[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cns-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cns-tumor":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,67,96,130,159,189,214,240],{"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":39,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100645242","phase-2-illuminate-a-clinical-study-evaluating-car-t-immune-cell-therapy-bcb-276-for-patients-with-diffuse-intrinsic-pontine-glioma-dipg-100645242",false,"NCT07680439","Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).","A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n* Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.\n* Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma\n* Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.\n* Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.\n* Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.\n* Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).\n* Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.\n* Participants of childbearing\u002Ffathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.\n* Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.\n* Participant must meet all other health and safety criteria defined in the study protocol.\n* Participant and\u002For authorized legal representative willing to provide consent\u002Fassent for study participation, including participation in the 15-year long term follow up period.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.\n* Evidence of metastatic disease.\n* Requirement of high or increasing doses of corticosteroids prior to participation.\n* Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.\n* Presence of an active malignancy other than DIPG.\n* Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.\n* Pregnant or breastfeeding.\n* Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.","ALL","1 Year","26 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG.\n\nTo participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study.\n\nBCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.",[27,28,29,30,31,32,33,34,35,36,37,38],"Diffuse Intrinsic Pontine Glioma","DIPG","Brain Tumor","CNS Tumor","Central Nervous System Tumor","Pediatric Cancer","Adult Cancer Patients","CNS Tumor, Childhood","CNS Tumor, Adult","Brainstem Glioma","Diffuse Midline Glioma","DMG",[40,41,42,43,44,45,46,47,48,49,50,51,52,53],"BCB-276","B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy","B7-H3","B7-H3 CAR T","B7-H3 CAR T Cells","Chimeric antigen receptor T cells","CAR T Cell","Immunotherapy","Cell Therapy","Pediatric","Children","Adolescent","Young Adult","Adult","NOT_YET_RECRUITING","2026-06-25",{"date":57,"type":58},"2026-07-02","ACTUAL",{"date":60,"type":21},"2026-07",{"date":62,"type":21},"2030-07",{"name":64,"class":65},"BrainChild Bio, Inc","INDUSTRY",6,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100580714","phase-1-a-study-of-phst001-in-advanced-solid-tumors-100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.","18 Years",{"count":76,"type":21},272,[78],"PHASE1","This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[81,82,83,84,30],"Advanced Solid Tumors","Ovarian Cancer","Endometrial Cancer","Cholangiocarcinoma","RECRUITING","2026-06-18",{"date":88,"type":58},"2026-06-23",{"date":90,"type":58},"2025-03-31",{"date":92,"type":21},"2031-04",{"name":94,"class":65},"Pheast Therapeutics",20,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":117,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100418695","phase-1-onc206-for-treatment-of-newly-diagnosed-recurrent-diffuse-midline-gliomas-and-other-recurrent-malignant-cns-tumors-100418695","NCT04732065","ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors","Open Label Phase 1 and Target Validation Study of ONC206 in Children and Young Adults With Newly Diagnosed or Recurrent Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors","PNOC023","Inclusion Criteria:\n\n* ARM A: Children and young adults with DMG, H3K27 altered (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) who completed at least one line of prior therapy. Prior treatment must have included focal radiation therapy and patients must be within 4-14 weeks from completion of radiation therapy to registration (patients must start treatment within 1 week from registration), have not started any other therapies post-radiation, and have no evidence of disease progression.\n* ARM A: Tumor tissue confirmation of DMG, H3K27 altered is mandatory and pathology must be consistent with a DMG, H3K27 altered.\n* ARM A: Participants must have recovered from all acute side effects of prior therapy.