[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-brain-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-brain-tumor":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,76,105,128,175,216,249],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100646523","phase-2-belvarafenib-for-cns-efficacy-in-patients-with-braf-altered-solid-tumors-100646523",false,"NCT07688356","Belvarafenib for CNS Efficacy in Patients With BRAF-Altered Solid Tumors","An Exploratory Phase 2 Study for Evaluating CNS Efficacy of Belvarafenib in Patients With BRAF-Altered Solid Tumors","Inclusion Criteria: (Applicable to Both Cohorts)\n\n1. Male or female patients aged 19 years or older.\n2. Histologically confirmed primary brain tumor or metastatic brain tumor.\n3. Documented BRAF mutation, including point mutations (e.g., V600E) or BRAF fusion mutations.\n4. Willing and able to provide written informed consent prior to participation in the study.\n5. Estimated life expectancy of at least 3 months.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n7. Adequate organ function demonstrated by laboratory assessments performed within 14 days prior to the first dose of study treatment, meeting all of the following criteria:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Platelet count ≥ 100 × 10⁹\u002FL\n   * PT\u002FINR and aPTT ≤ 1.5 × upper limit of normal (ULN)\n   * Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome)\n   * AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver metastases)\n   * Alkaline phosphatase ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver or bone metastases)\n   * Albumin ≥ 2.5 g\u002FdL\n   * Amylase ≤ 1.5 × ULN\n   * Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) \\> 50 mL\u002Fmin using the Cockcroft-Gault formula\n8. Women of childbearing potential (defined as women from menarche until 1 year after menopause unless permanently sterile) and men with partners of childbearing potential must agree to use highly effective contraception throughout the study and for 3 months after the last dose of Belvarafenib.\n\n   Women of childbearing potential must have a negative pregnancy test during screening unless surgically sterile.\n\n   Acceptable contraceptive methods include:\n   * Hormonal contraception\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Vasectomy or bilateral tubal occlusion\n   * Complete abstinence Barrier methods (e.g., male or female condoms); if barrier methods are used alone, the use of two complementary barrier methods is recommended.\n9. Additional Inclusion Criteria for Cohort 1 (Primary Brain Tumors) 1) Patients with BRAF-mutant primary brain tumors who meet at least one of the following conditions:\n\n   \\- No available or appropriate local treatment options (e.g., surgery or radiotherapy);\n   * Radiographic evidence of disease recurrence or progression following standard therapy (including surgery and\u002For chemoradiotherapy \\[CCRT\\]), with no further suitable standard treatment available;\n   * Standard treatment is considered inappropriate or unavailable in the investigator's judgment.\n10. Additional Inclusion Criteria for Cohort 2 (Metastatic Brain Tumors)\n\n\u003C!-- -->\n\n1. Patients with brain metastases from BRAF-mutant solid tumors.\n2. Patients with radiographic evidence of disease progression after receiving the standard treatment for the primary malignancy, or whose disease is refractory to conventional therapy, regardless of prior exposure to BRAF-targeted therapy, and who have no available or appropriate local treatment options (e.g., surgery or radiotherapy).\n3. At least one measurable intracranial lesion, with a maximum of five target lesions, as defined by the Response Assessment in Neuro-Oncology (RANO) criteria.\n\nExclusion Criteria: (Applicable to Both Cohorts)\n\n1. History of hypersensitivity to BRAF inhibitors or related compounds. Prior treatment with a BRAF inhibitor is permitted.\n2. Presence of hematologic malignancy or double primary malignancies at screening. The following second primary malignancies are permitted:\n\n   * Carcinoma in situ of the cervix successfully treated at least 1 year before enrollment;\n   * Papillary thyroid carcinoma treated with curative surgical resection;\n   * Completely resected cutaneous squamous cell carcinoma.\n3. Any of the following:\n\n   \\- Receipt of an investigational medicinal product within 28 days or within five half-lives (whichever is longer) before the first dose of study treatment;\n\n   \\- Major surgery within 28 days before the first dose of study treatment;\n   * Newly initiated or recently increased systemic corticosteroid therapy equivalent to ≥10 mg\u002Fday of prednisolone within 28 days before the first dose.\n   * Patients receiving a stable dose for at least 2 weeks or requiring continued corticosteroid treatment after surgery may be enrolled at the investigator's discretion;\n   * Current treatment with systemic immunosuppressive agents or anticipated need for continuous systemic immunosuppression during the study. Topical preparations, inhaled corticosteroids, ophthalmic preparations, and local injections are permitted;\n   * More than five prior systemic anticancer treatment regimens.