[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-glioma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,67,92,128,149,187,217,242,263,283,307,327],{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100324915","phase-1-panitumumab-irdye800-in-diagnosing-participants-with-malignant-glioma-undergoing-surgery-100324915",false,"NCT03510208","Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery","Phase I\u002FII, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures","Inclusion Criteria:\n\n1\\) One of the following:\n\n1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma\n2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma\n\n   2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and\u002For participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.\n\n   3\\) Participant age ≥ 18 years.\n\n   4\\) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n\nExclusion Criteria:\n\n1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.\n2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.\n3. History of infusion reactions to monoclonal antibody therapies\n4. Pregnant or breastfeeding.\n5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).\n6. Any of the following lab values:\n\n   1. Platelet count \\\u003C 75,000\u002Fmm3\n   2. TSH ≥ 13 micro International Units\u002FmL.\n   3. Magnesium, potassium, or calcium \\\u003C each respective upper limit of normal\n   4. Serum creatinine \\> 1.5 times upper limit of normal\n7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n9. Participants not deemed by PI to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here.","ALL","18 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The phase I\u002FII trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.",[27,28],"Malignant Brain Neoplasm","Malignant Glioma","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2018-05-16",{"date":37,"type":20},"2026-11",{"name":39,"class":40},"Stanford University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100628937","phase-1-retifanlimab-with-or-without-difluoromethylornithine-for-the-treatment-of-progressive-high-grade-gliomas-100628937","NCT07468136","Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas","Phase I\u002FIIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of high-grade glioma, including any of the following:\n\n  * Glioblastoma, IDH-wild type (WT)\n  * Grade 3 or 4 IDH1\u002F2 mutant astrocytoma or\n  * Grade 3 oligodendroglioma\n  * Any prior grade 2 astrocytoma or oligodendroglioma that is suspected to have recurred at a higher grade\n  * Other high-grade glioma\n* Plan for surgical resection as part of routine clinical care\n* Radiographic disease progression, with or without tissue confirmation\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 and Karnofsky Performance Status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent for the current study\n* Willing to provide consent for the Neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples\n* Ability to complete forms by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Uncontrolled intercurrent illness that by the judgement of the investigator would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the regimens including, but not limited to:\n\n  * ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy\n  * current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids\n  * active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) ≤ 2 years prior to registration\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements (e.g., drug addiction)\n  * concurrent active Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable hepatitis B virus \\[HBV\\] deoxyribonucleic acid \\[DNA\\]) and Hepatitis C virus (defined as anti-hepatitis C virus \\[HCV\\] antibody \\[Ab\\] positive and detectable HCV ribonucleic acid \\[RNA\\]) infection\n\nEXCEPTIONS:\n\n* Patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive) must have completed at least 4 weeks of HBV antiviral therapy, and the HBV viral load must be undetectable at the time of registration\n* Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment ≥ 4 weeks prior to registration.\n\n  * NOTE: Patients without symptoms or prior history do not require testing prior to registration\n\n    * Co-morbid systemic illnesses or other severe concurrent disease that would make the patient inappropriate for entry into the study or interfere with proper assessment of safety and toxicity\n    * History of myocardial infarction ≤ 6 months prior to registration or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n    * Active autoimmune disease that has required systemic treatment (other than replacement therapy) ≤ 1 year prior to registration\n    * History of allogeneic stem cell transplant\n    * Receiving any other investigational agent with therapeutic intent\n    * Participants who are unable to swallow the DFMO solution or who are at risk for impaired absorption of oral medication.