\n* ARM A: From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 4 weeks from antibodies and must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any biologic or small molecule 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 (these should be discussed with the study team)\n* ARM B: Newly diagnosed children and young adults (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) with a diagnosis of DMG, H3K27 altered are eligible, including spinal cord DMGs.\n* ARM B: Tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG, H3K27 altered.\n* ARM C: Children and young adults with DMGs (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) who have evidence of progression but have not been treated for this progression and are recommended to get re-irradiation.\n* ARM C: Patients must have undergone prior focal radiation therapy as part of their initial therapy and should be at least 6 months from prior radiation therapy. If timing is less than 6 months from prior focal radiation, these patients need to be discussed with the study chair(s).\n* ARM C: Tumor tissue confirmation is mandatory and pathology must be consistent with a DMG, H3K27 altered.\n* ARM C: Participants must have recovered from all acute side effects of prior therapy\n* ARM C: From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 4 weeks from antibodies and must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any biologic or small molecule 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 (these should be discussed with the study team)\n* ARM D: Children and young adults with recurrent primary malignant CNS tumors, excluding DMGs, (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) who have evidence of progression but have not been treated for this progression. Participants who received a surgical resection for that progression are eligible if surgery has no curative intent. These patients need to be discussed with the study team.\n* ARM D: Prior tumor tissue confirmation is mandatory and pathology from the primary tumor must be consistent with malignant CNS tumor (diagnosis of ependymoma is allowed).Tissue at the time of progression is not required.\n* ARM D: Participants must have recovered from all acute side effects of prior therapy\n* ARM D: From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 4 weeks from antibodies and must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any biologic or small molecule 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 (these should be discussed with the study team). Bevacizumab used for pseudoprogression does not require a wash out period.\n* TARGET VALIDATION: Newly diagnosed children and adults (2 years of age and above) with imaging consistent with a DMG, H3K27 altered are eligible.\n* TARGET VALIDATION: Children and young adults with recurrent primary malignant CNS tumors, including recurrent DMG, (2 years of age and above) who have evidence of progression but have not been treated for this progression.\n* TARGET VALIDATION: Participants must undergo tumor tissue collection as part of their standard of care\n* Participants who are receiving steroids must be on a stable or decreasing dose for at least 3 days prior to registration.\n* Peripheral absolute neutrophil count (ANC) \\>= neutrophil 1.0 g\u002Fl.\n* Platelet count \\>= 100 x 10\\^9\u002FL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Serum creatinine \\\u003C 1.5 Upper Limit normal (ULN) based on age and gender.\n* Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \\\u003C 3 x ULN or direct bilirubin \\\u003C 1.5 x ULN.\n* Alanine aminotransferase (ALT) \\\u003C= 3 x ULN.\n* Aspartate aminotransferase (AST) \\\u003C= 3 x ULN.\n* Patients with seizure disorder may be enrolled if seizure disorder is well controlled\n* The effects of ONC206 on the developing human fetus is unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception. Adequate methods include: hormonal or barrier method of birth control; or abstinence prior to study entry and for the duration of study participation. 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. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation\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* Participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required. Frozen tissue is also acceptable. Participants who previously enrolled on PNOC022 and provided adequate tissue, may not need to submit additional tissue - confirm with Study Chairs. Participants who do not meet this criterion may be discussed on a case-by-case basis with the Study Chairs.