[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-grade-glioma-of-brain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-grade-glioma-of-brain":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,74,104,129,157,187],{"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":5},"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",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"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.","1 Year","21 Years",{"count":54,"type":22},30,[56],"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.",[59,29,30,60,61],"Glioma","Glioma, Malignant","Glioma Intracranial",[59,29,30,60,61,63],"18F-Fluciclovine","2026-04-24",{"date":66,"type":36},"2026-04-29",{"date":68,"type":22},"2026-07-29",{"date":70,"type":22},"2027-09",{"name":72,"class":43},"Children's Hospital of Philadelphia",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":73},"100635013","patient-voice-in-the-treatment-of-low-grade-gliomas-use-of-patient-reported-outcomes-vorasidenib-and-radiotherapy-compared-100635013","NCT07547163","Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared","LGG PRO's","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of IDH mutant, grade 2 glioma\n* Consent to treatment\n* Consent to the administration of PROM questionnaires\n\nExclusion Criteria:\n\n* Cognitive impairment or mental disability.\n* Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.\n* Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.\n* Language barriers.\n* Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.\n* Literacy issues: participants who are unable to read or write are excluded.\n* Non-adherence or poor cooperation.\n* Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.\n* Conditions that may influence questionnaire outcomes.\n* Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.","18 Years",{"count":83,"type":22},90,"OBSERVATIONAL","The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.\n\nTo evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.\n\nTo assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.",[59,87,30,88,89],"Glioma of Brain","Low Grade Gliomas","IDH Mutation",[91,92,88,93,94],"Patient Reported Outcomes","glioma","grade 2 glioma","IDH mutant","2026-04-17",{"date":97,"type":36},"2026-04-23",{"date":99,"type":36},"2025-04-23",{"date":101,"type":22},"2027-10",{"name":103,"class":43},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":19,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":73},"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":113,"type":22},40,[115],"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.",[29,31,30,118],"Pediatric Cancer",[120],"Interstitial Laser Therapy","2026-03-26",{"date":123,"type":36},"2026-04-01",{"date":125,"type":36},"2026-03-25",{"date":127,"type":22},"2031-01-01",{"name":42,"class":43},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":73},"100248194","measure-of-the-potential-evoked-by-electric-stimulation-100248194","NCT02509442","Measure of the Potential Evoked by Electric Stimulation","Pilot Study: Measure of the Potential Evoked With Electroencephalography and Electrocorticography by Electric Stimulation of the Brain During the Neurosurgery Awakened of the Infiltrative Glioma of Low Grade (OMS Type II)","PE&CE","Inclusion Criteria:\n\n* Patient carrier of a low-rank infiltrative glioma (OMS Type II) and presenting the indications to benefit from a surgical care in condition awakened for the first time.\n* Patient capable of understanding the nature, the purpose and the methodology of the research.\n* Having signed an informed consent writes before the inclusion in the research.\n* Membership or beneficiary of a national insurance scheme\n\nExclusion Criteria:\n\n* Systematic pathology with neurological appearance\n* Psychiatric disorders\n* History of psychotic disorders\n* History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology\n* Major protected by the law (supervision or guardianship)\n* Loss of liberty by court or administrative order","30 Years","50 Years",{"count":140,"type":22},12,[115],"This study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on the site of the CHU of Montpellier.\n\nThe objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses.\n\nHaving verified the eligibility of the patients and having obtained their consent, they will be included in the study. Before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. Before and after the surgical resection, the electrocorticography activity will be recorded.