled if well controlled. Participants must be on non-enzyme inducing anticonvulsants which are not excluded on study therapy\n* Participants with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration\n* Corrected QT (QTc) interval =\\\u003C 450 msecs\n* Left ventricular ejection fraction (LVEF) \\>= 50%\n* Pulse oximeter (Ox) \\> 93% on room air\n* Hypertension\n\n  * Participants 3-17 years of age must have a blood pressure that is =\\\u003C 95th percentile for age, height, and gender at the time of registration\n  * Participants who are \\>= 18 years of age must have a blood pressure that is \\\u003C 140\u002F90 mm of Hg at the time of registration\n* Participants must agree to use adequate contraception: The effects of trametinib and everolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and males of child fathering potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of trametinib and everolimus administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* A legal parent\u002Fguardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate per institutional guidelines\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agent for treatment of their tumor\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or trametinib\n* Participants without available tissue from prior surgery. (If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs)\n* Participant is receiving any of the following medications within 7 days prior to enrollment (If participants require (re)initiation of these agents after enrollment and prior to start of therapy they will not be eligible to initiate study therapy):\n\n  * Known strong inducers or inhibitors of CYP3A4\u002F5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos, starfruit, and Seville oranges\n  * Substrates of CYP3A4\u002F5 with a narrow therapeutic index\n  * Herbal preparations\u002Fmedications (except for vitamins) including, but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng. Participants should stop using all herbal medications at least 7 days prior to enrollment\n  * As part of the enrollment\u002Finformed consent procedures, the participant and\u002For legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product\n* Women of childbearing potential who are pregnant or breast-feeding\n\n  * Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of enrollment AND 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* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised\n* Participants with known hepatitis B or C are not eligible\n* Participants with any clinically significant unrelated systemic illness (serious infectious or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the opinion of the investigator would interfere with the study procedures or results\n* Participants with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above are excluded","1 Year",{"count":95,"type":21},50,[24],"This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.",[99,27,66],"Recurrent World Health Organization (WHO) Grade II Glioma",[101,102,74,103],"Mitogen-activated protein kinase (MAPK)","phosphatidylinositol 3-kinase (PI3K)","PI3K","2026-06-16",{"date":106,"type":35},"2026-06-17",{"date":108,"type":35},"2020-12-09",{"date":110,"type":21},"2027-12-31",{"name":112,"class":113},"University of California, San Francisco","OTHER",17,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100375279","phase-3-a-study-of-the-drugs-selumetinib-vs-carboplatin-and-vincristine-in-patients-with-low-grade-glioma-100375279","NCT04166409","A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma","A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)","Inclusion Criteria:\n\n* Patients must be \\>= 2 years and =\\\u003C 21 years at the time of enrollment\n* Patients must have a body surface area (BSA) of \\>= 0.5 m\\^2 at enrollment\n* Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) Childhood Cancer Data Initiative (CCDI)-MCI, or accepted Clinical Laboratory Improvement Act (CLIA)-certified test and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy\u002Fsurgery and treatment initiation.\n\n  * Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and\u002For radiation) are eligible\n  * Patients must have two-dimensional measurable tumor \\>= 1 cm\\^2 to be eligible\n  * Patients with ependymoma are not eligible\n* Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization \\[WHO\\] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma\n* Patients with metastatic disease or multiple independent primary LGG are eligible\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR a serum creatinine based on age\u002Fsex as follows (performed within 7 days prior to enrollment):\n\n  * Age: Maximum Serum Creatinine (mg\u002FdL)\n  * 2 to \\\u003C 6 years: 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years: 1 mg\u002FdL (male); 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years: 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years: 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n  * \\>= 16 years: 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect \\[unconjugated\\] bilirubin levels as long as their direct \\[conjugated\\] bilirubin is \\\u003C 3.1 mg\u002FdL)\n* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL (performed within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U\u002FL\n* Albumin \\>= 2 g\u002FdL (performed within 7 days prior to enrollment)\n* Left ventricular ejection fraction (LVEF) \\>= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment)\n* Corrected QT (QTc) interval =\\\u003C 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment)\n* Absolute neutrophil count \\>= 1,000\u002FuL (unsupported) (performed within 7 days prior to enrollment)\n* Platelets \\>= 100,000\u002FuL (unsupported) (performed within 7 days prior to enrollment)\n* Hemoglobin \\>= 8 g\u002FdL (may be supported) (performed within 7 days prior to enrollment)\n* Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment\n* Patients 2-17 years of age must have a blood pressure that is =\\\u003C 95th percentile for age, height, and sex at the time of enrollment (with or without the use of anti-hypertensive medications)\n* Patients \\>= 18 years of age must have a blood pressure =\\\u003C 130\u002F80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)\n* Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension\n* All patients must have ophthalmology toxicity assessments performed within 8 weeks prior to enrollment\n* For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and\u002For spine (depending on the site(s) of primary disease) with and without contrast must be performed within 8 weeks prior to enrollment\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have the ability to swallow whole capsules\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n* All patients have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)\n* All patients have been consented and enrolled on APEC14B1 (NCT02402244) Part A for Pre-Enrollment Eligibility Screening for ACNS1833\n\nExclusion Criteria:\n\n* Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention (with the exclusion of laser interstitial thermal therapy \\[LITT\\]) is permitted\n* Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible\n* Patients with diffuse intrinsic pontine tumors as seen on MRI (\\> 2\u002F3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I\u002FII histology\n* Patients may not be receiving any other investigational agents\n* Patients with any serious medical or psychiatric illness\u002Fcondition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements\u002Ftreatment\n* Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible\n* Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants are not eligible\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 1 week after stopping study therapy are not eligible.\n\n  * Note: Women study participants of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of selumetinib. Men study participants with sexual partners who are pregnant or who are of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of study agent. Acceptable contraception includes implants, injectables, or oral contraceptives (all combined with barrier methods), some intrauterine devices (IUDs), vasectomy or abstinence\n* Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented\n* Symptomatic heart failure\n* New York Health Association (NYHA) class II-IV prior or current cardiomyopathy\n* Severe valvular heart disease\n* History of atrial fibrillation\n* Current or past history of central serous retinopathy\n* Current or past history of retinal vein occlusion or retinal detachment\n* Patients with uncontrolled glaucoma\n\n  * If checking pressure is clinically indicated, patients with intraocular pressure (IOP) \\> 22 mmHg or ULN adjusted by age are not eligible\n* Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E\n* Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.\n\n  * Note: Patients must have healed from any prior surgery\n* Patients who have an uncontrolled infection are not eligible","2 Years","21 Years",{"count":125,"type":21},170,[127],"PHASE3","This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.",[130,65,131,132,133,134],"Low Grade Astrocytoma","Metastatic Low Grade Astrocytoma","Metastatic Low Grade Glioma","WHO Grade 1 Glioma","WHO Grade 2 Glioma",{"date":106,"type":35},{"date":137,"type":35},"2020-01-31",{"date":139,"type":21},"2030-12-31",{"name":141,"class":142},"National Cancer Institute (NCI)","NIH",132,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},"100601419","phase-2-dabrafenib-and-trametinib-for-braf-v600-mutant-low-grade-gliomas-100601419","NCT07110246","Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas","A Phase 2 De-escalation Study of Dabrafenib and Trametinib for Patients With BRAF V600 Mutant Low-Grade Gliomas","PNOC037","Inclusion Criteria:\n\n* Participants must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by immunohistochemistry or sequencing\n* Participants must have measurable tumor.\n\n  \\* For participants with measurable disease, this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) with a minimum size of no less than double the slice thickness. Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy. Participants without measurable disease may be considered for enrollment and followed for survival and progression purposes but will not be included as part of a measurable disease cohort.\n* Cohort 1:\n\n  * Participants must have no prior therapy, except for surgical intervention (i.e. biopsy or resection)\n  * Participants may currently be taking dabrafenib and trametinib as frontline therapy, with a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this protocol. For participants entering the trial currently taking dabrafenib and trametinib, they must be taking a dose that is within 20% of the standard dosing for both drugs based on age and weight. Participants who are already on dabrafenib and trametinib when enrolling on trial and whose dosing deviates more than 20% from the protocol nomogram need to be discussed with the study chairs. Eligibility for these participants will be based on ability to wean within the parameters of the protocol\n* Cohort 2:\n\n  \\* Participants must have a history of recurrent or progressive disease following prior therapy (e.g., carboplatin and vincristine, vinblastine, bevacizumab, mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor, radiation therapy etc). Participants who previously completed a course of therapy with dabrafenib and trametinib, who did not progress on this therapy, and who are beyond 6 months from completion of therapy are eligible for retreatment.