\n* NOTE: This restriction includes, but is not limited to, refractory vomiting, gastric resection\u002Fbypass, and duodenal\u002Fjejunal resection\n\n  * Patients with known hypersensitivity or allergy to DFMO or retifanlimab\n  * Contraindication to MRI or administration of gadolinium",{"count":50,"type":20},33,[23,24],"This phase I\u002FII trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and\u002For effective in treating patients with progressive high grade glioma.",[54,55,56,57,58,28],"Anaplastic Oligodendroglioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Diffuse Astrocytoma","Glioblastoma, IDH-Wildtype","2026-06-23",{"date":61,"type":33},"2026-06-24",{"date":59,"type":33},{"date":64,"type":20},"2030-10-25",{"name":66,"class":40},"Mayo Clinic",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100446866","phase-1-a-study-of-the-drug-selinexor-with-radiation-therapy-in-patients-with-newly-diagnosed-diffuse-intrinsic-pontine-dipg-glioma-and-high-grade-glioma-hgg-100446866","NCT05099003","A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)","A Phase 1\u002F2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)","Inclusion Criteria:\n\n* PRE ENROLLMENT: Patients must be =\\\u003C 25 years of age at the time of enrollment on APEC14B1 part A central nervous system (CNS)\u002Fhigh grade glioma (HGG) pre-enrollment eligibility screening\n\n  * Please note:\n\n    * This required age range applies to pre-enrollment eligibility for all HGG patients. Individual treatment protocols may have different age criteria.\n    * Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are \\>= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).\n* PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG\n\n  * Please note: there are specific radiographic criteria for DIPG patient enrollment on ACNS1821 (Step 1)\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n* PRE ENROLLMENT:\n\n  * For patients with non-pontine tumors: Patients and\u002For their parents or legal guardians must have signed informed consent for eligibility screening on APEC14B1 Part A.\n  * For patients with DIPG: Patients and\u002For their parents or legal guardians must have signed informed consent for ACNS1821.\n  * Note: As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n* PRE ENROLLMENT:\n\n  * For patients with non-pontine tumors only, the specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 ASAP, preferably within 5 calendar days of definitive surgery\n* STEP 1: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of enrollment\n* STEP 1: Patients must have newly-diagnosed DIPG or HGG (including DMG).\n* STEP 1: Stratum DIPG (Closed with Amendment #4)\n\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n  * Patients with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons on at least 1 axial T2 weighted image, are eligible. No histologic confirmation is required.\n  * Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2\u002F3 of the pontine cross-sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma not otherwise specified \\[NOS\\], and\u002For H3 K27M-mutant) by institutional diagnosis.\n* STEP 1: Stratum DMG (with H3 K27M mutation) (Closed with Amendment #4)\n\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n  * Patients must have newly-diagnosed non-pontine H3 K27M-mutant HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1\n  * Note: Patients need not have either measurable or evaluable disease, i.e., DMG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment. For rare H3 K27M-mutant HGG in non-midline structures (e.g., cerebral hemispheres), these patients will be considered part of Stratum DMG.