\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\n* Patients must be enrolled on PNOC COMP if PNOC COMP is open to accrual at the enrolling institution\n\nExclusion Criteria:\n\n* Arm A \\& B: For tumors that do not have a pontine or spinal cord epicenter the following specific exclusion criteria apply: Thalamic DMG and cerebellar, H3K27 altered that has undergone standard radiation without concurrent therapy (other than temozolomide).\n* Arm C \\& D: Patients who participated in trials investigating ONC201 in the upfront setting will not be eligible. Prior ONC201 exposure as part of PNOC022 or expanded access programs will be allowed.\n* Participants who are currently receiving another investigational drug are not eligible.\n* Participants who are currently receiving other anti-cancer agents are not eligible.\n* Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair.\n* Participants with uncontrolled infection.\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy.\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC206.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or family.\n* Any participants with illnesses that may affect absorption of ONC206.\n* Any participants on strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9 and 2C19 at least 14 days prior and throughout the study.","2 Years","21 Years",{"count":107,"type":21},208,[78],"This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called \"stress response\" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.",[111,112,113,114,115,116,30,31],"Diffuse Midline Glioma (DMG)","Glioblastoma","Recurrent Ependymoma","Recurrent Malignant Central Nervous System Neoplasm","Spinal Cord Glioma","World Health Organization (WHO) Grade III Glioma",[118],"H3 K27M-Mutant","2026-06-08",{"date":121,"type":58},"2026-06-11",{"date":123,"type":58},"2021-08-23",{"date":125,"type":21},"2027-07-31",{"name":127,"class":128},"Sabine Mueller, MD, PhD","OTHER",7,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":66},"100556713","phase-2-entrectinib-as-a-single-agent-in-upfront-therapy-for-children-3-years-of-age-with-ntrk123-or-ros1-fused-cns-tumors-100556713","NCT06528691","Entrectinib as a Single Agent in Upfront Therapy for Children \u003C3 Years of Age With NTRK1\u002F2\u002F3 or ROS1-FUSED CNS Tumors","PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children \u003C3 Years of Age With NTRK1\u002F2\u002F3 or ROS1-FUSED CNS Tumors (GLOBOTRK)","Inclusion Criteria: Screening Phase\n\n* Age from birth to age \\\u003C3 years at the time of diagnosis (date of surgical resection\u002Fbiopsy)\n* Participant with presumed newly diagnosed tumor in the supratentorial compartment\n* Patient must have measurable disease based on RAPNO criteria\n* ≤84 days since surgery (resection or biopsy)\n* Available tumor tissue for central review\n* Parent\u002Fguardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines\n\nExclusion Criteria: Screening Phase\n\n* Previous exposure to cytotoxic chemotherapy or radiotherapy\n\nInclusion Criteria: COHORT 1\n\n* Patients must be \\\u003C3 years of age at the time of diagnosis (date of surgical resection\u002Fbiopsy)\n* High-grade glioma (World Health Organization \\[WHO\\] grade III or IV) harboring NTRK1\u002F2\u002F3 or ROS1 gene fusions as determined by central pathology review\n* Patients must have measurable disease as defined by RAPNO criteria\n* Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation\n* ≤28 days since study screening\n* Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks\n* Neurologic deficits must have been stable for at least 7 days prior to study enrollment\n* Hemoglobin ≥ 8 g\u002FdL (without transfusion or erythropoietin use within 7 days prior to enrollment)\n* Platelet count ≥ 75,000\u002FµL (without transfusion within 7-day period prior to enrollment)\n* Absolute neutrophil count \\>1,000\u002FµL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x the upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 x ULN\n* Adequate renal function as defined by the following age-based serum creatinine concentrations:\n\n  * 0 to \\\u003C1 year: 0.5 mg\u002FdL\n  * 1 to \\\u003C2 years: 0.6 mg\u002FdL\n  * 2 to 3 years: 0.8 mg\u002FdL\n* Adequate cardiac function as defined by electrocardiogram (ECG) with Fridericia's corrected QT interval (QTc) ≤ 450 msec and echocardiogram left ventricular ejection fraction (LVEF) \\>50%\n* Screening and enrollment consents signed\n* Willingness and ability to comply with treatment plan, scheduled visits, laboratory tests and other study procedures\n\nInclusion Criteria: COHORT 2\n\n* Patients must be \\\u003C3 years of age at the time of diagnosis (date of surgical resection\u002Fbiopsy)\n* CNS tumor other than HGG harboring NTRK1\u002F2\u002F3 or ROS1 gene fusions as determined by central pathology review\n* Patients must have measurable disease as defined by RAPNO criteria\n* Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation\n* ≤28 days since study screening\n* Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks\n* Neurologic deficits must have been stable for at least 7 days prior to study enrollment.