\n\n  \\*\\* Participants may currently be taking dabrafenib and trametinib as therapy for disease recurrence, for a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this protocol. For participants entering the trial currently taking dabrafenib and trametinib, they must be taking dose that is within 20% of the standard dosing for both drugs based on age and weight. Participants who are already on dabrafenib and trametinib when enrolling on trial and whose dosing deviates more than 20% from the protocol nomogram need to be discussed with the study chairs. Eligibility for these participants will be based on ability to wean within the parameters of the protocol\n* Participants must have received their last dose of chemotherapy 3 weeks prior to enrollment (6 weeks for nitrosoureas) and recovered from acute adverse events due to agents administered\n* Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent except dabrafenib and trametinib. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants must be discussed with study chairs\n* Radiation:\n\n  * No prior radiation is allowed for participants in Cohort 1\n  * Participants in Cohort 2 must have:\n\n    * Had their last fraction of local irradiation to primary tumor ≥ 12 weeks prior to registration\n    * Had their last fraction of craniospinal irradiation ≥ 12 weeks prior to registration\n    * At least 14 days after local palliative radiation (small-port)\n* Age: ≥ 12 months and \\\u003C 25 years old\n* Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. 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* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3\n* Platelet count ≥ 100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* A serum creatinine ≤ 1.5 upper limit of normal (ULN) based on age and gender\n* Total bilirubin ≤ 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 3 x ULN\n* Aspartate aminotransferase (AST) ≤ 3 x ULN\n* Participants with seizure disorder may be enrolled if well controlled\n* Left ventricular ejection fraction (LVEF) greater than or equal to institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function)\n* Correct QT (QTc) interval \\\u003C 480 msecs\n* Patient must agree to adequate contraception. (The effects of dabrafenib and trametinib on the developing human fetus are unknown. For this reason and because agents as well as other therapeutic agents used on this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method birth control, or abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of the study medication administration. Should a women become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately)\n* A legal parent\u002Fguardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate\n* Participants must enroll on Pediatric Neuro-Oncology Consortium (PNOC) comprehensive follow up protocol (PNOC COMP) if PNOC COMP is open to accrual at the enrolling institution\n* Pathology reports, next generation sequencing reports, or both, confirming BRAF V600E mutation status must be submitted at the time of enrollment\n\nExclusion Criteria:\n\n* Participant's tumor has any of the following additional previously known or expected activating molecular alterations:\n\n  * Isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutation\n  * Histone H3 mutation (p.K28M, p.G35R, p.G35V)\n  * Neurofibromatosis Type 1 (NF-1) loss of function alteration\n* Participants who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and trametinib\n* Medications that are affected by the induction of CYP3A4 and CYP2C9 should be avoided or used cautiously. Dabrafenib has been shown to induce CYP3A4 and CYP2C9. In addition, dabrafenib is an in vitro inducer of CYP2B6, CYP2C8, CYP2C19, Uridine 5'-diphospho (UDP)-glucuronosyltransferase. Co-administration of dabrafenib and medications which are affected by the induction of these enzymes (including warfarin) and transporters may result in loss of efficacy. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the participant and\u002For legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection\n* Women of childbearing potential must not be pregnant or breast-feeding\n* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised","12 Months",{"count":154,"type":21},96,[156],"PHASE2","This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.",[159,27,160,161],"BRAF V600 Mutation","Low Grade Glioma of Brain","Recurrent Low Grade Glioma","2026-06-12",{"date":104,"type":35},{"date":165,"type":35},"2025-11-07",{"date":167,"type":21},"2032-03-31",{"name":112,"class":113},7,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100358547","rehabilitation-and-longitudinal-follow-up-of-cognition-in-adult-lower-grade-gliomas-100358547","NCT03948490","Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas","Arm 1:\n\nInclusion Criteria:\n\n* Histologically confirmed low grade supratentorial primary brain tumor\n* \\>= 18 years old\n* Life expectancy \\> 12 weeks\n* Karnofsky performance status (KPS) \\>= 70\n* Must speak and be able to read English fluently\n* Must have access to the internet\n* Must have text enabled cellphone\n* Must be receiving MRI scans at University of California, San Francisco (UCSF)\n* Must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 3 months\n* Must be \\>= 6 months from craniotomy\n* Must have subjective complaints of cognitive deficits\n* Must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics\n* Must score \\\u003C= 1 SD below normal on ≥ 2 or more domains of baseline neuropsychological assessments\n\nExclusion Criteria:\n\n* Diagnosis or evidence of any of the following:\n* • Glioblastoma\n* • Extra-axial disease (i.e. meningioma)\n* • Infra-tentorial disease\n* Are not able to comply with study and\u002For follow-up procedures\n* Are unable to complete or score \\>= 3 cognitive tests at baseline, which is indicative that patients would be unable to complete the cognitive rehabilitation interventions\n* Are acutely suicidal, psychotic, and\u002For gravely disabled.\n* Patients who, based on the neuropsychologist's opinion, are unable to participate in cognitive testing and\u002For cognitive rehab secondary to significant neurologic deficit\n\nArm 2:\n\nInclusion Criteria:\n\n* Have a presumed low grade primary brain tumor and either be undergoing definitive surgery or have had surgical resection within the last 4 months.\n* Prior surgery is allowed if they have not received additional tumor directed treatment.\n* \\>= 18 years old\n* Must speak and be able to read English fluently.\n* Plan to continue to care in neuro-oncology at UCSF\n* Must be receiving MRI scans.\n\nExclusion Criteria:\n\n* Diagnosis or evidence of any of the following:\n* • Glioblastoma\n* • Extra-axial disease (i.e. meningioma)\n* Are not able to comply with study and\u002For follow-up procedures\n* Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)","18 Years",{"count":178,"type":21},97,[180],"NA","Patients with glial brain tumors have increasingly improved outcomes, with median survival of 5-15 years. However, the treatments, including surgery, radiation, and chemotherapy, often lead to impaired attention, working memory, and other cognitive functions. These cognitive deficits frequently have significant impact on patient quality of life. Although currently, there is no established standard of care to treat cognitive deficits in brain tumor patients, standard cognitive rehabilitative treatments have been developed for those with traumatic brain injury and stroke. However, the feasibility and efficacy of these cognitive treatments in individuals with brain tumors remains unclear.",[27],[184,185],"cognitive impairment","quality of life","2026-06-02",{"date":188,"type":35},"2026-06-04",{"date":190,"type":35},"2019-06-07",{"date":192,"type":21},"2027-03-31",{"name":112,"class":113},1,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":20},"100643747","low-grade-gliomas-in-argentina-incidence-survival-and-therapeutic-strategies-100643747","NCT07631338","Low-grade Gliomas in Argentina: Incidence, Survival, and Therapeutic Strategies","Study population cohort 1\n\n* Inclusion Criteria\n\n  * Adult patients (≥18 years old) affiliated to the health plan of Hospital Italiano de Buenos Aires.\n  * Documented clinical follow-up of at least 1 year during the study period.\n* Exclusion Criteria\n\n  * Patients not affiliated to the health plan of the Hospital Italiano de Buenos Aires.\n\nStudy population cohort 2\n\n* Inclusion Criteria\n\n  * Adult patients (≥18 years) with histopathologically confirmed diagnosis of low-grade glioma (WHO grades I and II).\n* Exclusion Criteria\n\n  * Incomplete or doubtful diagnosis based on histopathologic and molecular criteria.",{"count":202,"type":21},40,"OBSERVATIONAL","Low-grade gliomas (LGG) are slow-growing primary brain tumors (WHO grades I-II), and their incidence, survival, and treatment patterns in middle-income settings such as Argentina remain poorly characterized. This retrospective, multicenter study comprises two complementary cohorts:\n\n1. Cohort 1: The \"captive\" population covered under the Hospital Italiano de Buenos Aires Health Plan (January 2011-December 2023) to estimate LGG incidence density.\n2. Cohort 2: Histologically confirmed LGG patients treated at the major referral centers to describe overall survival (OS) and disease-free survival (DFS) at 1 and 5 years.\n\nDemographic, clinical, pathological, and treatment data will be collected in a centralized REDCap database.\n\nThe primary objective is to describe LGG incidence in Argentina and estimate survival using Kaplan-Meier curves. The secondary objectives include characterizing therapeutic strategies, molecular mutations, and prognostic factors through Cox regression analysis. This registry will fill a critical gap in LGG epidemiology in middle-income countries and generate hypotheses for future research.",[27],[207,57,208,209,210,211],"Low-grade glioma","Brain tumor","Neuro-oncology","Incidence","Survival","2026-06-01",{"date":214,"type":35},"2026-06-08",{"date":216,"type":35},"2026-04-01",{"date":218,"type":21},"2027-05-31",{"name":220,"class":113},"Hospital Italiano de Buenos Aires",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":123,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":194},"100481940","early-phase-1-evaluation-of-18f-fluciclovine-positron-emission-tomography---magnetic-resonance-imaging-pet-mri-in-lgg-100481940","NCT05555550","Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG","Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)","Inclusion Criteria\n\n1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.\n2. Participants must have evaluable disease (1x1 cm tumor on MRI)\n3. Scheduled to receive systemic therapy for LGG\n4. Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. 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.\n5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration\n6. Being on a treatment regimen does not exclude a subject from enrollment.\n\nExclusion Criteria\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Pregnant participants\n3. Participants who weigh less than 8 kg.\n4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.\n5. Participants with a history of abnormal kidney function or creatinine \\>= CTCAE v5.0 grade 2 at time of study registration.\n6. Participants with primary tumors of the spinal cord.",{"count":229,"type":21},30,[231],"EARLY_PHASE1","The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.",[57,27,160,234,235],"Glioma, Malignant","Glioma Intracranial",[57,27,160,234,235,237],"18F-Fluciclovine","2026-04-24",{"date":240,"type":35},"2026-04-29",{"date":242,"type":21},"2026-07-29",{"date":244,"type":21},"2027-09",{"name":246,"class":113},"Children's Hospital of Philadelphia",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":18,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":194},"100631865","efficacy-of-laser-interstitial-thermal-therapy-in-young-persons-with-low-grade-glioma-100631865","NCT07506239","Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma","PNOC042: A Phase 2, Multi-institutional Trial, Evaluating the Efficacy of Laser Interstitial Thermal Therapy (LITT) in Children, Adolescents and Young Adults With Recurrent or Progressive Low-grade Gliomas (LGG)","Inclusion Criteria:\n\n* Participants must have recurrent or progressive pediatric LGG who have received at least one prior treatment. Prior treatment may include surgery alone and\u002For systemic therapy.\n* Participants must have histologically confirmed LGG that is recurrent or progressive after prior treatment and determined to be a candidate for LITT by central review. All patients will undergo central review prior to LITT. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria.\n* Tumor size: up to 5 cm in largest dimension not including any cystic component. Larger tumors will need to be discussed with the study team. Additional adjunctive interventions such as cyst aspiration prior to or concurrent with a LITT procedure is allowed at the treating surgeon's discretion.\n\nTumor location: Tumors must be located in areas of the brain or central nervous system that are accessible and considered safe for LITT, as determined by central review.\n\n* Suprasellar gliomas not arising from the optic pathway are eligible.\n* Multifocal or metastatic LGGs are eligible, provided that the growing lesions are suitable for LITT.\n* Exophytic brainstem lesions, which are more accessible and present a lower risk, may be eligible for LITT.\n* A patient with stable leptomeningeal disease and a separate growing lesion suitable for LITT is eligible for the study.\n\n  * Prior Therapy: Participants may have had LITT for other medical indications, provided that the lesion being considered for this study has not previously undergone LITT, except for patients who have received LITT for an intracranial lesion that has shown progression post-LITT beyond 15 months would be eligible.\n  * Participants must have fully recovered from the acute toxic effects of all prior chemotherapy or targeted therapy prior to entering this study and would be eligible for surgical intervention per institutional guidelines.\n* Bevacizumab: participants must have received last dose \\> 21 days prior to study registration.\n* Participants must have had chemotherapy \\> 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.\n* Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such patients should also be discussed with study chairs.\n\n  * Radiation:\n\nParticipants must have:\n\n* Had their last fraction of local irradiation or focal radiosurgery to primary tumor ≥12 weeks prior to registration.\n* Had their last fraction of craniospinal irradiation or total body irradiation ≥ 12 weeks prior to registration\n\n  * Age \\>= 2 years to \\\u003C= 25 years of age\n  * Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. 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  * Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.\n  * Patients must be surgically eligible per institutional standards.\n  * Patients must co-enroll to Pediatric Neuro-oncology Consortium (PNOC) COMP if PNOC COMP is open to accrual at the enrolling institution.\n  * A legal parent\u002Fguardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.\n\nExclusion Criteria:\n\n* Any contraindication to the use of LITT, such as but not limited to:\n\n  * Optic pathway gliomas\n  * Spinal tumors\n  * Brainstem Lesions: Infiltrative brainstem lesions are excluded. However, exophytic brainstem lesions, which are more accessible and present a lower risk, may be eligible for LITT.\n  * Any lesion\u002Flocation determined by central review to be contraindicated for LITT.\n* The presence of uncontrolled leptomeningeal disease or extracranial disease including:\n\n  * Evidence of untreated obstructive hydrocephalus or mass effect causing \\>10 millimeter (mm) midline shift\n  * Presence of symptomatic intratumoral hemorrhage (Grade 3 \\& 4). Intratumoral hemorrhage grade 2 needs to be discussed with study team.\n* Participants who are receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.\n\nImportant note: The eligibility criteria listed above are interpreted literally and cannot be waived.",{"count":202,"type":21},[180],"This study aims to evaluate the efficacy of Laser Interstitial Thermal Therapy (LITT) in treating recurrent or progressive, low-grade gliomas (LGG) in pediatric, adolescent and young adult patients.",[27,161,160,258],"Pediatric Cancer",[260],"Interstitial Laser Therapy","2026-03-26",{"date":216,"type":35},{"date":264,"type":35},"2026-03-25",{"date":266,"type":21},"2031-01-01",{"name":112,"class":113},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":194},"100526280","phase-2-post-operative-dosing-of-dexamethasone-in-patients-with-brain-tumors-after-a-craniotomy-pods-trial-100526280","NCT06132685","Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial","Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)","Inclusion Criteria:\n\n* Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis\n* Age equal to or above 18\n\nExclusion Criteria:\n\n* Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction\n* Tumor causing compression of the sella or pituitary dysfunction\n* Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia\n* Taking immunosuppressive drugs - including but not limited to methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeks of recent daily corticosteroid use or the use of corticosteroids equivalent to \\> 85 mg of dexamethasone in the last month\n* Current lymphoma or leukemia\n* History of solid organ transplant\n* Minors \\\u003C 18\n* Pregnant women\n* History of cerebrovascular accident leading to neurologic deficit",{"count":276,"type":21},200,[156],"This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.",[65,280,281,282],"Malignant Brain Glioma","Malignant Brain Neoplasm","Meningioma","2026-02-06",{"date":285,"type":35},"2026-02-10",{"date":287,"type":35},"2025-01-09",{"date":289,"type":21},"2028-07-30",{"name":291,"class":113},"Emory University",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":194},"100433361","phase-1-sj901-evaluation-of-mirdametinib-in-children-adolescents-and-young-adults-with-low-grade-glioma-100433361","NCT04923126","SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma","SJ901: Phase 1\u002F2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1\u002F2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma","Inclusion Criteria: Screening Phase\n\n* Participants with histologically confirmed or suspected low-grade glioma, including neuronal and mixed neuronal-glial tumors\n* Participant must have adequate tumor tissue from primary and\u002For relapsed tumor for central pathology review\n* For Phase 1: Projected to be ≥ 2 years and \\\u003C 25 years at the time of study enrollment\n* Participant's body surface area (BSA) at time of study enrollment must fall within the range outlined in the protocol for the specific dose level under evaluation:\n\n  * Phase 1: Dose Finding\u002FDose-escalation\n\n    * For Phase 1 participant's BSA must fall within the range specified in the protocol for the specific dose level under evaluation.\n  * Phase 2: All Cohorts:\n\n    * For Phase 2 of the study the upper BSA restrictions will be removed.\n* Participant and\u002For guardian can understand and is willing to sign a written informed consent document according to institutional guidelines\n\nExclusion Criteria: Screening Phase\n\n* Participants with known current retinal pathology that is consistent with or a precursor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration\n* Participants with a known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of mirdametinib (e.g., gastric bypass, lap band, or other gastric procedures)\n* Participant with a known history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)\n* Participants with a clinically significant history of chronic interstitial lung disease (such as bronchopulmonary dysplasia, chronic bronchiolitis, obliterative bronchiolitis, chronic aspiration pneumonia, surfactant protein disorder, or other serious chronic pulmonary condition). Participants with a history of asthma, reactive airways disease, or viral pneumonitis are not to be excluded if disease has resolved or is well-controlled.\n\nInclusion Criteria: Phase 1 and Phase 2, All Cohorts\n\n* Participant must be ≥ 2 years and \\\u003C 25 years of age at the time of enrollment\n* Participant's BSA at time of study enrollment must fall within the range outlined below for the specific dose level under evaluation:\n\n  * Phase 1: Dose-finding\u002FDose-escalation\n\n    * For Phase 1 participant's BSA must fall within the range specified in the protocol for the specific dose level under evaluation.\n  * Phase 2: All Cohorts\n\n    * For Phase 2 of the study the upper BSA restrictions will be removed.\n* Participant must have confirmation of one of the following diagnosis per St. Jude Children's Research Hospital central pathology review of primary and\u002For relapsed tumor:\n\n  * Eligible tumors include:\n\n    * Low-grade glioma\u002Fastrocytic tumor\u002Fglioneuronal tumor\u002Fneuroepithelial tumor, not otherwise specified (NOS) or not elsewhere classified (NEC)\n    * Pilocytic astrocytoma\n    * Pilomyxoid astrocytoma\n    * Pleomorphic xanthroastrocytoma\n    * Ganglioglioma\n    * Gangliocytoma\n    * Diffuse glioma, diffuse astrocytoma, oligodendroglioma, or oligoastrocytoma\n    * Papillary glioneuronal tumor\n    * Rosette-forming glioneuronal tumor\n    * Diffuse leptomeningeal glioneuronal tumor\n    * Central neurocytoma, extraventricular neurocytoma\n    * Angiocentric glioma\n    * Dysembryoplastic neuroepithelial tumor (DNET), septal DNET, myxoid glioneuronal tumor\n    * Tectal glioma\n    * Desmoplastic infantile astrocytoma \u002F ganglioglioma\n    * Polymorphous low-grade neuroepithelial tumor of the young\n    * Multinodular and vacuolating neuronal tumor\n* In addition, tumor on central review must show evidence supporting MAPK pathway activation as defined by IHC, FISH and\u002For DNA\u002FRNA sequencing (i.e. BRAF fused or rearranged, FGFR1\u002F2\u002F3 aberration, NF1, NF2, PTPN11, SOS1, RAF1 mutations, MYB or MYBL1 fused or rearranged, etc.) or occur in a participant with known NF1, NF2, SOS1, RAF1, or PTPN11 germline mutation. (Note: tests that show evidence supporting MAPK pathway activation that have been already performed do not need to be repeated as long as deemed acceptable by central review).