\n* STEP 1: Stratum HGG (without H3 K27M mutation)\n\n  * Patients must have newly-diagnosed non-pontine H3 K27M-wild type HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1\n  * Please note:\n\n    * Patients who fall in this category and who are \\>= 18 years of age are not eligible due to another standard-of-care regimen (radiation\u002Ftemozolomide) that is available\n    * Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment\n* STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C16 years of age. Patients 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* STEP 1: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to step 1 enrollment)\n* STEP 1: Platelet count \\>= 100,000\u002FuL (transfusion independent) (within 7 days prior to step 1 enrollment)\n* STEP 1: Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to step 1 enrollment)\n* STEP 1: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to step 1 enrollment) or\n\nA serum creatinine based on age\u002Fsex as follows (within 7 days prior to step 1 enrollment):\n\n* Age \u002F Maximum Serum Creatinine (mg\u002FdL)\n\n  * 1 to \\\u003C 2 years \u002F male: 0.6; female: 0.6\n  * 2 to \\\u003C 6 years \u002F male: 0.8; female: 0.8\n  * 6 to \\\u003C 10 years \u002F male: 1; female: 1\n  * 10 to \\\u003C 13 years \u002F male: 1.2; female: 1.2\n  * 13 to \\\u003C 16 years \u002F male: 1.5; female: 1.4\n  * \\>= 16 years \u002F male: 1.7; female: 1.4\n\n    * STEP 1: Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age\n    * STEP 1: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n    * STEP 1: Serum amylase =\\\u003C 1.5 x ULN\n    * STEP 1: Serum lipase =\\\u003C 1.5 x ULN\n    * STEP 1: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination.\n    * STEP 1: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n    * STEP 1: Patients must be enrolled and protocol therapy must begin no later than 31 days after the date of radiographic diagnosis (in the case of non-biopsied DIPG patients only) or definitive surgery, whichever is the later date (Day 0).\n\nFor patients who have a biopsy followed by resection, the date of resection will be considered the date of definitive diagnostic surgery. If a biopsy only was performed, the biopsy date will be considered the date of definitive diagnostic surgery.\n\nExclusion Criteria:\n\n* STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications.\n* STEP 1: Patients who are currently receiving another investigational drug are not eligible.\n* STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.\n* STEP 1: Patients \\>=18 years of age who have H3 K27M-wild type HGG.\n* STEP 1: Patients who have an uncontrolled infection.\n* STEP 1: Patients who have received a prior solid organ transplantation.\n* STEP 1: Patients with grade \\> 1 extrapyramidal movement disorder.\n* STEP 1: Patients with known macular degeneration, uncontrolled glaucoma, or cataracts.\n* STEP 1: Patients with metastatic disease are not eligible; MRI of spine with and without contrast must be performed if metastatic disease is suspected by the treating physician.\n* STEP 1: Patients with gliomatosis cerebri type 1 or 2 are not eligible, with the exception of H3 K27M-mutant bithalamic tumors.\n* STEP 1: Patients who are not able to receive protocol specified radiation therapy.\n* STEP 1:\n\n  * Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.\n  * Lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk.\n  * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.\n  * Sexually active patients of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control (including a medically accepted barrier method of contraception, e.g., male or female condom) for the duration of their study participation and for 90 days after the last dose of selinexor. Abstinence is an acceptable method of birth control.","12 Months","21 Years",{"count":77,"type":20},132,[23,24],"This phase I\u002FII trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.",[28],"2026-06-16",{"date":83,"type":33},"2026-06-17",{"date":85,"type":33},"2022-05-31",{"date":87,"type":20},"2027-06-30",{"name":89,"class":90},"National Cancer Institute (NCI)","NIH",127,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100461787","phase-1-safety-study-of-the-repeated-opening-of-the-blood-brain-barrier-with-the-sonocloud-device-to-treat-malignant-brain-tumors-in-pediatric-patients-100461787","NCT05293197","Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients","Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration","SONOKID","Inclusion Criteria:\n\n* patient aged ≥ 5 years old and \\\u003C 18 years old\n* patient able to receive sonications and perform MRI studies without sedation\n* diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma)\n* recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed)\n* indication of treatment with carboplatin, validated in multidisciplinary meeting\n* Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients \\\u003C 16 years old) \\> 50% (a patient with a performance status score altered by a motor deficit due