\n* Hemoglobin ≥ 8 g\u002FdL (without transfusion or erythropoietin use within 7 days prior to enrollment)\n* Platelet count ≥ 75,000\u002FµL (without transfusion within 7-day period prior to enrollment);\n* Absolute neutrophil count \\>1,000\u002FµL.\n* ALT and ALT ≤2.5x the upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 x ULN\n* Adequate renal function as defined by the following age-based serum creatinine concentrations:\n\n  * 0 to \\\u003C1 year: 0.5 mg\u002FdL\n  * 1 to \\\u003C2 years: 0.6 mg\u002FdL\n  * 2 to 3 years: 0.8 mg\u002FdL\n* Adequate cardiac function as defined by ECG with QTc ≤ 450 msec and echocardiogram LVEF \\>50%\n* Screening and enrollment consents signed\n* Willingness and ability to comply with treatment plan, scheduled visits, laboratory tests and other study procedures\n\nExclusion Criteria: COHORT 1 AND 2\n\n* Clinically significant medical disorder that could compromise the ability to tolerate study therapy or would interfere with the study procedures or results history\n* History of recent (3 months) symptomatic congestive heart failure\n* Known active, uncontrolled infection (bacterial, fungal, or viral)\n* Receiving enzyme inducing antiepileptic drugs (EIAEDs)\n* Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation\n* Receiving another investigational agent concurrently\n* Surgery within 2 weeks prior to treatment enrollment\n* Patients with known hypersensitivity to excipients of the investigational medicinal product\n* Active gastrointestinal disease or malabsorption disorder (e.g. Crohn's disease, ulcerative colitis, short-gut syndrome) that would impair drug absorption\n* Inability to take medication enterally","3 Years",{"count":139,"type":21},52,[24],"This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1\u002F2\u002F3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.",[143,30],"High Grade Glioma",[145,146,147,148,149,50],"CNS Tumors","High Grade Glioma with NTRK1\u002F2\u002F3 gene fusion","High Grade Glioma with ROS1 gene fusion","CNS tumor other than HGG harboring NTRK1\u002F2\u002F3 gene fusion","CNS tumor other than HGG harboring ROS1 gene fusion","2026-05-12",{"date":152,"type":58},"2026-05-13",{"date":154,"type":58},"2026-05-01",{"date":156,"type":21},"2032-11",{"name":158,"class":128},"St. Jude Children's Research Hospital",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100611150","self-administered-remote-neurological-examination-using-mobile-application-in-patients-with-brain-tumors-100611150","NCT07236840","Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors","NEMO","Inclusion Criteria:\n\n1. Diagnosis of brain tumors (histopathology\u002F radiology).\n2. Age \\> 5 years\n3. Patient or caregiver have access to an android smart phone and is able to install the mobile application.\n4. Expected survival more than 6 months during study accrual.\n5. Signing patient consent or parent consent\u002F child assent form (as appropriate).\n\nExclusion Criteria:\n\n1. Patient or caregiver is not reliable to follow instructions or use the mobile application.\n2. Patient with severe cognitive or psychiatric issues causing difficulty in using the app or follow instructions.\n3. Karnofsky Performance Status (KPS) or Lansky Performance Status LPS) \\\u003C50.\n4. Terminal illness with expected life expectancy (\\\u003C6 months).","5 Years",{"count":168,"type":21},600,"OBSERVATIONAL","The goal of this observational study is to evaluate the feasibility and accuracy of a self-administered remote neurological examination using the \"Iskhaa\" mobile application in patients with brain tumors aged above 5 years who are able to follow app-based instructions.\n\nThe main questions it aims to answer are:\n\n1. Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks.\n2. Development and validation of the AI model to detect functional changes and predict subsequent neurological deterioration.\n\nParticipants will:\n\n1. Use the Iskhaa mobile application to perform guided self-neurological examinations following pre-recorded video instructions.\n2. Complete EORTC QLQ-C30 and BN20 questionnaires for quality of life assessment.\n3. Record and upload videos (e.g., speech, walking, limb movements) using their mobile camera for analysis.