\n\nThe collected data will then be analyzed, after the operation. Analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.",[30],[145,146,147],"mapping brain functions","Direct electric stimulation (DES)","potential evoked","2025-09-25",{"date":150,"type":36},"2025-09-29",{"date":152,"type":36},"2015-07-22",{"date":154,"type":22},"2027-11",{"name":156,"class":43},"University Hospital, Montpellier",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":73},"100486124","phase-1-victory-vorasidenib-in-combination-with-tumor-specific-peptide-vaccine-for-recurrent-idh1-mutant-lower-grade-gliomas-100486124","NCT05609994","ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas","ViCToRy","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. IDH1R132H expression in primary tumor\n3. Clinical and\u002For radiographic, progressive Grade 2-3 glioma with greater than 2 cm of non-enhancing disease in one plane.\n4. 1st recurrence only\n5. Signed informed consent\n6. For females of child-bearing potential, negative serum pregnancy test at screening\n7. Women of childbearing potential and male participants must agree to practice contraception\n8. Karnofsky Performance Status (KPS) of ≥ 70\n9. Expected survival of ≥ 12 months\n10. Recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management\n11. Complete Blood Count (CBC)\u002Fdifferential with adequate bone marrow function as defined below within 2 weeks of enrollment:\n\n    1. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3\n    2. Platelet count ≥ 100,000 cells\u002Fmm3\n    3. Hemoglobin (Hgb) ≥ 10 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g\u002Fdl is acceptable.)\n12. Adequate renal function as defined below within 2 weeks of enrollment:\n\n    1. Blood urea nitrogen (BUN) ≤ 25 mg\u002Fdl\n    2. Creatinine ≤ 1.7 mg\u002Fdl\n13. Adequate hepatic function as defined below within 2 weeks of enrollment:\n\n    1. Bilirubin ≤ 2.0 mg\u002Fdl\n    2. Alanine transaminase (ALT) ≤ 3 x normal range\n    3. Aspartate aminotransferase (AST) ≤ 3 x normal range\n\nExclusion Criteria:\n\n1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years (e.g., carcinoma in situ of the breast, oral cavity, and cervix are all permissible)\n2. Metastases detected below the tentorium or beyond the cranial vault\n3. More than 1 cm X 1 cm of enhancing disease on gadolinium contrasted MRI imaging\n4. Severe, active co-morbidity, defined as follows:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization\n   2. Myocardial infarction within the last 6 months.\n   3. Known Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition (Note: human immunodeficiency virus \\[HIV\\] testing is not required for entry into this protocol. The need to exclude patients with Acquired Immunodeficiency Syndrome (AIDS) from this protocol is necessary because treatments involved in this protocol may be significantly immunosuppressive.)\n   4. Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.\n5. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug\n6. Patients with a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome)\n7. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted (Note: Patients with chronic HBV that is adequately suppressed by institutional practice will be permitted.)\n8. Patients with active gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the ingestion or gastrointestinal absorption of drugs administered orally (Note: Gastroesophageal reflux disease under medical treatment is allowed.)\n9. Patient taking any medications that are CYP3A or CYP2C9 substrates with a narrow therapeutic index (Note: Patients should be transferred to other medications before receiving the first dose of study drug.)\n10. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study\n11. Patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine®\n12. Allergy or hypersensitivity to tetanus vaccine or any component of the tetanus vaccine.\n13. Known hypersensitivity to any component of vorasidenib\n14. Prior therapy with mIDH1 targeted therapeutics\n15. Unable to undergo MRI imaging",{"count":165,"type":22},48,[167],"PHASE1","The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.",[30],[171,172,173,174,175,176,177,178,94],"low grade glioma","brain cancer","vorasidenib","peptide vaccine","immunotherapy","recurrent glioma","Katherine Peters","Pro00108636","2025-07-15",{"date":181,"type":36},"2025-07-18",{"date":179,"type":36},{"date":184,"type":22},"2029-08",{"name":186,"class":43},"Katy Peters, MD, PhD",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100554502","surgical-management-of-low-grade-glioma-100554502","NCT06499922","Surgical Management of Low Grade Glioma","Recent Advances in Surgical Management of Low Grade Glioma","Inclusion Criteria:\n\n* Patients diagnosed radiologically with low grade glioma\n\nExclusion Criteria:\n\n* patients not fit for surgery",{"count":195,"type":22},100,"To assess the morbidity and mortality in low grade glioma patients following surgical management.",[30],"NOT_YET_RECRUITING","2024-07-07",{"date":201,"type":36},"2024-07-15",{"date":203,"type":22},"2024-08",{"date":205,"type":22},"2026-07-01",{"name":207,"class":43},"Assiut University"]