\n* Participant must have measurable or evaluable disease (as defined in the protocol)\n\n  * Note: Participants with metastatic disease or multiple independent primary LGGs are allowed on study.\n* Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to enrollment with no plans for escalation.\n* Participant must have a Lansky (\\\u003C16 years) or Karnofsky (≥16 years) performance score of ≥ 50 and, in the opinion of the investigator, a minimum life expectancy of at least 6 weeks.\n\n  * Note: 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* Participant must have adequate bone marrow and organ function as defined as:\n\n  * ANC ≥ 1.0 x 10\\^9\u002FL without growth factor support within 7 days\n  * Platelet count ≥ 75x 10\\^9\u002FL without support of a platelet transfusion within 7 days\n  * Hemoglobin ≥8.0 g\u002FdL without support of a blood transfusion within 7 days\n  * Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus must be ≤ grade 1 or corrected to ≤ grade 1 with supplements before first dose of study medication\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN. For the purposes of this study the ULN of ALT and AST is 45 U\u002FL.\n  * Total bilirubin ≤ ULN; or if \\> ULN then direct bilirubin ≤ 1.5 x ULN\n* Adequate renal function defined as:\n\n  * Serum creatinine ≤ the maximum serum creatinine based on age\u002Fgender: Age: 2 to \\\u003C 6 years: maximum serum creatinine (mg\u002FdL) 0.8 (male, female), Age: 6 to \\\u003C10 years: maximum serum creatinine (mg\u002FdL) 1 (male, female), Age: 10 to \\\u003C13 years: maximum serum creatinine (mg\u002FdL) 1.2 (male, female), Age: 13 to \\\u003C16 years: maximum serum creatinine (mg\u002FdL) 1.5 (male); 1.4 (female), Age: ≥ 16 years: maximum serum creatinine (mg\u002FdL) 1.7 (male); 1.4 (female)\n* Adequate cardiac function defined as:\n\n  * LVEF \\> 50% by ECHO\n  * QTc interval ≤ 450 msec for male participants, ≤ 470 msec for female participants after electrolytes have been corrected.\n* Hypertension:\n\n  * Patients 2-12.99 years of age must have a blood pressure that is ≤ 95th percentile +10 mmHg for age, height, and gender at the time of enrollment (with or without the use of anti-hypertensive medications).\n  * Patients ≥ 13 years of age must have a blood pressure ≤ 140\u002F90 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications).\n\n    * Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension.\n* Participants of childbearing\u002Fchild-fathering potential must agree to use contraception.\n* Participants and\u002For guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.\n* Participants who are receiving P-gp and BCRP inhibitors must have received their last dose a week or 5 half-lives (whichever is greater) prior to the first mirdametinib dose.\n\nInclusion Criteria: Phase 1: Progressive or Recurrent Low-Grade Glioma without Previous MEKi exposure\n\n* Participant's tumor must have unambiguously progressed, relapsed, or recurred during or after the most recent prior therapy (chemotherapy or radiotherapy) and pseudoprogression or treatment-related tumor changes have, in the opinion of the investigator, been thoroughly vetted.\n\n  * Progression may be radiographic or clinical (i.e. vision deterioration thought to be related to tumor in patients with optic pathway tumors, or neurologic deterioration thought to be related to tumor) but it must be unequivocal and sufficient to warrant treatment in the opinion of the investigator.\n* Prior therapy:\n\n  * Patients who have received the following:\n\n    * ≤ 3 prior treatment regimens with either myelosuppressive chemotherapy or biologic agents and\u002For\n    * focal radiotherapy\n* Note that a treatment regimen is defined as a single agent (chemotherapeutic or biologic), or a sequential combination of therapies that can include radiotherapy (with or without concurrent radiosensitizer, chemotherapy, or biologic therapy) followed by maintenance therapy (either single or combination) given over a period of time at either diagnosis or relapse.\n* Chemotherapy:\n\n  * Participant must have received their last dose of myelosuppressive anticancer chemotherapy at least 21 days prior to study enrollment or at least 42 days if nitrosourea.\n* Monoclonal antibody treatment and agents with known prolonged half-lives:\n\n  * 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* MEK inhibitors:\n\n  * Patients must not have received prior exposure to any MEK inhibitors\n* XRT\u002FExternal Beam Irradiation including Protons:\n\n  * Participant must have had their last fraction of radiation ≥ 3 months prior to study enrollment\n\nInclusion Criteria: Phase 2, Cohort 1: Newly Diagnosed and\u002For previously untreated (except surgery) Low-Grade Glioma\n\n* No prior anti-cancer treatment except surgery.\n* In the opinion of the investigator tumor must warrant treatment defined as any of the following: unsafe to observe, unequivocally progressing on serial imaging, tumor is causing or at high risk of causing neurologic or vision-related deficits.\n\nInclusion Criteria: Phase 2, Cohort 2: Progressive or Recurrent Low-Grade Glioma without Previous MEK Inhibitor Exposure\n\n* Participant's tumor must have unambiguously progressed, relapsed, or recurred during or after the most recent prior therapy (chemotherapy or radiotherapy) and pseudoprogression or treatment-related tumor changes have, in the opinion of the investigator, been thoroughly vetted.\n\n  * Progression may be radiographic or clinical (i.e. vision deterioration thought to be related to tumor in patients with optic pathway tumors, or neurologic deterioration thought to be related to tumor) but it must be unequivocal and sufficient to warrant treatment in the opinion of the investigator.\n* Prior therapy:\n\n  * Chemotherapy:\n\n    * Participant must have received their last dose of myelosuppressive anticancer chemotherapy at least 21 days prior to study enrollment or at least 42 days if nitrosourea.\n  * Monoclonal antibody treatment and agents with known prolonged half-lives:\n\n    * 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  * MEK inhibitors:\n\n    * Patients must not have received prior exposure to any MEK inhibitors\n  * XRT\u002FExternal Beam Irradiation including Protons:\n\n    * Participant must have had their last fraction of radiation ≥ 3 months prior to study enrollment.\n* Note that for this cohort, there are no limitations on number of prior treatment regimens and participants who have received craniospinal radiation are eligible\n\nInclusion Criteria: Phase 2, Cohort 3: Progressive or Recurrent Low-Grade Glioma with Previous MEK inhibitor Exposure\n\n* Cohort 3A (MEKi responders): Patients who previously received 6 or more cycles of any MEK inhibitor (including mirdametinib) and did NOT progress while on active MEK inhibitor therapy.\n\n  * The progression must have occurred off MEK inhibitor therapy\n  * Participant's tumor must have unambiguously relapsed or clinically progressed. Progression may be radiographic or clinical (i.e. vision deterioration thought to be related to tumor in patients with optic pathway tumors, or neurologic deterioration thought to be related to tumor) but it must be unequivocal and sufficient to warrant treatment in the opinion of the investigator.\n  * Patient must not have discontinued MEKi (specifically mirdametinib) for unacceptable toxicity, and in the opinion of the PI be able to tolerate subsequent courses of MEKi therapy.\n  * Patients must have received treatment with a MEK inhibitor for ≥6 cycles and showed no signs of progression while on active MEK inhibitor therapy.\n  * Patients who received additional anti-tumor therapy following discontinuation of MEK inhibitor can be enrolled in this cohort.\n* Prior Therapy:\n\n  * Chemotherapy:\n\n    * Participant must have received their last dose of myelosuppressive anticancer chemotherapy at least 21 days prior to study enrollment or at least 42 days if nitrosourea.\n  * Monoclonal antibody treatment and agents with known prolonged half-lives:\n\n    * 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  * MEK inhibitors:\n\n    * Participant must have received their last dose of MEKi at least 3 weeks prior to study enrollment.\n  * XRT\u002FExternal Beam Irradiation including Protons:\n\n    * Participant must have had their last fraction of radiation ≥ 3 months prior to study enrollment.\n* Note that for this cohort, there are no limitations on number of prior treatment regimens and participants who have received craniospinal radiation are eligible\n* Cohort 3B (MEKi non-responders): Patients with previous exposure to alternative MEK inhibitors (excluding mirdametinib) who progressed while on active MEK inhibitor therapy\n\n  * Participant's tumor must have unambiguously relapsed or clinically progressed.\n  * Progression may be radiographic or clinical (i.e. vision deterioration thought to be related to tumor in patients with optic pathway tumors, or neurologic deterioration thought to be related to tumor) but it must be unequivocal and sufficient to warrant treatment in the opinion of the investigator. Progression or recurrence must have occurred while on active MEK inhibitor therapy (excluding mirdametinib)\n  * Participants are eligible regardless of how many prior cycles were received or prior history of response (i.e. PR, Major Response, or CR)\n* Patients who received additional anti-tumor therapy following discontinuation of MEK inhibitor can be enrolled in this cohort as long as they meet the above criteria.\n* Prior Therapy:\n\n  * Chemotherapy:\n\n    * Participant must have received their last dose of myelosuppressive anticancer chemotherapy at least 21 days prior to study enrollment or at least 42 days if nitrosourea.\n  * Monoclonal antibody treatment and agents with known prolonged half-lives:\n\n    * 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  * Alternative MEK inhibitor:\n\n    * Participant must have received their last dose of MEKi (excluding mirdametinib) at least 3 weeks prior to study enrollment.\n  * XRT\u002FExternal Beam Irradiation including Protons:\n\n    * Participant must have had their last fraction of radiation ≥ 3 months prior to study enrollment.\n* Note that for this cohort, there are no limitations on number of prior treatment regimens and participants who have received craniospinal radiation are eligible.