\n4. Unresolved adverse events of CTCAE Grade ≥2 from previous anticancer therapy at screening, except alopecia.\n5. Any of the following cardiovascular conditions:\n\n   * Mean QTcF \\>440 msec;\n   * New York Heart Association (NYHA) Class III or IV heart failure;\n   * Cardiac metastasis;\n   * Uncontrolled electrolyte abnormalities (hyponatremia, hypokalemia, hypocalcemia, or hypomagnesemia);\n   * Within 6 months before the first dose: unstable angina, acute coronary syndrome (including myocardial infarction), uncontrolled arrhythmia (except sinus arrhythmia or adequately controlled atrial fibrillation for at least 30 days), symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack;\n   * Coronary angioplasty, coronary\u002Fperipheral artery bypass graft surgery, or coronary stent placement within 6 months before the first dose;\n   * History of congenital long QT syndrome or clinically significant CTCAE Grade ≥2 ventricular or atrial dysrhythmias.\n6. Any of the following ophthalmologic disorders:\n\n   \\- History or evidence at screening of retinal vein occlusion (RVO), central serous retinopathy (CSR), or neovascular macular degeneration;\n\n   \\- Intraocular pressure ≥21 mmHg with glaucoma.\n7. Current or prior interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring corticosteroid treatment.\n8. Uncontrolled hypertension.\n9. Uncontrolled infectious or neurologic disease, active infection requiring intravenous antibiotics, known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection.\n10. Inability to swallow oral tablets or any gastrointestinal condition that may interfere with the administration, absorption, or metabolism of Belvarafenib, including refractory nausea or vomiting, malabsorption syndrome, external biliary shunt, significant small bowel resection, clinically significant gastrointestinal bleeding, acute pancreatitis within 28 days before the first dose, or diverticulitis.\n11. Requirement for continuous treatment with CYP2C8 substrate medications (e.g., amodiaquine) or rifampin.\n12. Known or suspected substance abuse or alcohol abuse.\n13. Psychological, social, geographic, psychiatric, or congenital conditions that, in the investigator's judgment, would interfere with compliance with the study protocol or follow-up.\n14. Pregnant or breastfeeding women, or women of childbearing potential planning to become pregnant during the study.\n15. Any other medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make the participant unsuitable for study treatment.\n16. Additional Exclusion Criteria for Cohort 1 (Primary Brain Tumors) 1) New intracranial lesions identified within 12 weeks after prior brain radiotherapy when radiation necrosis cannot be reliably distinguished from tumor progression.\n17. Additional Exclusion Criteria for Cohort 2 (Metastatic Brain Tumors) 1) Clinically unstable disease due to uncontrolled primary malignancy. 2) Requirement for concurrent systemic anticancer therapy (e.g., chemotherapy, targeted therapy, or other systemic anticancer treatment) for extracranial disease during the study.","ALL","19 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Belvarafenib in patients with BRAF-altered primary brain tumors (Cohort 1) and metastatic brain tumors (Cohort 2). Eligible patients are those with a confirmed BRAF alteration identified by next-generation sequencing (NGS).\n\nPatients who meet the eligibility criteria will receive a detailed explanation of the study, including its purpose, procedures, potential benefits, and risks. Only patients who voluntarily provide written informed consent will be enrolled.\n\nAll enrolled patients will receive Belvarafenib monotherapy at a dose of 450 mg twice daily (BID). The study drug will be taken orally within 30 minutes after meals with at least 200 mL of water, preferably at approximately 12-hour intervals each day. One treatment cycle is defined as 28 consecutive days of continuous dosing without a planned treatment break. Patients will receive treatment for six cycles (approximately six months) as the initial treatment period. Treatment may be extended or discontinued earlier at the investigator's discretion based on clinical benefit, disease status, and tolerability.\n\nDuring the study, patients will undergo regular clinical evaluations, including physical examinations, vital sign assessments, laboratory tests, and monitoring for adverse events. Radiologic assessments using MRI and\u002For CT will be performed at scheduled intervals to evaluate tumor response and disease progression. The study aims to determine whether Belvarafenib can control tumor growth, delay disease progression, and improve clinical outcomes in patients with BRAF-altered brain tumors.\n\nIf treatment-related toxicities occur, dose reductions are permitted according to the protocol. The dose may be reduced from 450 mg BID to 300 mg BID, and subsequently to 200 mg BID, if clinically indicated. Temporary treatment interruption may also be implemented until toxicity resolves. If unacceptable toxicity persists despite dose modification, treatment will be permanently discontinued.