to tumor infiltration will be allowed to be included)\n* no threat of brain herniation or uncontrolled intracranial hypertension\n* corticosteroids treatment ≤ 1mg\u002Fkg\u002Fday\n* neutrophils \\> 1.5 x 109\u002FL\n* platelets \\> 100 x 109\u002FL\n* total bilirubin \\\u003C 1.5x upper limit of normal, AST et ALT \\\u003C 2.5x upper limit of normal\n* serum creatinin \\\u003C 1.5x upper limit of normal for the age or creatinine clairance \\>70mL\u002Fmin\u002F1.73m2 (EDTA method or 24h urine)\n* coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)\n* no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria\n* no healed wound on the scalp\n* covered by health insurance\n* for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control\n* written consent signed by the patient (if possible) and his parents or legal representatives.\n\nExclusion Criteria:\n\n* weight \\\u003C15kg\n* significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion\n* antineoplastic treatment other than carboplatin taken at the same time or stopped since less than:\n\n  * 6 weeks for nitrosoureas\n  * 1 month for temozolomide\n  * 1 month for bevacizumab\n  * 5 half-lives for tyrosin kinase inhibitors\n  * 3 weeks for any other chemotherapy\n\nfor the first sonication session\n\n* radiotherapy during the last 6 weeks\n* any other cancer treated during the last 5 years\n* any other uncontrolled disease or active infection\n* any other co-morbidity that could compromise participation to the study (in the judgement of the clinical investigator)\n* any anatomical particularity (skull thickness, thin skin) that could compromise a safe implantation of the device and\u002For compromise the quality of the treatment (in the judgement of the clinical investigator)\n* implanted defibrillator\u002Fpacemaker, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip\n* any contraindication to general anesthesia\n* any contraindication to MRI or known allergy to gadolinium or other MRI contrast agent\u002F\n* any contraindication to ultrasound contrast agent:\n\n  * allergy to the active substance or any excipient\n  * acute coronary syndrome or uncontrolled ischemic heart disease\n  * chronic heart failure or history of acute heart failure or heart failure grade III or IV\n  * treatment with dobutamine\n  * severe pulmonary arterial hypertension\n  * uncontrolled systemic hypertension\n  * respiratory distress syndrome\n* carboplartin hypersensitivity\n* treatment with phenytoin or fosphenytoin\n* earlier vaccination with attenuated alive vaccine\n* diminished auditory acuity ≥ grade 3 on CTCAE classification\n* history of thermoregulation disorder\n* impossibility of a rigorous medical follow-up due to geographic, social or mental reasons\n* pregnant and lactating women\n* contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs\n* contemporaneous treatment possibly toxic for the central nervous system. The following treatments are excluded if taken less than 5 half-lives before the ultrasound session (unknown toxicity in case of BBB disruption) :\n\n  * benzodiazepine (or any sedative or hypnotique drug)\n  * antihistamine\n  * proconvulsant drugs\n  * butyrophenone, phenothiazine, or any \"conventional\" antipsychotic drug\n  * barbiturate\n  * MAO inhibitor\n  * anticholinergic\n  * anticoagulant\n* any contemporaneous treatment that, in the judgement of the clinical investigator, could induce brain toxicity after BBB disruption","5 Years","17 Years",{"count":103,"type":20},24,[23],"Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin.\n\nStudy hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.",[107,28,108],"Malignant Brain Tumor","Embryonal Tumor",[110,111,112,113,114,115,116,117],"Low intensity pulsed ultrasound (LIPU)","Therapeutic ultrasound","Blood-brain barrier (BBB)","Malignant brain tumor","Brain cancer","Carboplatin","Children","Adolescents","2026-04-30",{"date":120,"type":33},"2026-05-06",{"date":122,"type":33},"2023-02-06",{"date":124,"type":20},"2028-10-01",{"name":126,"class":40},"Assistance Publique - Hôpitaux de Paris",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100441586","phase-1-preoperative-radiosurgery-for-the-treatment-of-high-grade-glioma-neoglioma-trial-100441586","NCT05030298","Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial","Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \\[WHO\\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status\n* Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment\n* Planned neurosurgical resection of tumor\n* Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Negative