\n4. In Phase 1 (onsite), 100 participants will use the app under supervision to ensure usability and accuracy.\n5. In Phase 2 (offsite), 500 participants will use the app independently at home for monthly self-assessments, with reminders and follow-up support.\n6. Continue routine clinic visits every 3-6 months and imaging every 6-12 months as per standard clinical care.\n\nThe study will compare app-recorded data with physician assessments to determine agreement and validity of remote neurological monitoring using artificial intelligence analysis.",[30,172,173,174],"Artificial Intelligence (AI)","Glioma","Digital Health",[176,177,178],"neurological examination","mobile application","brain tumors","2026-02-21",{"date":181,"type":58},"2026-02-24",{"date":183,"type":58},"2026-02-20",{"date":185,"type":21},"2027-11-05",{"name":187,"class":128},"Tata Memorial Centre",1,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":188},"100518888","artificial-intelligence-in-cns-radiation-oncology-100518888","NCT06036394","Artificial Intelligence in CNS Radiation Oncology","Artificial Intelligence in Radiation Oncology for CNS Tumors","AI-RAD","Inclusion Criteria:\n\n• Patients with CNS tumors treated with radiation in TMC between January 2010 and December 2022.\n\nExclusion Criteria:\n\n* RT treatment outside TMC.\n* Radiation planning not done in the treatment planning system (treated using clinical marking\u002F conventional simulator).",{"count":198,"type":21},6000,"Radiotherapy involves the use of high-energy X-rays, which can be used to stop the growth of tumor cells. Radiotherapy constitutes an essential avenue in the treatment of brain tumors. The modern techniques of radiotherapy involve radiation planning techniques guided by computer algorithms aimed to deliver high doses of radiation to the areas of brain with tumors and limit the doses to surrounding normal structures. Artificial intelligence uses advanced analytical processes aided by computational analysis, which can be undertaken on the medical images, and radiation planning process. We plan to use artificial intelligence techniques to automatically delineate areas of the brain with tumor and other normal structures as identified from images. Also, we will use artificial intelligence on the radiation dose images and other images done for radiation treatment to classify tumors with good or bad prognoses, identify patients developing radiation complications, and detect responses after treatment.",[30],[202,173,203,204,205],"Brain tumor","Radiation Oncology","Artificial Intelligence","Machine learning","2025-04-08",{"date":208,"type":58},"2025-04-09",{"date":210,"type":58},"2023-09-13",{"date":212,"type":21},"2028-09",{"name":187,"class":128},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":105,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100350071","phase-1-inform2-study-uses-nivolumab-and-entinostat-in-children-and-adolescents-with-high-risk-refractory-malignancies-100350071","NCT03838042","INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies","INFORM2 Exploratory Multinational Phase I\u002FII Combination Study of Nivolumab and Entinostat in Children and Adolescents With Refractory High-risk Malignancies (INFORM2-NivEnt)","Inclusion Criteria:\n\n* Children and adolescents with refractory\u002Frelapsed\u002Fprogressive high-risk\n\n  * CNS tumors: medulloblastoma, ependymoma, ATRT, ETMR, pediatric high grade glioma (including DIPG) or other pediatric embryonal CNS tumors OR\n  * solid tumors: neuroblastoma, nephroblastoma, rhabdoid tumor, embryonal or alveolar rhabdomyosarcoma, other embryonal small round blue cell tumors including pediatric type (bone) sarcoma or other pediatric type solid tumors OR\n  * Children and adolescents with newly diagnosed high grade glioma (HGG) in the context of a constitutional mismatch repair deficiency syndrome after maximum safe surgical resection with no established standard of care treatment option with curative intention available. In addition in France: ineligible to radiotherapy\n* No standard of care treatment available\n* Age at registration ≥ 2 to ≤ 21 years\n* Molecular analysis for biomarker identification (SNV load, MYC\u002FN amplification, high TILs or TLS positive) in laboratories complying with DIN EN ISO\u002FIEC 17025 or similar via INFORM molecular diagnostic platform or equivalently valid molecular pipeline\n* Biomarker determined using whole exome sequencing (SNV load), whole genome- or whole exome sequencing (MYC\u002FN amplification), IHC (high TILs or TLS positive)\n* In case molecular analysis was not performed via INFORM Registry molecular pipeline: transfer of molecular data (whole exome sequencing)\n* Time between biopsy\u002Fpuncture\u002Fresection of the current refractory\u002Frelapsed\u002Fprogressive tumor and registration ≤ 24 weeks. In patients receiving therapy not impacting biomarker stratification, time between biopsy\u002Fpuncture\u002Fresection of the current refractory\u002Frelapsed\u002Fprogressive tumor and registration of ≤ 36 weeks is allowed\n* Disease that is measurable as defined by RANO criteria or RECIST v1.1 (as appropriate).