[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-low-grade-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-low-grade-glioma":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100601419","phase-2-dabrafenib-and-trametinib-for-braf-v600-mutant-low-grade-gliomas-100601419",false,"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","ALL","12 Months","25 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"BRAF V600 Mutation","Low-grade Glioma","Low Grade Glioma of Brain","Recurrent Low Grade Glioma","RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2025-11-07",{"date":40,"type":22},"2032-03-31",{"name":42,"class":43},"University of California, San Francisco","OTHER",7,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"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.","2 Years",{"count":54,"type":22},40,[56],"NA","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.",[29,31,30,59],"Pediatric Cancer",[61],"Interstitial Laser Therapy","2026-03-26",{"date":64,"type":36},"2026-04-01",{"date":66,"type":36},"2026-03-25",{"date":68,"type":22},"2031-01-01",{"name":42,"class":43},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":70},"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":80,"type":22},132,[82,25],"PHASE1","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).",[85,86,87],"Low-Grade Glioma","Recurrent Low-Grade Glioma","Progressive Low-Grade Glioma",[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"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":121,"type":36},"2026-02-04",{"date":123,"type":36},"2021-06-21",{"date":125,"type":22},"2031-06",{"name":127,"class":43},"St. Jude Children's Research Hospital"]