\n\nExclusion Criteria: Phase 1 and Phase 2, All Cohorts\n\n* Participants whose tumor on central review is any of the following:\n\n  * High-grade (WHO III or IV)\n  * Subependymal giant cell astrocytoma\n  * Ependymoma\n  * Histone H3 K27M\u002FK28M or G34\u002FG35-mutant\n  * BRAF V600 mutant\n  * NTRK1\u002F2\u002F3, ALK, or ROS1 fusion-positive\n  * IDH 1\u002F2 mutant\n* Participant who is currently receiving any other anticancer or investigational agents (\\^11C-methionine allowed) or still recovering from acute toxicity potentially related to the agent.\n* Ophthalmologic Conditions\n\n  * Patients with central serous retinopathy\n  * Patients with retinal vein occlusion or retinal detachment\n  * Patients with uncontrolled glaucoma\n\n    * If checking pressure is clinically indicated and feasible per patient's age and ability to complete exam, patients with IOP \\> 22 mmHg or ULN adjusted by age are not eligible\n* Participants with other clinically significant medical disorders (i.e. serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction) that in the investigator's judgement could compromise their ability to tolerate or absorb protocol therapy or would interfere with the study procedures or results.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 16 weeks after stopping study therapy are not eligible.\n* Participants are excluded if unable to comply with protocol guidelines.","24 Years",{"count":143,"type":21},[24,156],"This is an open-label, multi-center, Phase 1\u002F2 study of the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).",[304,305,306],"Low-Grade Glioma","Recurrent Low-Grade Glioma","Progressive Low-Grade Glioma",[308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337],"Brain tumors in Adolescent","Brain tumors in Children","Brain tumors in Young Adults","Astrocytic tumor","Glioneuronal tumor","Neuroepithelial tumor, not otherwise specified (NOS)","Neuroepithelial tumor, not elsewhere classified (NEC)","Pilocytic astrocytoma","Pilomyxoid astrocytoma","Pleomorphic xanthroastrocytoma","Ganglioglioma","Gangliocytoma","Diffuse glioma","Diffuse astrocytoma","Oligodendroglioma","Oligoastrocytoma","Papillary glioneuronal tumor","Rosette-forming glioneuronal tumor","Diffuse leptomeningeal glioneuronal tumor","Central neurocytoma","Extraventricular neurocytoma","Angiocentric glioma","Dysembryoplastic neuroepithelial tumor (DNET)","Septal Dysembryoplastic neuroepithelial tumor (DNET)","Myxoid glioneuronal tumor","Tectal glioma","Desmoplastic infantile astrocytoma","Desmoplastic infantile ganglioglioma","Polymorphous low-grade neuroepithelial tumor of the young","Multinodular and vacuolating neuronal tumor","2026-02-02",{"date":340,"type":35},"2026-02-04",{"date":342,"type":35},"2021-06-21",{"date":344,"type":21},"2031-06",{"name":346,"class":113},"St. Jude Children's Research Hospital",{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":194},"100428919","a-living-tissue-bank-of-patient-derived-organoids-from-glioma-tumors-100428919","NCT04865315","A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors","HiLoGlio Organoid Study: 'A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors'","HiLoGlio","Inclusion Criteria:\n\n* MRI diagnosis of low grade glioma (LGG) or high grade glioma (HGG)\n* Age 18 years or older\n* Patient is eligible for a resection of the tumor\n\nExclusion Criteria:\n\n* Contra-inidication for neurosurgical resection of the tumor.\n* Incapacitated patient, unable to give informed consent.",{"count":95,"type":21},"There is a high medical need to improve treatment outcome for high-grade and low-grade glioma since no curative treatment is available. To achieve this goal, a broader understanding is needed of the causes of inter-and intratumoral heterogeneity; glioma dedifferentiation and invasion; the major determinants of malignancy and treatment failure in glioma patients. Patient-derived organoid (PDOs) of high-grade gliomas and low-grade gliomas will be used to identify the mechanisms that underlie this malignant behaviour and treatment resistance. This insight may be used to develop patient avatars to simultaneously test multiple new treatment modalities that are predictive for survival and quality of life of glioma patients.",[27,66],[359,360],"Prospective study","Patient-derived organoids","2026-01-26",{"date":363,"type":35},"2026-01-27",{"date":365,"type":35},"2022-05-01",{"date":367,"type":21},"2028-12",{"name":369,"class":113},"Maastricht Radiation Oncology",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":123,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":194},"100236609","phase-2-a-vaccine-trial-for-low-grade-gliomas-100236609","NCT02358187","A Vaccine Trial for Low Grade Gliomas","A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas (LGG)","Inclusion Criteria:\n\nTumor Type\n\n* Unresectable low-grade gliomas that have received at least two chemotherapy\u002Fbiologic regimens. Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may have tumor spread within the central nervous system (CNS).\n* HLA-A2 positive based on flow cytometry.\n* Patients must be clinically stable and off or on low-dose (no more than 0.1 mg\u002Fkg\u002Fday, max 4 mg\u002Fday Dexamethasone) corticosteroid for at least one week prior to study registration.\n* Patients must be ≥ 12 months and \\\u003C 22 years of age at the time of HLA-A2 screening.\n* Patients must have a performance status of ≥ 70; (Karnofsky if \\> 16 years and Lansky if ≤ 16 years of age.\n* Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal. Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not sufficiently been investigated, pregnant females will not be included in the study.\n* Patients must be free of systemic infection requiring IV antibiotics at the time of registration. Patients must be off IV antibiotics for at least 7 days prior to registration.\n* Patients with adequate organ function as measured by: Bone marrow: absolute neutrophil count (ANC) \\> 1,000\u002Fµ; Platelets \\> 100,000\u002Fµ (transfusion independent); absolute lymphocyte count of ≥ 500\u002Fµ; Hemoglobin \\>8 g\u002Fdl (may be transfused). Hepatic: bilirubin \\\u003C 1.5x institutional normal for age; serum glutamate pyruvate transaminase (SGPT) \\\u003C 3x institutional normal.\n* Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml\u002Fmin\u002Fml\u002Fmin\u002F1.73 m²\n* Patients must have recovered from the toxic effects of prior therapy to grade 1 or better. Patients must be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.\n* No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.\n\nExclusion Criteria:\n\n* Patients living outside of North America are not eligible.\n* Patients may not have received radiation to the index lesion within 1 year of enrollment.\n* Concurrent treatment or medications (must be off for at least 1 week) including:\n\n  * Interferon (e.g. Intron-A®)\n  * Allergy desensitization injections\n  * Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)\n  * Interleukins (e.g. Proleukin®)\n  * Any investigational therapeutic medication\n* Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.\n* Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to no more than 0.1 mg\u002Fkg\u002Fday, max 4 mg\u002Fday dexamethasone for at least one week before study registration. Topical corticosteroids are acceptable.\n* Because patients with immune deficiency are not expected to respond to this therapy, HIV-positive patients are excluded from the study.\n* Patients who have received prior immunotherapy.",{"count":378,"type":21},25,[156],"The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)\u002Ftetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy\u002Fbiologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.",[65],"2026-01-05",{"date":384,"type":35},"2026-01-07",{"date":386,"type":4},"2015-01",{"date":388,"type":21},"2028-12-31",{"name":390,"class":113},"James Felker",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":410,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":427,"locationsCount":194},"100587627","hobscotch-ca-home-based-self-management-and-cognitive-training-changes-lives-in-brain-cancer-100587627","NCT06930846","HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)","HOBSCOTCH-CA","CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion\u002Fexclusion criteria. Inclusion Criteria 2. - 5. and Exclusion Criteria 1. - 3. will be confirmed by referring providers. Participants who learn about the study here and elsewhere will be instructed on how to confirm their eligibility with their provider.\n\nInclusion Criteria for CA Participant:\n\n1. 18 + years\n2. Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)\n3. Diagnosis of primary brain tumor with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT or MRI), confirmed by histopathological examination (Note: some patients being treated for meningioma may be treated with radiotherapy without need for initial histopathologic confirmation)\n4. Patients undergoing surgical and\u002For radiation therapy will have completed their treatment at least 3 months prior to being enrolled in trial (Note: patients receiving chemotherapy or other systemic therapy will be included)\n5. Stable on all CNS acting medications for one month prior to enrollment\n6. Subjective cognitive complaints\n7. Literate and proficient in English\n8. Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8\n\nExclusion Criteria for CA Participant:\n\n1. Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n2. Acute psychiatric disorder or substance abuse\n3. Patients with glioblastoma (GBM)\n\nInclusion Criteria for CA Participant Caregiver:\n\n1. Age 18 +\n2. Caregiver to a patient with a confirmed diagnosis of brain cancer\u002Ftumor survivor\n3. CA Subject has given permission for their caregiver to participate\n4. Literate and proficient in English\n5. Internet access (for Pre-HOBSCOTCH and Session 1)\n6. Telephone access (for Session 8)\n\nExclusion Criteria for CA Participant Caregiver:\n\n1. Significant visual impairment precluding reading or writing\n2. No reliable telephone or internet access",{"count":399,"type":21},125,[180],"The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer\u002Ftumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants.\n\nInvestigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.\n\nHOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a \"pre\" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).",[403,404,61,405,27,322,282,130,406,407,408,409],"Brain Cancer","Brain Tumor","Primary Brain Tumor","Cognitive Dysfunction","Memory Impairment","Memory Disorders","Memory Dysfunction",[411,412,413,414,415,416,417,418,419,420],"Brain cancer survivor","Brain tumor survivor","Cognition","Self-management","Cognitive training","Memory disorders","Cognitive remediation","Caregiver","Caregiver burden","Mindfulness","2025-11-18",{"date":423,"type":35},"2025-11-21",{"date":425,"type":35},"2025-11-03",{"date":367,"type":21},{"name":428,"class":113},"Dartmouth-Hitchcock Medical Center",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":176,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":443,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":194},"100593256","phase-3-fcn-159-monotherapy-versus-chemotherapy-by-investigators-choice-in-pediatric-low-grade-glioma-patients-with-braf-alteration-100593256","NCT07004075","FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration","An Open-label, Randomized, Multi-center Phase III Clinical Study: Aim to Evaluate the Efficacy and Safety of FCN-159 Monotherapy Versus the Treatment by Investigator's Choice in Patients With Pediatric Low-grade Glioma Harboring KIAA1549-BRAF Fusion or BRAF V600E Mutation","Inclusion Criteria:\n\n1. Pediatric patients aged between ≥ 2 years and \\\u003C 18 years; regardless of male or female.