\n* Life expectancy \\> 3 months, sufficient general condition score (Lansky ≥ 70 or Karnofsky ≥ 70). Transient states like infections requiring antibiotic treatments can be accepted, and also stable disabilities resulting from disease\u002Fsurgery (hemiparesis, amputations etc.) can be accepted and will not be considered for Lansky\u002FKarnofsky assessments.\n* Laboratory requirements:\n\n  * Hematology:\n\n    * absolute granulocytes ≥ 1.0 × 109\u002Fl (unsupported)\n    * platelets ≥ 100 × 109\u002Fl \\& stable\n    * hemoglobin ≥ 8 g\u002Fdl or ≥ 4.96 mmol\u002FL\n  * Biochemistry:\n\n    * Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n    * AST(SGOT) ≤ 3.0 x ULN\n    * ALT(SGPT) ≤ 3.0 x ULN\n    * serum creatinine ≤ 1.5 x ULN for age\n* ECG: normal QTc interval according to Bazett formula \\\u003C 440ms\n* Patient is able to swallow oral study medication\n* Ability of patient and\u002For legal representative(s) to understand the character and individual consequences of clinical trial\n* Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active women of childbearing potential must agree to use acceptable and appropriate contraception during the study and for at least 6 months after the last study treatment administration. Sexually active male patients must agree to use a condom during the study and for at least 3 months after the last study treatment administration.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* Before patient screening and registration, written informed consent, also concerning data and blood transfer, must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n* No prior therapy with the combination of immune checkpoint inhibitors and HDACi\n* Phase I: molecular analysis performed and biomarker status known (mutational load, high TILs or TLS positive AND MYC(N) amplification status).\n* Phase II: molecular analysis performed, biomarker status known (mutational load, high TILs or TLS positive AND MYC(N) amplification status) and stratification according to the following criteria:\n\n  * Group A: high mutational load (defined as \\> 100 somatic SNVs\u002Fexome) based on whole exome sequencing OR\n  * Group C: Focal MYC(N) amplification based on whole genome sequencing or whole exome sequencing ot ATRT-MYC subgroup OR\n  * Group E: high TILs or TLS positive (defined as cells per mm² \\> 600 or presence of tertiary lymphoid structure) based on IHC analysis.\n\nExclusion Criteria:\n\n* Patients with CNS tumors or metastases who are neurologically unstable despite adequate treatment (e.g. convulsions).\n* Patients with low-grade gliomas or tumors of unknown malignant potential are not eligible\n* Evidence of \\> Grade 1 recent CNS hemorrhage on the baseline MRI scan.\n* Participants with bulky CNS tumor on imaging are ineligible; bulky tumor is defined as:\n\n  * Tumor with any evidence of uncal herniation or severe midline shift\n  * Tumor with diameter of \\> 6 cm in one dimension on contrast-enhanced MRI\n  * Tumor that in the opinion of the investigator, shows significant mass effect\n* Previous allogeneic bone marrow, stem cell or organ transplantation\n* Diagnosis of immunodeficiency\n* Diagnosis of prior or active autoimmune disease\n* Evidence of interstitial lung disease\n* Any contraindication to oral agents or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the investigator, would preclude adequate absorption.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies). Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \\[qualitative\\]). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBc Ab\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Clinically significant, uncontrolled heart disease\n* Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.\n* Any anticancer therapy (e.g., chemotherapy, HDACi (including valproic acid), DNA methyltransferase inhibitors, other immunotherapy, targeted therapy, biological response modifiers, endocrine anticancer therapy or radiotherapy) within 2 weeks or at least 5 half- lives (whichever is longer) of study drug administration.