\n\nStudy treatment may be discontinued if any of the following occurs: confirmed disease progression, unacceptable toxicity, withdrawal of informed consent, inability to comply with the study protocol, receipt of other anticancer therapies that may interfere with study outcomes, or if the investigator determines that continued treatment is no longer in the patient's best interest. However, if radiologic disease progression is observed but the investigator determines that the patient continues to derive clinical benefit, treatment beyond progression may be considered after discussion with the sponsor, with appropriate documentation of the rationale.\n\nAfter discontinuation of study treatment, patients will receive the most appropriate subsequent management, including best supportive care (BSC) or other anticancer therapies, as determined by the treating investigator. Follow-up assessments will continue according to the study protocol.\n\nThe primary objective of this study is to evaluate the efficacy of Belvarafenib in patients with BRAF-altered primary and metastatic brain tumors, while also assessing its safety profile. The results of this study are expected to provide important clinical evidence supporting the development of new treatment strategies for patients with BRAF-altered brain tumors.",[26,27],"Primary Brain Tumor","Metastatic Brain Tumor",[29,30,31,32,33,34,35,36],"Belvarafenib","Pan-RAF inhibitor","BRAF alteration","Primary brain tumor","Brain metastases","Central nervous system","Targeted therapy","Precision oncology","RECRUITING","2026-07-06",{"date":40,"type":41},"2026-07-08","ACTUAL",{"date":43,"type":41},"2026-06-15",{"date":45,"type":20},"2029-12-31",{"name":47,"class":48},"Samsung Medical Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":49},"100483520","longitudinal-prospective-study-of-neurocognition--neuroimaging-in-primary-bt-patients-100483520","NCT05576103","Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients","Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy","Inclusion Criteria:\n\n1. Patients 18 years or older\n2. Karnofsky performance status (KPS) ≥70\n3. Life expectancy of ≥1 year\n4. Primary brain tumor patients who will receive fractionated partial brain RT\n5. Able to complete neurocognitive assessments\n\nExclusion Criteria:\n\n1. Inability to undergo MRI with contrast\n2. Prior brain RT","18 Years","99 Years",{"count":60,"type":20},300,"OBSERVATIONAL","In this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain. Quantitative neuroimaging, radiation dose information, and directed neurocognitive testing will be acquired through this study to improve understanding of cognitive changes associated with radiation dosage to non-targeted tissue, and will provide the basis for evidence-based cognitive- sparing brain radiotherapy.",[26,64,65,66],"Glioma","Meningioma","Schwannoma","2026-06-09",{"date":69,"type":41},"2026-06-10",{"date":71,"type":41},"2015-01",{"date":73,"type":20},"2030-12",{"name":75,"class":48},"Jona Hattangadi-Gluth",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100338258","non-invasive-glioma-characterization-through-molecular-imaging-100338258","NCT03684109","Non-invasive Glioma Characterization Through Molecular Imaging","Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging","Inclusion Criteria:\n\n* Adults (≥18 year old)\n* Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his\u002Fher brain lesion.\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Patients unable to have MRI done",{"count":19,"type":20},[85],"NA","MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.",[64,88,26,89,90],"Brain Tumor","Malignant Glioma","Malignant Primary Brain Tumor",[92,93,94,95],"Non-invasive glioma characterization","Molecular Imaging","Isocitrate Dehydrogenase (IDH) Mutations","MRI-Based Sequencing","2026-04-14",{"date":98,"type":41},"2026-04-20",{"date":100,"type":41},"2019-01-25",{"date":102,"type":20},"2027-01-31",{"name":104,"class":48},"University of Miami",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":49},"100173728","assessment-of-eloquent-function-in-brain-tumor-patients-100173728","NCT01535430","Assessment of Eloquent Function in Brain Tumor Patients","Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors","Inclusion Criteria:\n\n* 19 years and older\n* Brain tumor in or near eloquent brain regions that is appropriate for attempted resection\n* Appropriate body habitus and mental status\u002Fcapacity to participate with non-invasive or invasive mapping\n* Benign or malignant intra-axial brain tumor\n* Primary or metastatic intra-axial brain tumor\n\nExclusion Criteria:\n\n* Any contraindication to MRI (i.e. implanted devices)\n* Inappropriate body habitus or mental status\u002Fcapacity to participate with non-invasive or invasive mapping in a safe and reliable manner\n* Declining to participate\n* Lacks capacity to understand the study or consent for themselves\n* Neurologic status which precludes testing (poor function- not testable)\n* Positive pregnancy test\n* End stage renal disease or severe renal dysfunction",{"count":113,"type":20},75,"Purpose of the study:\n\nAIM 1: Prospectively collect pre-operative \\[functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)\\] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.