pregnancy test done =\\\u003C 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide written informed consent\n* Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration\n* Willing to provide tissue and\u002For blood samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women who are unwilling to cease during therapy\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Prior history of cranial radiotherapy\n* Unwillingness to participate in study\n* Investigator discretion that enrollment on the study would pose undo harm or risk to the patient\n* Non-MRI compatible implanted medical device\n* Use of systemic anti-cancer therapy within the previous 3 months\n* Medical contraindication to craniotomy and tumor resection\n* Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor\n\n  * Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor\n* Primary spinal cord glioma or primary brainstem glioma\n* Residual tumor of excessive volume or eloquent location per investigator discretion\n* Patients who are unwilling or unable to comply with study procedures",{"count":136,"type":20},28,[23],"This phase I trial finds out the possible benefits and\u002For side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.",[28],"2026-04-20",{"date":142,"type":33},"2026-04-22",{"date":144,"type":33},"2023-05-23",{"date":146,"type":20},"2027-09-15",{"name":66,"class":40},2,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":41},"100635334","phase-1-dual-targeting-car-nk-cells-for-recurrentprogressive-glioblastoma-and-high-grade-glioma-100635334","NCT07551336","Dual-Targeting CAR-NK Cells for Recurrent\u002FProgressive Glioblastoma and High-Grade Glioma","A Phase 1, First-in-Human, Biomarker-Guided, Dose-Escalation and Expansion Study of Locoregional Dual-Targeting CAR-NK Cells Directed Against IL13Rα2, EGFR\u002FEGFRvIII, and\u002For B7-H3 (CD276) in Adults With Recurrent or Progressive Glioblastoma or High-Grade Glioma","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically confirmed glioblastoma (WHO grade 4) or diffuse high-grade glioma (WHO grade 3 or 4) that is recurrent or progressive after standard therapy.\n* Planned clinically indicated tumor resection or stereotactic biopsy (or availability of adequate archived tumor tissue) to support antigen testing and locoregional catheter placement.\n* Tumor demonstrates expression of at least two of the following antigens above protocol-defined thresholds: IL13Rα2, EGFR (wild-type) and\u002For EGFRvIII, B7-H3 (CD276).\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Adequate organ function (hematologic, renal, hepatic) as defined by protocol laboratory criteria.\n* Ability to undergo brain MRI with contrast (unless contraindicated and alternative imaging is permitted).\n* Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled bacterial, viral, or fungal infection).\n* Known HIV infection with uncontrolled viral load; active hepatitis B or hepatitis C with detectable viral load (unless permitted per protocol).\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Requirement for high-dose systemic corticosteroids (e.g., \\>4 mg\u002Fday dexamethasone equivalent) within 7 days prior to lymphodepletion\u002Finfusion (physiologic replacement permitted).\n* Prior gene-modified cellular therapy (e.g., prior CAR-T\u002FCAR-NK) within 6 months, or prior therapy targeting IL13Rα2, EGFR\u002FEGFRvIII, or B7-H3 where residual engineered cells could confound safety assessments.\n* Diffuse leptomeningeal disease as the only site of disease, or anatomy that precludes safe catheter placement (unless specifically allowed by protocol).\n* Uncontrolled seizures despite optimal medical therapy.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk with lymphodepletion or infusion procedures.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or could interfere with protocol adherence.","75 Years",{"count":158,"type":20},36,[23],"This is a draft, ClinicalTrials.gov-style example record for a first-in-human Phase 1 study evaluating locoregional administration of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in adults with recurrent or progressive glioblastoma (GBM) or other high-grade glioma (HGG). Participants will undergo tumor antigen profiling for IL13Rα2, EGFR\u002FEGFRvIII, and B7-H3 (CD276). Based on this assessment, each participant will receive the most suitable dual-target CAR construct to reduce antigen-escape risk.",[28,162,163,164,165],"High-Grade Gliomas","Glioblastoma","Recurrent High-Grade Gliomas","Recurrent