\n* Radiologically confirmed radiotherapy induced pseudoprogression in CNS tumors\n* Traditional herbal medicines; these therapies are not fully studied and their use may result in unanticipated drug-drug interactions that may cause or confound the assessment of toxicity. As part of the enrollment\u002Finformed consent procedures, the patient 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 patient is considering a new over-the- counter medicine or herbal product. For information on CYP substrates and P-gp inhibitors or inducers see section 5.8.\n* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form (including benzamide) of the investigational medicinal product\n* Participation in other ongoing clinical trials.\n* Pregnant or lactating females.\n* Presence of underlying medical condition (e.g. gastrointestinal disorders or electrolyte disturbances) that in the opinion of the Investigator or Sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and\u002For study therapy, or confound the ability to interpret the tolerability of combined administration of entinostat and nivolumab in treated subjects\n* Patients receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 5 mg\u002Fm2\u002Fday prednisone equivalent) may be approved after consultation with the Sponsor. No patient will be allowed to enroll in this trial more than once.",{"count":222,"type":21},91,[78,24],"The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory\u002Frelapsed\u002Fprogressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).",[30,226],"Solid Tumor",[228,229],"high-risk solid tumors","high-risk CNS tumors","2024-02-05",{"date":232,"type":58},"2024-02-07",{"date":234,"type":58},"2020-05-26",{"date":236,"type":21},"2027-06-30",{"name":238,"class":128},"University Hospital Heidelberg",14,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":247,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":248,"targetDuration":17,"studyType":169,"phases":4,"briefSummary":250,"conditions":251,"keywords":254,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":188},"100514760","development-of-asian-consortium-for-data-collection-and-clinical-trial-of-cns-tumors-100514760","NCT05982691","Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors","National Cancer Center Korea","Inclusion Criteria:\n\n* A patient who was diagnosed with CNS GCT and agreed to participate in the research between 2022-2027.\n\n  * Patients diagnosed between 2016-2022 can be enrolled if the participating institute has IRB approval for recruiting these patients as separate IRB document (Seoul Asan Hospital) or by comprehensive IRB document (Singapore NCC, Taiwan Medical University), or by recruitment on the basis of acquirement of the consent form for research (NCC, Korea).\n\n    * The age at the time of diagnosis is 0\\\u003C ≤40 years\n\n      * A patent who has been diagnosed with the relevant tumor via an operation or a biopsy ⑤ In the case of CNS germinoma, a biopsy may not have been performed on a patient. In this case, the patient may register as germinoma if he or she meets the following criteria: -Germinoma is strongly suspected radiologically, and a tumor marker from serum or cerebrospinal fluid (CSF) has not increased above the institute's reference normal value; -Germinoma is suspected radiologically, and a tumor marker from serum or CSF has elevated above the institute's reference normal value (tumor markers may be AFP or hCG)\n\nExclusion Criteria:\n\n① The patient or the guardian of the patient did not consent to participate.",true,{"count":249,"type":21},400,"\\\u003CPurpose of the Research\\>\n\n* Primary Establishing an Asian consortium to establish a database of pediatric CNS tumors in the prospective manner The target disease of this research focuses on pediatric tumors, and initially the registration of patients with CNS GCT will begin first.\n* Secondary Developing clinical protocols for pediatric CNS tumors based in Asia\n\n\\\u003CDuration of Research Participation\\> Registration period for research subjects: 2022-08-01 - 2027-12-31 Duration of medical records to be utilized: to 2030-12-31 Total projected duration of research: IRB approved to 2032-12-31 Interim assessment of data quality and integrity: 6 Mo after Data collection Evaluation for the Adaptation of Protocols: 1 and 2 years after the initiation of the study Analysis of Quality of Life and other questionnaires: 3 and 5 years Interim Analysis of all data: 5 years (2027) Final analysis of treatment outcome: 2032",[252,30,253],"CNS Germinoma","Asian Consortium",[255,30,253],"CNS germinoma","2023-08-07",{"date":258,"type":58},"2023-08-08",{"date":260,"type":58},"2022-08-05",{"date":262,"type":21},"2032-12-31",{"name":264,"class":265},"National Cancer Center, Korea","OTHER_GOV"]