\n\nAIM 2: Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.",[26,27],[117,118],"brain mapping","brain tumor","2026-01-09",{"date":121,"type":41},"2026-01-13",{"date":123,"type":41},"2012-01-31",{"date":125,"type":20},"2027-12",{"name":127,"class":48},"University of Nebraska",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":49},"100447427","phase-1-chemo-immunotherapy-using-ibrutinib-plus-indoximod-for-patients-with-pediatric-brain-cancer-100447427","NCT05106296","Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer","Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer","Inclusion Criteria:\n\nDiagnosis:\n\n* Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma, glioblastoma, or another type of primary cancer of the central nervous system with no curative conventional therapy options available.\n* Metastatic disease is acceptable.\n* Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease.\n\nPatients must be able to swallow pills.\n\nLansky or Karnofsky performance status score must be ≥ 50%.\n\nAdequate renal function:\n\n* Creatinine clearance (CLcr) \\> 25 mL\u002Fmin (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient.\n\nAdequate liver function:\n\n* Alanine aminotransferase (ALT) ≤ 3-times upper limit of normal.\n* Aspartate aminotransferase (AST) ≤ 3-times upper limit of normal.\n* Total bilirubin ≤ 1.5-times upper limit of normal unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.\n\nAdequate bone marrow function:\n\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3 (independent of growth factor support).\n* Platelets ≥ 100,000\u002Fmm3 (independent of transfusion support).\n* Hemoglobin ≥ 8 g\u002FdL (independent of transfusion support).\n\nSeizure disorders must be well controlled on antiepileptic medication.\n\nPrior therapy:\n\n* Patients previously treated with chemotherapy drugs included in this protocol are eligible for enrollment.\n* At the time of Screening, patients must be at least 21 days from the administration of any investigational agent (other than indoximod) or prior cytotoxic therapy (including chemotherapy).\n* At the time of Screening, patients must be at least 28 days from administration of antibody-based therapies (e.g., bevacizumab), tumor-directed vaccines, or cellular immune therapies (e.g., T cells, NK cells, etc.).\n* At the time of Screening, patients must be at least 56 days from administration of tumor-directed therapies using infectious agents (e.g., viruses, bacteria, etc.).\n* At the time of Screening, patients must be at least 90 days from any radiation or proton therapy (all modalities, including radiosurgery) that targeted all sites of known disease.\n* There is no lock-out window for patients who were treated with focal radiation or focal proton therapy (all modalities, including radiosurgery) that did not target all disease sites, if at least one site of active tumor is expected to persist and\u002For grow.\n\nConcurrent anti-neoplastic therapy:\n\n* No investigational or commercial agents, including intrathecal drugs, other than that described by this clinical study protocol (GCC2020) may be administered with the intent to treat the patient's malignancy while they remain enrolled on this study.\n\nContraception, pregnancy, and breastfeeding:\n\n* Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study. Men must agree to not donate sperm during and for 3 months after the study.\n* Women who are pregnant or breastfeeding are ineligible for this study.\n* Patients who become pregnant while participating in this study will have to stop Study Therapy.\n\nPatients, or their parent for patients less than 18 years of age, must sign an Informed Consent Document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.\n\n.\n\nExclusion Criteria:\n\nPatients who are unable to swallow pills.\n\nPatients with known hypersensitivity to any drugs in the treatment plan.\n\nPatients with active autoimmune disease that requires systemic therapy.\n\n* Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema, asthma, etc.).\n\nPregnant or breastfeeding women.\n\nMajor surgery or a wound that has not fully healed within 4 weeks of Screening.\n\nKnown central nervous system lymphoma.\n\nPatients with active bleeding or history of thrombotic or hemorrhagic stroke, or intracranial hemorrhage, within 6 months prior to Screening; with the exception of retained blood products from recent prior uncomplicated surgery (e.g., tumor biopsy, debulking, or resection; VP shunt placement, etc.).\n\nRequires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon).\n\nRequires chronic treatment with strong CYP3A inhibitor drugs.\n\nClinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.