\n2. Histologically and\u002For cytologically confirmed diagnosis of low-grade glioma (pLGG diagnosis as Grade 1 or 2 according to the 2021 WHO classification of CNS).\n3. KIAA1549-BRAF fusion or BRAF V600E mutation-positive.\n4. Patients requiring systemic therapy as determined by the investigator, including patients having disease recurrence or progression, or residual disease of surgery, or unresectable.\n5. At least one intracranial measurable lesion that can be reproducibly measured in two dimensions on T2-FLAIR, with the minimum size of the bi-perpendicular diameter of ≥ 10 mm, and can be visible on two or more imaging slice.\n\n6\\. Karnofsky performance score or Lansky performance score ≥ 70. 7．Adequate organ function within 14 days before enrollment.\n\nExclusion Criteria:\n\n1. Patients who have previously received any of the following treatments:\n\n   1. Patients who have received chemotherapy drugs or traditional Chinese medicines or herbals with definitive anti-tumor treatment within 4 weeks preceding the first dose of investigational drug;\n   2. Patients who have received growth factors that promote platelet or leukocyte count or function within 14 days preceding the first dose of investigational drug;\n   3. Patients who received radiotherapy, surgery or immunotherapy within 4 weeks preceding the first dose of investigational drug;\n   4. Patients who have participated in other interventional clinical trials within 4 weeks before receiving the first dose of investigational drug;\n   5. Patients who have received live vaccines within 4 weeks preceding the first dose of investigational drug, or patients who have received inactivated vaccines and mRNA vaccines within 14 days preceding the study treatment;\n   6. Patients who have previously received any other MEK 1\u002F2 inhibitors such as Selumetinib or BRAF inhibitors such as Dabrafenib.\n2. Patients with high-grade gliomas, as well as schwannoma, subependymal giant cell astrocytoma (tuberous sclerosis), and diffuse intrinsic pontine gliomas (even if the histological diagnosis is WHO Grade 1 or 2).\n3. Patients who require endotracheal intubation for assisted ventilation or tracheotomy should be excluded.\n4. Patients who have uncontrollable epilepsy as assessed by the investigator.\n5. Patients with dysphagia, active GI diseases, malabsorption syndrome, or other conditions that will interfere with the absorption of the investigational drug.\n6. Patients with clinically significant active bacterial, fungal or viral infections, including hepatitis B virus surface antigen positive and hepatitis B virus DNA exceeding 1000 IU\u002Fml. Hepatitis B carriers are allowed to be enrolled. Patients with positive hepatitis C virus (HCV) antibody test; those who have confirmed human immunodeficiency virus (HIV) infection, and are unwilling to undergo HIV testing.\n7. Patients with history or current evidence of retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), central retinal vein occlusion, glaucoma, and other significant abnormalities in ophthalmological examinations.\n8. Interstitial pneumonia, including clinically significant radiation pneumonitis.\n9. Grade 3 creatine phosphokinase increased (\\>5 × ULN - 10 × ULN).",{"count":437,"type":21},102,[127],"An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation",[27,441,442],"Pediatric Low-grade Gliomas","pLGG With BRAF Alteration","NOT_YET_RECRUITING","2025-06-03",{"date":446,"type":35},"2025-06-04",{"date":448,"type":21},"2025-06-30",{"date":450,"type":21},"2029-04-30",{"name":452,"class":42},"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":466,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"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).","26 Years",{"count":462,"type":21},27,[24,156],"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.",[65,66],[71,467,468,469,470,471,472,473,474],"BRAFV600","KIAA1549 BRAF fusion","nivolumab","dabrafenib","trametinib","MAPK inhibition combined with anti-PD1 immunotherapy","recurrent low grade glioma","high grade glioma","2025-05-23",{"date":477,"type":35},"2025-05-29",{"date":479,"type":35},"2025-04-01",{"date":481,"type":21},"2029-06",{"name":483,"class":113},"Ann & Robert H Lurie Children's Hospital of Chicago",3,{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":493,"maxAge":18,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":194},"100545412","early-phase-1-pilot-study-of-vinblastine-and-tovorafenib-in-pediatric-patients-with-recurrentprogressive-raf-altered-low-grade-gliomas-100545412","NCT06381570","Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent\u002FProgressive RAF Altered Low Grade Gliomas","VICTORY: A Pilot Study to Investigate Safety and Efficacy of Weekly Combination of Intravenous Vinblastine With Oral Type II RAF Inhibitor Tovorafenib in Pediatric Patients With Recurrent\u002FProgressive RAF Altered Low Grade Gliomas","VICTORY","Inclusion Criteria:\n\n1. Age\n\n   a) Patients must be less than or equal to 25 years of age at the time of enrollment.\n2. Study Group\n\n   a) Progressive\u002FRecurrent LGG (non-NF1) with documented BRAF or CRAF alteration as identified through molecular assays as routinely performed at CLIA or other similar certified laboratories.\n3. Diagnosis\n\n   1. All patients must have pathological confirmation of low-grade glioma with BRAF or CRAF alteration.\n   2. Patient must have progressive or recurrent LGG.\n   3. Must have at least 1 measurable lesion, as defined by RANO-LGG criteria.\n   4. Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (WHO grade I and II) by WHO classification of Tumors of the Central Nervous system -5th edition revised with exception of subependymal giant cell astrocytoma.\n4. Prior Therapy\n\n   1. Must have received at least 1 line of systemic therapy prior (at least a vinca alkaloid and\u002For single agent carboplatin and\u002For a MEK or BRAF inhibitor) and have documented evidence of radiographic progression.\n   2. Patients must have fully recovered from the acute toxic effects (≤ Grade I) of all prior anticancer chemotherapy and have undergone the following washout periods, as applicable.\n\n   i. Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) ii. Radiation therapy (XRT): Radiation therapy to the measurable lesion(s) must be completed at least 6 months prior to administration of combination therapy. Patients who have documented radiographic progression less than 6 months from radiotherapy in 1 or more measurable lesions are eligible. At least 2 weeks after the last dose fraction of XRT to the non-target lesion.\n\n   iii. Investigational agent or any other anticancer therapy not defined above: At least four weeks prior to planned start of combination therapy, or five half-lives, whichever is shorter.\n\n   iv. Patients must have recovered from acute effects of any prior surgery. v. Chronic toxicities from prior anticancer therapy must be stable as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤ 2, except ongoing retinopathy which must be ≤ Grade 1.\n5. Performance Level\n\n   a) Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50. Patients who are unable to walk because of paralysis, but who are able to sit in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n6. Tumor Tissue Sample Confirmation that an archival tumor tissue sample is available. If an archival tumor tissue sample is not available, a fresh biopsy should be performed at baseline. Submission of tumor tissue and a blood sample are mandatory and must be submitted within 14 days from enrollment onto the study and prior to initiation of treatment. Biopsy may be either at initial diagnosis or recurrence.\n7. Organ function\n\n   a) Adequate bone marrow function defined as: i. Absolute neutrophil count ≥ 1000\u002Fmm3 ii. Platelet count (unsupported) ≥ 100 x 109\u002FL (transfusions allowed per institutional guidelines; last transfusion \\> 2 weeks prior to enrollment) iii. Hemoglobin (unsupported)≥ 10.0 g\u002FdL (transfusions allowed per institutional guidelines; last transfusion \\> 4 weeks prior to enrollment) iv. Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta®) or 7 days for short-acting growth factor.\n\n   b) Adequate hepatic and renal function defined as: i. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (patients with documented Gilbert's disease may be enrolled with sponsor approval and total bilirubin ≤ 2 x ULN) ii. Serum glutamic-pyruvic transaminase (SGPT)\u002Falanine aminotransferase (ALT) ≤ 2.5 x ULN iii. Serum glutamic-oxaloacetic transaminase (SGOT)\u002Faspartate transaminase (AST) ≤ 2.5 x ULN iv. Serum creatinine within normal limits or estimated glomerular filtration rate\n\n   ≥ 60 ml\u002Fmin\u002F1.73 m2 based on local institutional practice for determination. c) Thyroid functions tests within institutional normal range. Patients on a stable dose of thyroid replacement therapy for a minimum of 3 weeks before starting therapy are eligible.\n\n   d) Adequate cardiac function defined as: i. Left ventricular ejection fraction (LVEF) of ≥ 50% as measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan, or fractional shortening (FS) ≥ 25% (Tissot et al., 2018) as measured by ECHO, within 14 days before enrollment (while not receiving medications for cardiac function). If normal practice at the institution is to provide the LVEF result as a range of values, then the upper value of the range will be used to determine the result.\n\n   ii. QTc (by Fridericia's formula) \\\u003C 470ms as measured by electrocardiogram (ECG) within 14 days before enrollment (while not receiving medications for cardiac function).\n\n   e) Adequate central nervous system (CNS) function defined as: i. Patients with seizures should be stable and not have experienced a significant increase in seizure frequency within 14 days prior to enrollment.\n\n   ii. Patients with neurologic deficits should have deficits that are stable for a minimum of 14 days prior to enrollment.\n\n   iii. Patients receiving steroids for tumor-associated symptoms must be on a stable dose (e.g., no initial\u002Floading dose, no increase or decrease) for 14 days prior to enrollment.\n8. Study specific\n\n   1. Baseline ophthalmology assessment within 28 days of study enrollment.\n   2. MRI assessment within 28 days of study enrollment. MRI done for clinical indication but within the window for study would be permitted as baseline.\n   3. Ability to comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation.\n   4. Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his\u002Fher partner, for the duration of treatment and for 180 days following the last dose of study drug. Effective birth control methods are described in Appendix H.\n   5. Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.\n   6. Patient is able to start treatment within 14 working days of screening.