Glioblastoma",[167,168,169,170,171,172,173,174,175,176],"CAR-NK","Dual targeting","Biomarker-guided","IL13Rα2","EGFR","EGFRvIII","B7-H3 (CD276)","Locoregional","Intracavitary","Ommaya reservoir","2026-04-18",{"date":179,"type":33},"2026-04-24",{"date":181,"type":33},"2026-03-02",{"date":183,"type":20},"2028-04-17",{"name":185,"class":186},"Beijing Biotech","INDUSTRY",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":198,"conditions":199,"keywords":204,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":41},"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":195,"type":20},30,[197],"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.",[200,201,202,28,203],"Glioma","Brain Tumor","Primary Brain Tumor","Malignant Primary Brain Tumor",[205,206,207,208],"Non-invasive glioma characterization","Molecular Imaging","Isocitrate Dehydrogenase (IDH) Mutations","MRI-Based Sequencing","2026-04-14",{"date":140,"type":33},{"date":212,"type":33},"2019-01-25",{"date":214,"type":20},"2027-01-31",{"name":216,"class":40},"University of Miami",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":153,"officialTitle":154,"acronym":221,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":160,"conditions":224,"keywords":227,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":41},"100629920","phase-1-dual-targeting-car-nk-cells-for-recurrentprogressive-glioblastoma-and-high-grade-glioma-100629920","NCT07480941","DUAL-CAR-NK-GB",{"count":158,"type":20},[23],[163,225,28,165,226],"High-grade Glioma","Recurrent High-grade Glioma",[167,228,170,171,172,229,230,231,232,176,233],"dual targeting","B7-H3","CD276","locoregional","intracavitary","biomarker-guided","2026-03-14",{"date":236,"type":33},"2026-03-18",{"date":238,"type":33},"2026-02-02",{"date":240,"type":20},"2028-03-17",{"name":185,"class":186},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":41},"100421746","serial-advanced-magnetic-resonance-imaging-scan-for-guidance-of-personalized-adaptive-radiotherapy-for-high-grade-glioma-100421746","NCT04771806","Serial Advanced Magnetic Resonance Imaging Scan for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma","Serial Advanced Magnetic Resonance Imaging (MRI) for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma","Inclusion Criteria:\n\n* All patients with histologic confirmation of high grade glioma\n* Patients must be age \\>= 18 years\n* Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol, and has been approved and amended by the MD Anderson Cancer Center (MDACC) Institutional Review Board (IRB)\n* Patients must have Karnofsky performance status (KPS) \\>= 60\n* Patients must be able to obtain an MRI scan with gadolinium contrast\n* Female patients of childbearing age must not be pregnant as determined with a serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breastfeeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy). Female patients who consent to participate in the study will need to use contraceptive methods for the duration of the study",{"count":250,"type":20},80,"OBSERVATIONAL","This study examines whether repeated magnetic resonance imaging (MRI)s scan helps identify changes in the tumor during radiation and chemotherapy treatment in patients with high grade glioma. Additional MRIs scan may help researchers to see changes in the status of the disease. Seeing these changes may result in changes to the treatment plan.",[28],"2026-03-03",{"date":256,"type":33},"2026-03-04",{"date":258,"type":33},"2019-04-01",{"date":260,"type":20},"2027-02-02",{"name":262,"class":40},"M.D. Anderson Cancer Center",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":41},"100627353","t2-star-magnetic-resonance-imaging-and-biomarker-blood-testing-to-predict-the-change-and-progress-of-malignant-gliomas-100627353","NCT07447531","T2 Star Magnetic Resonance Imaging and Biomarker Blood Testing to Predict the Change and Progress of Malignant Gliomas","Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression","Inclusion Criteria:\n\n* Age \\> 21 years\n* New pathologically confirmed diagnosis of WHO grade IV malignant glioma\n* KPS \\> 60\n* Ability to give informed consent for standard of care chemotherapy and radiation therapy on the MR Linac and to study procedures for the protocol\n\nExclusion Criteria:\n\n* History of previous malignancy other than non-melanoma skin cancer in the previous 5 years\n* History of iron metabolic disorder such as hemochromatosis\n* Inability to undergo MR studies due to size, claustrophobia, or metal implants or devices",{"count":271,"type":20},15,[197],"This clinical trial studies