\n\nPatients with baseline QTc interval of more than 470 msec at the time of Screening, and patients with congenital long QT syndrome.\n\nVaccinated with live, attenuated vaccines within 4 weeks of Screening.\n\nKnown history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection.\n\nAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib, indoximod, or chemotherapy, or put the study outcomes at undue risk.","3 Years","25 Years",{"count":138,"type":20},37,[140],"PHASE1","Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.\n\nThe GCC2020 trial is a prospective open-label phase 1 trial to determine the best safe dose of the BTK-inhibitor ibrutinib to use in combination with previously studied chemo-immunotherapy regimens comprised of the investigational IDO-inhibitor indoximod plus oral palliative chemotherapy for participants, age 6 to 25 years, with relapsed or refractory primary brain cancer. Those previously treated with indoximod-based therapy may be eligible, including prior treatment via the phase 2 indoximod study (GCC1949, NCT04049669), the now closed phase 1 study (NLG2105, NCT02502708), or any expanded access (compassionate use) protocols. Ibrutinib will be combined with either indoximod plus oral cyclophosphamide and etoposide (Regimen A) or indoximod plus oral temozolomide (Regimen B). No cross-over between these two regimens will be allowed. Dose-escalation cohorts will determine the best safe dose of ibrutinib for each of these regimens. This will be followed by expansion cohorts, using ibrutinib at the best safe dose for each regimen, to allow assessment of preliminary evidence of efficacy.",[143,144,145,26],"Ependymoma","Medulloblastoma","Glioblastoma",[147,148,149,150,151,152,153,154,155,118,156,157,158,159,160,161,162,163,164,165,166],"IDO","indoleamine 2,3-dioxygenase","indoximod","BTK","Bruton's Tyrosine Kinase","ibrutinib","immunotherapy","pediatric","childhood","brain cancer","glioblastoma","medulloblastoma","ependymoma","PNET","cyclophosphamide","etoposide","immune","central nervous system","CNS","temozolomide","2026-01-07",{"date":119,"type":41},{"date":170,"type":41},"2022-02-08",{"date":172,"type":20},"2028-09-30",{"name":174,"class":48},"Theodore S. Johnson",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":196,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":49},"100587627","hobscotch-ca-home-based-self-management-and-cognitive-training-changes-lives-in-brain-cancer-100587627","NCT06930846","HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)","HOBSCOTCH-CA","CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion\u002Fexclusion criteria. Inclusion Criteria 2. - 5. and Exclusion Criteria 1. - 3. will be confirmed by referring providers. Participants who learn about the study here and elsewhere will be instructed on how to confirm their eligibility with their provider.\n\nInclusion Criteria for CA Participant:\n\n1. 18 + years\n2. Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)\n3. Diagnosis of primary brain tumor with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT or MRI), confirmed by histopathological examination (Note: some patients being treated for meningioma may be treated with radiotherapy without need for initial histopathologic confirmation)\n4. Patients undergoing surgical and\u002For radiation therapy will have completed their treatment at least 3 months prior to being enrolled in trial (Note: patients receiving chemotherapy or other systemic therapy will be included)\n5. Stable on all CNS acting medications for one month prior to enrollment\n6. Subjective cognitive complaints\n7. Literate and proficient in English\n8. Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8\n\nExclusion Criteria for CA Participant:\n\n1. Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n2. Acute psychiatric disorder or substance abuse\n3. Patients with glioblastoma (GBM)\n\nInclusion Criteria for CA Participant Caregiver:\n\n1. Age 18 +\n2. Caregiver to a patient with a confirmed diagnosis of brain cancer\u002Ftumor survivor\n3. CA Subject has given permission for their caregiver to participate\n4. Literate and proficient in English\n5. Internet access (for Pre-HOBSCOTCH and Session 1)\n6. Telephone access (for Session 8)\n\nExclusion Criteria for CA Participant Caregiver:\n\n1. Significant visual impairment precluding reading or writing\n2. No reliable telephone or internet access",{"count":183,"type":20},125,[85],"The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer\u002Ftumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants.\n\nInvestigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.