\n   7. Parent\u002Fguardian of child or adolescent patient has the ability to understand, agree to, and sign the study ICF and applicable pediatric assent form before initiation of any protocol related procedures; patient has the ability to give assent, as applicable, at the time of parental\u002Fguardian consent.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria are to be excluded from study participation:\n\n  1. Patient's tumor has additional previously known activating molecular alterations, other than BRAF or CRAF.\n  2. Known or suspected diagnosis of neurofibromatosis Type 1 (NF-1) via genetic testing or current diagnostic clinical criteria.\n  3. History of any major disease, other than the diagnosis of LGG, that might interfere with safe protocol participation.\n  4. Patient with a history or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO), or ophthalmopathy present at baseline who would be considered a risk factor for CSR or RVO. Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) will NOT be considered a significant abnormality for the purposes of this study.\n  5. Major surgery within 14 days (2 weeks) prior to enrollment (does not include central venous access, cyst fenestration or cyst drainage, or ventriculoperitoneal shunt placement or revision).\n  6. Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis\u002Fpulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT interval corrected for heart rate by Fridericia's formula (QTcF) interval \\> 470 ms based on triplicate ECG average.\n  7. Concomitant medications that are strong inhibitors or inducers of CYP2C8 or CYP3A4 within 14 days before initiation of therapy. Concomitant medications that are substrates of BCRP with a narrow therapeutic index within 14 days before initiation of therapy\n  8. Current enrollment in any other investigational treatment study. Participation on a concurrent observational or bio-sampling study is allowed.\n  9. Active systemic bacterial, viral, or fungal infection.\n  10. Nausea and vomiting ≥ National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Grade 2 (for those not controlled by supportive care), malabsorption requiring supplementation, or significant bowel or stomach resection that would preclude adequate absorption of tovorafenib.\n  11. Patient has CTCAE v5.0 Grade 3, creatine phosphokinase (CPK) elevation (\\> 5 × ULN - 10 × ULN).\n  12. Patients who are neurologically unstable despite adequate treatment (e.g., uncontrolled seizures).\n  13. Pregnancy or lactation.\n  14. History of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS). Patients with hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of the investigational medicinal product.\n  15. Other unspecified reasons that, in the opinion of the investigator, make the patient unsuitable for enrollment.","0 Weeks",{"count":495,"type":21},57,[231],"This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories.\n\nThe study will be conducted in two sequential phases:\n\nPhase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)\u002FRecommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD\u002FRP2D would be eligible for intra-patient dose escalation to MTD\u002FRP2D subject to criteria outlined later",[27],[500,501],"RAF altered","non-NF1","2025-05-12",{"date":504,"type":35},"2025-05-15",{"date":506,"type":35},"2024-03-21",{"date":508,"type":21},"2029-03-21",{"name":510,"class":113},"Daniel Morgenstern",{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":536},"100422027","phase-2-a-study-to-evaluate-tovorafenib-in-pediatric-and-young-adult-participants-with-relapsed-or-progressive-low-grade-glioma-and-advance-solid-tumors-100422027","NCT04775485","A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors","FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors","FIREFLY-1","Inclusion Criteria:\n\n* Low Grade Glioma \\& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.\n* Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.\n* Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.\n* Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.\n* Must have at least 1 measurable lesion as defined by RANO (Arms 1 \\& 2) or RECIST v1.1 (Arm 3) criteria\n\nExclusion Criteria:\n\n* Participant's tumor has additional previously-known activating molecular alterations.\n* Participant has symptoms of without radiographically recurrent or radiographically progressive disease.\n* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.\n\nOther inclusion\u002Fexclusion criteria as stipulated by protocol may apply",{"count":520,"type":21},141,[156],"This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.",[27,524],"Advanced Solid Tumor",[27,524,517,526,527],"DAY101","Tovorafenib","2025-03-27",{"date":530,"type":35},"2025-04-10",{"date":532,"type":35},"2021-04-22",{"date":218,"type":21},{"name":535,"class":42},"Day One Biopharmaceuticals, Inc.",35,{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":194},"100568712","phase-2-fg001-in-subjects-with-meningiomas-or-presumed-low-grade-gliomas-scheduled-for-neurosurgery-100568712","NCT06684795","FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery","An Open-label, Non-randomized, Single Dose, Phase II Trial of FG001 (an Optical Imaging Agent) for Localization of Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery","Inclusion Criteria:\n\nSubjects will be entered into this trial only if they meet all the following criteria:\n\n1. Subjects diagnosed with primary brain tumor on MRI suggestive of, meningioma or presumed low-grade glioma (pLGG)\\*\n2. Scheduled for neurosurgery with the objective to remove cancer tissue\n3. Subjects aged 18 years or older\n4. Capable of understanding and giving written informed consent\n5. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone \\[FSH\\] test if there is doubt)\n6. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit.\n7. Subject must not previously have received the trial drug (FG001)\n8. Subjects must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC) \\*Presumed low-grade gliomas in this protocol are defined as diffusely infiltrated non-contrast enhancing tumors on MRI. Patients with known LGG scheduled for re-surgery or primary surgery after a diagnostic biopsy may also be included.\n\nExclusion Criteria:\n\n1. Any known allergy or hypersensitivity to indocyanine green (ICG)\n2. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion (or if breast-feeding willing to pause breast feeding during trial and for 30 days\n3. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator\n4. Pre-existing hepatic and\u002For renal insufficiency\n\n   * INR above 1.7\n   * Estimated GFR (eGFR) below 45 ml\u002Fmin\u002F1.73m2\n5. Unwilling or unable to follow the protocol requirements",{"count":202,"type":21},[156],"In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.",[27,282,57],"2024-11-09",{"date":550,"type":35},"2024-11-12",{"date":552,"type":35},"2024-05-01",{"date":212,"type":21},{"name":555,"class":113},"Rigshospitalet, Denmark",{"id":557,"slug":558,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":565,"conditions":566,"keywords":569,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":194},"100563029","monitoring-of-patients-with-low-grade-gliomas-using-circulating-mirna-100563029","NCT06610851","Monitoring of Patients With Low-grade Gliomas Using Circulating miRNA","GLIBAMIR","Inclusion Criteria:\n\n* Major patient\n* Suffered from a grade 2-3 diffuse glioma\n* Surgery in the neurosurgery department of Caen University Hospital\n* Patient affiliated to a social security scheme\n* Patient followed at Caen University Hospital\n* No opposition from the patient\n\nExclusion Criteria:\n\n* Patients who have undergone biopsy (lack of material for the study, limited value of monitoring for these patients without surgical excision)\n* Patients with grade 1 circumscribed glioma\n* Patients with grade 4 glioma\n* Other non-glial histologies, glioneuronal histology\n* Minor patients\n* Patient not affiliated to a social security scheme\n* Major under guardianship or protected",{"count":564,"type":21},20,"With around 3,400 cases per year in France, diffuse gliomas are the most common primary tumours of the central nervous system. Their grade varies from 2 to 4. Whatever the grade, their prognosis is poor, because tumour recurrence is systematic, because no personalised medicine is available for the treatment of these cancers, and because the tools for monitoring recurrence are imperfect. Treatment of diffuse gliomas is based on removal of as much of the tumour as possible, whatever its grade. Surgery is followed by radiotherapy and chemotherapy depending on the grade and quality of the excision. In the event of recurrence, the patient may be offered second-line chemotherapy or further surgery. During and after treatment, patients are regularly monitored by MRI in order to detect any recurrence as early as possible and propose a new treatment. However, for grade 2 and 3 gliomas, MRI monitoring is imperfect because it cannot detect tumour recurrence at an early stage. Initiation of new treatment at the time of recurrence, which is inevitable, is therefore often delayed, which is harmful for patients.\n\nIt is therefore vital to identify a reliable, easy-to-use and non-invasive biomarker that can be used to monitor patients undergoing surgery for grade 2 and 3 diffuse gliomas, and thus enable earlier diagnosis of recurrence. These biomarkers could be microRNAs.\n\nMicroRNAs are small non-coding RNAs involved in the regulation of genes and, consequently, of the intracellular signalling pathways that govern cell behaviour. They are therefore widely implicated in oncogenesis, and in particular in the mechanisms that promote tumour migration, invasion and proliferation.\n\nSeveral preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumour rates in gliomas. No study has investigated the possibility of using them to detect tumour recurrence earlier in grade 2 and 3 gliomas.