whether T2 star (T2\\*) magnetic resonance imaging (MRI) and biomarker blood testing can help predict how World Health Organization (WHO) grade IV gliomas (malignant gliomas) might change or progress over time.",[28],"2026-02-25",{"date":254,"type":33},{"date":278,"type":33},"2025-10-03",{"date":280,"type":20},"2028-10-06",{"name":282,"class":40},"John M. Buatti",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":41},"100489995","phase-1-carv3-team-e-t-cells-in-glioblastoma-100489995","NCT05660369","CARv3-TEAM-E T Cells in Glioblastoma","INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM","Inclusion Criteria:\n\n* Safety Run In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant\n\n  * Participants must have histologically confirmed recurrent GBM or molecular features of GBM with presence of EGFRvIII mutation detected at initial diagnosis. MGMT methylated, unmethylated, or unknown is allowed.\n  * Participants must be at first progression or recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.\n\nParticipants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent before proceeding with collection or treatment. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.\n\n* ARM 2: Newly Diagnosed GBM, EGFRvIII mutant (will only open once safety is confirmed in Arms 1 and 3)\n\n  * Participants must have histologically confirmed newly diagnosed GBM with presence of EGFRvIII mutation and their tumors must be MGMT unmethylated.\n  * Treatment planned with involved field radiation alone without concomitant or sequential temozolomide.\n* ARM 3: Recurrent GBM, EGFRvIII negative\n\n  * Participants must have histologically confirmed recurrent GBM with EGFR amplification but no EGFRvIII mutation based on initial diagnostic tissue.\n  * Participants must be at first recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.\n\nParticipants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.\n\n* ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:\n\n  * Must be at least 3 months from completion of radiation or evidence of progression is outside the high dose radiation field.\n* Safety Run-In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:\n\n  * Participants must have measurable disease, defined as at least one lesion ≥10 mm (≥1 cm) with MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n* ALL ARMS:\n\n  * Patients cannot have posterior fossa or intramedullary spine-only disease. Leptomeningeal disease is allowed anywhere in the neuroaxis. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n  * Resolution of AEs from any prior systemic anticancer therapy or radiotherapy to Grade 1 or baseline (except Grade 2 alopecia and Grade 2 sensory neuropathy)\n  * Medically able and willing to undergo placement of an Ommaya reservoir.\n  * Steroid dose anticipated to be ≤ 4 mg of dexamethasone a day or equivalent at time of first CAR-v3-TEAM-E infusion.\n  * Age ≥18 years\n  * Karnofsky ≥60%\n  * Must be able to undergo an MRI with contrast.\n  * Life expectancy of greater than 3 months.\n  * Participants must have adequate organ and marrow function as defined below:\n\n    * Absolute neutrophil count ≥1,000\u002FmcL\n    * Platelets ≥80,000\u002FmcL\n    * Total bilirubin ≤ institutional upper limit of normal (ULN); For patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.\n    * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n    * CrCl ≥ 60 mL\u002Fmin\n  * Participant has no prior history of malignancy, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative\n  * Left ventricular ejection fraction \\>50% as determined by TTE.\n  * The effects of CARv3-TEAM-E on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CARv3-TEAM-E administration.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Intraparenchymal posterior fossa disease\n* Intramedullary spinal disease as the only site of disease.\n* Prior EGFRvIII targeted therapies.\n* Prior bevacizumab treatment.\n* Treatment with an any prior gene-therapy or gene-modified cellular therapy.\n* Patients with a VP shunt or patients needing a shunt in the immediate future are excluded from participating\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CARv3-TEAM-E (ex. cetuximab).\n* Participants with uncontrolled intercurrent illness.\n* Human immunodeficiency virus (HIV)-infected participants are not eligible.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) infection are not eligible.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CARv3-TEAM-E , breastfeeding should be discontinued if the mother is treated with CARv3-TEAM-E.