\n\nHOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a \"pre\" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).",[187,88,188,26,189,190,65,191,192,193,194,195],"Brain Cancer","Brain Neoplasms","Low-grade Glioma","Oligodendroglioma","Low Grade Astrocytoma","Cognitive Dysfunction","Memory Impairment","Memory Disorders","Memory Dysfunction",[197,198,199,200,201,202,203,204,205,206],"Brain cancer survivor","Brain tumor survivor","Cognition","Self-management","Cognitive training","Memory disorders","Cognitive remediation","Caregiver","Caregiver burden","Mindfulness","2025-11-18",{"date":209,"type":41},"2025-11-21",{"date":211,"type":41},"2025-11-03",{"date":213,"type":20},"2028-12",{"name":215,"class":48},"Dartmouth-Hitchcock Medical Center",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":16,"minAge":225,"maxAge":57,"enrollmentInfo":226,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100367605","neurocognitive-function-after-proton-therapy-in-children-and-adolescents-100367605","NCT04066465","Neurocognitive Function After Proton Therapy in Children and Adolescents","Neurocognitive Function \u002Fexecutive Functions After Proton Therapy in Children and Adolescents.","ELBE-ProKids","Indication: Patients with primary brain tumor\n\nInclusion Criteria:\n\n* all groups: Patients in childhood and adolescence between 8-18 years of age\n* all groups: no prior radiotherapy of the brain,\n* all groups: The patient is able to perform repeated neuropsychological tests (approx. 1 hour per examination),\n* all groups: corrected visual acuity not impaired below 80% or no subjective indication of visual acuity impairment,\n* all groups: corrected hearing not impaired or no subjective evidence of hearing impairment,\n* all groups: Patient is able to perform follow-up examinations,\n* all groups: written consent of the patient\u002Fparent or guardian.\n* Brain tumour groups with\u002Fwithout irradiation: Primary brain tumour\n* brain tumor groups with\u002Fwithout radiation: curative or long-term palliative intention of therapy\n* brain tumor groups with\u002Fwithout irradiation: life expectancy \\> 3 years\n* Irradiation group only: planned proton therapy with a local radiation dose of at least 40 Gy(RBE)\n\nExclusion Criteria:\n\n* Patients under 8 or over 18 years of age (We limit the study to children over 8 years of age due to the fact that executive functions mature very late.)\n* Brain metastases from extracerebral tumors\n* Patient receives intrathecal chemotherapy\n* pure palliative treatment concept\n* The patient is not able to perform repeated neuropsychological tests (approx. 1 hour per examination).\n* Chronic diseases that may affect the results of neurological EEG and neuropsychological examinations.\n* The patient is not in a position to perform follow-up examinations\n* no written consent of the patient \u002F parent or legal guardian\n* Participation in an intervention study whose procedures contradict those of the present study",true,"8 Years",{"count":227,"type":20},90,"Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted\u002Fanalysed\u002Fevalutated. In a second step, these results are to be compared with\n\n1. a group of children and adolescents who had only \u002Fexclusively had operative therapy and\n2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive\u002Fneurophysiology brain research approaches are applied that may potentially visualize even small \u002F subtle changes in mental activities\u002Fneurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.",[26],[88,231,232,233,234,235,236,237,238],"children and adolescents","neurocognitive function","neurocognitive or neuropsychological outcome","quality of life, LOQ","EEG","Neuropsychological Tests","Proton Therapy","Neurosurgical Treatment","2025-02-04",{"date":241,"type":41},"2025-02-06",{"date":243,"type":41},"2019-09-01",{"date":245,"type":20},"2027-12-31",{"name":247,"class":48},"Technische Universität Dresden",3,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":260,"studyType":61,"phases":4,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":275,"locationsCount":49},"100480722","biobank-and-register-of-patients-with-agresive-tumors-for-translational-and-analytical-research-100480722","NCT05539677","Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research","Analysis of the Immunogenetic Profile of Patients With Aggressive Course of Malignant Neoplastic Process Resistant to the Standard Treatment Approaches: a Translational Study","REGATA","Inclusion Criteria:\n\n* Signed inform consent\n* Histolgically verified solid tumour\n* Receiving systemic therapy for neoplasm\n* Has archival tumour tissue\n* Provide biosamples with living tumour tissue or blood samples for immunologic assessment\n\nExclusion Criteria:\n\n* Concurrent Lymphoprolipherative disorder\n* Patients after stem cell or bone marrow thansplantation\n* Incomplete informaton on previous cancer history or medical history\n* Patients with known primary immunodeficiency\n* Patients receiving immunosupressive therapy for concurrent illness\n* Pregnant patients","1 Year",{"count":259,"type":20},1000,"5 Years","The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies",[263,26,264,265,266,267,268],"Malignant Solid Tumors","Melanoma","Soft Tissue Sarcoma","Colorectal Cancer","Kidney Cancer","Prostate Cancer","2024-05-03",{"date":271,"type":41},"2024-05-06",{"date":273,"type":41},"1998-09",{"date":73,"type":20},{"name":276,"class":48},"N.N. Petrov National Medical Research Center of Oncology"]