\n\nWith this study, the investigators hope to use pro-oncogenic microRNAs to monitor glioma patients and diagnose early recurrence in grade 2 and 3 gliomas.",[57,567,27,568],"miRNA","Biomarkers",[570,567,571],"glioma","biomarker","2024-09-23",{"date":574,"type":35},"2024-09-24",{"date":576,"type":35},"2024-04-25",{"date":578,"type":21},"2030-04-25",{"name":580,"class":113},"University Hospital, Caen",{"id":582,"slug":583,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":194},"100513369","phase-2-feasibility-of-individualized-model-guided-optimization-of-proton-beam-treatment-planning-in-patients-with-low-grade-glioma-100513369","NCT05964569","Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma","Prospective Phase II Trial to Assess Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma Multicentric, Prospective Interventional, Randomized, Observer Blind Two Arm (Active Control), Parallel Group Investigator-initiated Phase II Trial","INDIGO","Inclusion Criteria:\n\n* Age \\> 18 years\n* histologically proven low-grade glioma\n* indication for definitive or adjuvant radiotherapy\n* ability to understand character and personal consequences of the clinical trial\n* written informed consent\n\nExclusion Criteria:\n\n* previous cerebral irradiation\n* contraindication for contrast-enhanced MRI\n* neurofibromatosis\n* participation in another clinical trial with competing objectives",{"count":590,"type":21},120,[156],"Low-grade glioma (LGG) represent typically slowly growing primary brain tumors with world health organization (WHO) grade I or II who affect young adults around their fourth decade. Radiological feature on MRI is a predominantly T2 hyperintense signal, LGG show typically no contrast uptake. Radiotherapy plays an important role in the treatment of LGG. However, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. In order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible",[65],"2024-01-04",{"date":596,"type":35},"2024-01-05",{"date":598,"type":35},"2023-11-11",{"date":600,"type":21},"2028-11-11",{"name":602,"class":113},"University Hospital Heidelberg",{"id":604,"slug":605,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":611,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":618,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":20},"100528339","phase-2-binimetinib-in-patients-with-braf-fusion-positive-low-grade-glioma-or-pancreatic-cancer-perfume-100528339","NCT06159478","Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)","Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)","Perfume","Inclusion Criteria:\n\nInclusion criteria for both cohort A and B\n\n1. BRAF fusion or rearrangement is detected by reimbursed NGS-based cancer gene panel tests, cancer gene panel tests performed under advanced medical treatment, or clinical study (including liquid biopsy).\n2. Unresectable or recurrent\n3. No symptomatic brain metastasis, carcinomatous meningitis or spinal metastasis requiring surgical intervention or radiotherapy\n4. No cardiac effusion, pleural effusion, or ascites requiring treatment\n5. Not received anti-cancer drug within 14 days before registration, nor received other study drug (molecular targeting drug, immune therapy) within 21 days before registration\n6. Not received operation under general anesthesia within 28 days before registration\n7. Not received radiation therapy (including gamma knife, cyber knife) within 14 days before registration\n8. Left ventricular ejection fraction \\>= 50% by echocardiography or MUGA (multigated acquisition scan) within 28 days before registration\n9. Having all laboratory tests performed within 14 days before registration and the values are within the following range. Patients should not receive administration of G-CSF and\u002For blood transfusion within 14 days before the blood collection (1) Absolute neutrophil count \\>= 1.500\u002Fmm3 (2) Platelet count \\>= 10.0 X 10(4))\u002Fmm3 (3) Hemoglobin \\>= 8.0 g\u002FdL (4) Total bilirubin \\\u003C= 1.5 g\u002FdL (5) Aspartate aminotransferase (AST) \\\u003C= 100 U\u002FL (6) Alanine aminotransferase (ALT) \\\u003C= 100 U\u002FL (7) Serum creatinine \\\u003C= 1.5 mg\u002FdL\n10. Patients who are able to swallow orally administered medication.\n11. Consent to at least 30 days of contraception and limited egg donation (including egg retrieval for future egg transfer) after last administration of study drug for child-bearing status women. Consent to 90 days of contraception and limited sperm donation after last administration of study drug for men.\n12. Written informed consent (When registering patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian.)\n\n    Cohort A\n13. Histopathologically diagnosed as low-grade glioma, based on WHO classification of 2007, 2016 and 2021. The grade is WHO grade 1 or 2.\n14. Age at the time of registration is 12 years or older (When registering a patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian), and patients who are 12-17 years old have to be 40 kg or over in body weight. There is no limitation in body weight for patients who are 18 years or older.\n15. Lansky Performance Status (LPS) \\>= 70 for patients 12-15 years old Karnofsky Performance Status (KPS) \\>= 70 for patients 16 years or older\n16. Having measurable disease within 28 days before registration\n17. Patients suffice the following. (1) Having adequate initial treatment depending on the primary central nervous tumor including surgery if recommended treatment is available. (2) Neurologically stable.\n\n(3) Multiple lesion or dissemination is not detected with MRI at the registration.\n\n18\\) Not increased steroid for low-grade glioma within 14 days before registration and the dosage of steroid in equivalent to 50 mg prednisolone or less.\n\nCohort B 19) Histopathologically diagnosed as pancreatic cancer (histologically not specified).\n\n20\\) Having progression after at least one regimen of chemotherapy excluding adjuvant therapy.\n\n21\\) Age at the time of registration is 18 years or older. 22) Performance Status (ECOG) is 0 or 1 23) Having measurable disease within 28 days before registration detected by enhanced CT (Head, chest, abdominal, pelvic: under 5 mm in slice)\n\nExclusion Criteria:\n\n1. Active double primary cancer (but not \\[1\\]-\\[3\\]): \\[1\\] completely resected following cancers: basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, \\[2\\] gastrointestinal cancer curatively resected with ESD or EMR, and \\[3\\] other cancers with no recurrence for more than 5 years.\n2. Patients with symptomatic congestive heart failure of NYHA class II-IV or arrythmia (over grade 2) occurring in less than 6 months before registration.\n3. Patients with myocardial infarction or unstable angina occurring in less than 6 months before registration.\n4. Patients with corrected QT interval (QTcF) \\> 480 ms in ECG performed within 14 days before enrollment.\n5. Patients with infections requiring systemic treatment.\n6. Patients with uncontrolled hypertension (systolic blood pressure: over 150 mmHg or diastolic blood pressure: over 100 mmHg).\n7. Patients with history or findings of retinal vein occlusion (RVO) or having RVO risk factor (unstable glaucoma, ocular hypertension, hyperviscosity syndrome, hypercoagulability syndrome, etc.)\n8. Patients with history or complication of retinal degenerative disease other than RVO (central serous chorioretinopathy, retinal detachment, age-related macular degeneration, etc.)\n9. Patients with uncontrolled diabetes mellitis.\n10. Patients with venous thrombus (transient ischemic attack, stroke, massive deep vein thrombosis, pulmonary embolism, etc.) occurring in less than 3 months\n11. Patients who have neuromuscular disease with CK elevation (inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, etc.).\n12. Prior treatment with MEK inhibitors.\n13. Previous severe hypersensitive reaction to ingredient including binimetinib.\n14. Patients who are positive for either HIV antibody, HBs antigen, or HCV-RNA.\n15. Negative for HBs antigen, positive for HBs antibody or HBc antibody, and positive for HBV-DNA assay. (If it is less than or equal to the detection sensitivity, patients are not excluded)\n16. Patients with concomitant diseases that affect gastrointestinal function.\n17. Women who are pregnant, breastfeeding and need to continue breastfeeding in the future, and women who may be pregnant.\n18. Patients with psychiatric diseases or psychological symptoms interfering with participation in the trial.\n19. Patients who are deemed inappropriate for participation in the trial by the principal investigator or sub-investigator.","12 Years",{"count":613,"type":21},32,[156],"This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion\u002Frearrangement.",[27,617],"Pancreatic Cancer",[619,620,621],"BRAF fusion","BRAF rearrangement","Binimetinib","2023-12-06",{"date":624,"type":35},"2023-12-13",{"date":626,"type":35},"2023-03-29",{"date":628,"type":21},"2027-09-30",{"name":630,"class":631},"National Cancer Center, Japan","OTHER_GOV",{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":16,"minAge":611,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":653},"100515833","cest-in-low-grade-glioma-study-100515833","NCT05996653","CEST in Low-grade Glioma Study","A Multi-institutional Observational Study of CEST Imaging in Low-grade Glioma","Inclusion Criteria:\n\n1. Be at least 12 years of age;\n2. Diagnosed with:\n\n   1. Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based on any combination of histological, molecular, radiological, and\u002For clinical findings; or\n   2. Cohort B (post-surgical): IDH1\u002F2-mutant or IDH-wildtype (WT) low-grade glioma candidate for observation\n3. No contraindications to MRI;\n4. eGFR \\> 30 ml\u002Fmin;\n5. No prior chemotherapy or radiation therapy;\n6. No need for upfront treatment (surgery, chemotherapy, and\u002For radiation therapy)\n7. Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital\n\nExclusion Criteria:\n\n1. Need for upfront post-surgical treatment with either chemotherapy and\u002For radiation therapy\n2. Pregnancy",{"count":640,"type":21},100,[180],"Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that typically present in the younger population. This project proposes to use non-contrast metabolic \"Saturation Transfer\" (ST)-MRI to evaluate LGG tumour progression and aims to predict early changes in LGG. Early identification of LGG patients whose tumours will progress will permit early interventions. ST-MRI does not involve any intravenous injection of contrast and which acquires metabolic information not seen by standard MRI.",[27],"2023-08-10",{"date":646,"type":35},"2023-08-18",{"date":648,"type":35},"2022-08-12",{"date":650,"type":21},"2028-08-12",{"name":652,"class":113},"Sunnybrook Health Sciences Centre",2,{"id":655,"slug":656,"hasResults":11,"nctId":657,"briefTitle":658,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":660,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":663,"briefSummary":664,"conditions":665,"keywords":666,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":677,"locationsCount":194},"100386769","phase-2-radiotherapy-versus-radiotherapy-combined-with-temozolomide-in-high-risk-low-grade-gliomas-after-surgery-100386769","NCT04316039","Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery","Inclusion Criteria:\n\n1. Newly diagnosed supratentorial WHO grade II gliomas;\n2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;\n3. Karnofsky performance score (KPS) ≥ 60;\n4. No more than moderate neurologic symptoms and signs;\n5. The interval between surgery and randomization is less than 12 weeks;\n6. Have signed the consent form. -\n\nExclusion Criteria:\n\n1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system;\n2. Have received prior radiation therapy to the head and neck region;\n3. Have received prior chemotherapy;\n4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;\n5. Prior malignancy's disease-free survival less than 5 years;\n6. Have active infection;\n7. Patients are pregnant or breast-feeding. -","70 Years",{"count":662,"type":21},250,[156,127],"It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.",[27],[667,668,669,670],"low-grade glioma","High-risk","Radiotherapy","Temozolomide","2020-03-19",{"date":673,"type":35},"2020-03-20",{"date":675,"type":35},"2018-04-10",{"date":388,"type":21},{"name":678,"class":113},"West China Hospital"]