\n* For Arm 2, prior to CARv3-TEAM-E Infusion, the following criteria should be confirmed in addition to the relevant criteria above:\n\n  * Participants must have completed 75% of the planned 6 weeks of involved field radiation without temozolomide\n  * Tumor location and size criteria as in 3.1.7 above.\n  * Prior cancer directed therapy other than radiation is not allowed.",{"count":291,"type":20},21,[23],"The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma.\n\nThe name of the treatment intervention used in this research study is:\n\n-CARv3-TEAM-E T Cells (or Autologous T lymphocytes).",[163,28,165,295],"Recurrent Glioma",[163,28,165,295,297,298],"Immunotherapy","Gene-Transfer Therapy",{"date":300,"type":33},"2026-02-04",{"date":302,"type":33},"2023-03-22",{"date":304,"type":20},"2027-09-01",{"name":306,"class":40},"Marcela V. Maus, M.D.,Ph.D.",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":314,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":41},"100552255","mapping-of-electrical-properties-in-the-brain-100552255","NCT06470711","Mapping of Electrical Properties in the Brain","Mapping of Electrical Properties in the Brain.","Inclusion Criteria:\n\n* Aim 1: normal healthy volunteers\n* Aim 2, 3, 4: participants included in IRB 16-002424, including those that have undergone surgical biopsy\u002Fresection for suspected or known glioma\n\nExclusion Criteria:\n\n* Healthy volunteer unable to have an MRI",true,{"count":316,"type":20},120,"This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.",[28],"2026-01-30",{"date":321,"type":33},"2026-02-03",{"date":323,"type":33},"2024-09-13",{"date":325,"type":20},"2027-09-30",{"name":66,"class":40},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":41},"100494359","early-phase-1-intratumoral-extracellular-metabolic-impact-of-dfmo-and-amxt-1501-in-patients-with-diffuse-or-high-grade-glioma-100494359","NCT05717153","Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma","Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma\n* Planned subtotal resection or biopsy due to tumor location, size, or other clinical indication deemed appropriate by the surgeon\n* Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of cerebrospinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard post-operative stay to undergo longitudinal microdialysis\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL without transfusion within 7 days preceding the lab assessment (obtained =\\\u003C 14 days prior to registration)\n* Platelet \\>= 100 x 10\\^9\u002FL, without transfusion within 7 days preceding the lab assessment (obtained =\\\u003C 14 days prior to registration)\n* Hemoglobin \\>= 9 g\u002FdL, without transfusion support within 7 days preceding the lab assessment (obtained =\\\u003C 14 days prior to registration)\n* Activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) =\\\u003C 1.5 x upper limit of normal (ULN) (obtained =\\\u003C 14 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Total serum bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* The patient is clinically euthyroid \\[Thyroid Stimulating Hormone (TSH)\\]\n* Serum creatinine =\\\u003C 1.5 x ULN or creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with serum creatinine levels above 1.5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Negative serum or urine pregnancy test is required for female subjects of childbearing age \\\u003C 14 days prior to registration\n\nExclusion Criteria:\n\n* Inappropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings\n* Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped\n* Unable to swallow tablets or who are at risk for impaired absorption of oral medication. NOTE: This includes but not limited to, refractory vomiting, gastric resection\u002Fbypass, and duodenal\u002Fjejunal resection\n* Known hypersensitivity or allergy to DFMO or AMXT 1501\n* Contraindication to MRI or administration of gadolinium",{"count":335,"type":20},18,[337],"EARLY_PHASE1","This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. DFMO is an irreversible inhibitor of ornithine decarboxylase, the enzyme catalyzing polyamine synthesis. AMXT 1501 is a polyamine transport inhibitor which prevents uptake of polyamines from the extracellular environment. This trial is being done to analyze how DFMO and AMXT 1501 affect brain tumor metabolism based on the molecules in the tumor's fluid.",[340,28],"Diffuse Glioma","2025-10-31",{"date":343,"type":33},"2025-11-04",{"date":345,"type":33},"2023-10-01",{"date":146,"type":20},{"name":66,"class":40}]