[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"central-nervous-system-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:central-nervous-system-tumor":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,67,153,187,204,235,265,290,308,377],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":39,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100645242","phase-2-illuminate-a-clinical-study-evaluating-car-t-immune-cell-therapy-bcb-276-for-patients-with-diffuse-intrinsic-pontine-glioma-dipg-100645242",false,"NCT07680439","Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).","A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n* Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.\n* Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma\n* Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.\n* Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.\n* Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.\n* Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).\n* Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.\n* Participants of childbearing\u002Ffathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.\n* Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.\n* Participant must meet all other health and safety criteria defined in the study protocol.\n* Participant and\u002For authorized legal representative willing to provide consent\u002Fassent for study participation, including participation in the 15-year long term follow up period.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.\n* Evidence of metastatic disease.\n* Requirement of high or increasing doses of corticosteroids prior to participation.\n* Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.\n* Presence of an active malignancy other than DIPG.\n* Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.\n* Pregnant or breastfeeding.\n* Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.","ALL","1 Year","26 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG.\n\nTo participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study.\n\nBCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.",[27,28,29,30,31,32,33,34,35,36,37,38],"Diffuse Intrinsic Pontine Glioma","DIPG","Brain Tumor","CNS Tumor","Central Nervous System Tumor","Pediatric Cancer","Adult Cancer Patients","CNS Tumor, Childhood","CNS Tumor, Adult","Brainstem Glioma","Diffuse Midline Glioma","DMG",[40,41,42,43,44,45,46,47,48,49,50,51,52,53],"BCB-276","B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy","B7-H3","B7-H3 CAR T","B7-H3 CAR T Cells","Chimeric antigen receptor T cells","CAR T Cell","Immunotherapy","Cell Therapy","Pediatric","Children","Adolescent","Young Adult","Adult","NOT_YET_RECRUITING","2026-06-25",{"date":57,"type":58},"2026-07-02","ACTUAL",{"date":60,"type":21},"2026-07",{"date":62,"type":21},"2030-07",{"name":64,"class":65},"BrainChild Bio, Inc","INDUSTRY",6,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":79,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":132,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":78,"type":21},999999,"80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,31,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[83,84,133,134,135,136,137,138,139,140,120,141,130,131],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING",{"date":144,"type":58},"2026-06-29",{"date":146,"type":58},"2013-11-01",{"date":148,"type":21},"2099-12",{"name":150,"class":151},"University of Nebraska","OTHER",42,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":167,"conditions":168,"keywords":175,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100418695","phase-1-onc206-for-treatment-of-newly-diagnosed-recurrent-diffuse-midline-gliomas-and-other-recurrent-malignant-cns-tumors-100418695","NCT04732065","ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors","Open Label Phase 1 and Target Validation Study of ONC206 in Children and Young Adults With Newly Diagnosed or Recurrent Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors","PNOC023","Inclusion Criteria:\n\n* ARM A: Children and young adults with DMG, H3K27 altered (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) who completed at least one line of prior therapy. Prior treatment must have included focal radiation therapy and patients must be within 4-14 weeks from completion of radiation therapy to registration (patients must start treatment within 1 week from registration), have not started any other therapies post-radiation, and have no evidence of disease progression.\n* ARM A: Tumor tissue confirmation of DMG, H3K27 altered is mandatory and pathology must be consistent with a DMG, H3K27 altered.\n* ARM A: Participants must have recovered from all acute side effects of prior therapy.\n* ARM A: From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 4 weeks from antibodies and must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any biologic or small molecule agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur (these should be discussed with the study team)\n* ARM B: Newly diagnosed children and young adults (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) with a diagnosis of DMG, H3K27 altered are eligible, including spinal cord DMGs.\n* ARM B: Tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG, H3K27 altered.\n* ARM C: Children and young adults with DMGs (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) who have evidence of progression but have not been treated for this progression and are recommended to get re-irradiation.\n* ARM C: Patients must have undergone prior focal radiation therapy as part of their initial therapy and should be at least 6 months from prior radiation therapy. If timing is less than 6 months from prior focal radiation, these patients need to be discussed with the study chair(s).\n* ARM C: Tumor tissue confirmation is mandatory and pathology must be consistent with a DMG, H3K27 altered.\n* ARM C: Participants must have recovered from all acute side effects of prior therapy\n* ARM C: From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 4 weeks from antibodies and must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any biologic or small molecule agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur (these should be discussed with the study team)\n* ARM D: Children and young adults with recurrent primary malignant CNS tumors, excluding DMGs, (Dose escalation: 2-21 years of age; Dose expansion: 2 years of age and above) who have evidence of progression but have not been treated for this progression. Participants who received a surgical resection for that progression are eligible if surgery has no curative intent. These patients need to be discussed with the study team.\n* ARM D: Prior tumor tissue confirmation is mandatory and pathology from the primary tumor must be consistent with malignant CNS tumor (diagnosis of ependymoma is allowed).Tissue at the time of progression is not required.\n* ARM D: Participants must have recovered from all acute side effects of prior therapy\n* ARM D: From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 4 weeks from antibodies and must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any biologic or small molecule agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur (these should be discussed with the study team). Bevacizumab used for pseudoprogression does not require a wash out period.\n* TARGET VALIDATION: Newly diagnosed children and adults (2 years of age and above) with imaging consistent with a DMG, H3K27 altered are eligible.\n* TARGET VALIDATION: Children and young adults with recurrent primary malignant CNS tumors, including recurrent DMG, (2 years of age and above) who have evidence of progression but have not been treated for this progression.\n* TARGET VALIDATION: Participants must undergo tumor tissue collection as part of their standard of care\n* Participants who are receiving steroids must be on a stable or decreasing dose for at least 3 days prior to registration.\n* Peripheral absolute neutrophil count (ANC) \\>= neutrophil 1.0 g\u002Fl.\n* Platelet count \\>= 100 x 10\\^9\u002FL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Serum creatinine \\\u003C 1.5 Upper Limit normal (ULN) based on age and gender.\n* Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \\\u003C 3 x ULN or direct bilirubin \\\u003C 1.5 x ULN.\n* Alanine aminotransferase (ALT) \\\u003C= 3 x ULN.\n* Aspartate aminotransferase (AST) \\\u003C= 3 x ULN.\n* Patients with seizure disorder may be enrolled if seizure disorder is well controlled\n* The effects of ONC206 on the developing human fetus is unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception. Adequate methods include: hormonal or barrier method of birth control; or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation\n* Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants =\\\u003C 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* Participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required. Frozen tissue is also acceptable. Participants who previously enrolled on PNOC022 and provided adequate tissue, may not need to submit additional tissue - confirm with Study Chairs. Participants who do not meet this criterion may be discussed on a case-by-case basis with the Study Chairs.\n* A legal parent\u002Fguardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate\n* Patients must be enrolled on PNOC COMP if PNOC COMP is open to accrual at the enrolling institution\n\nExclusion Criteria:\n\n* Arm A \\& B: For tumors that do not have a pontine or spinal cord epicenter the following specific exclusion criteria apply: Thalamic DMG and cerebellar, H3K27 altered that has undergone standard radiation without concurrent therapy (other than temozolomide).\n* Arm C \\& D: Patients who participated in trials investigating ONC201 in the upfront setting will not be eligible. Prior ONC201 exposure as part of PNOC022 or expanded access programs will be allowed.\n* Participants who are currently receiving another investigational drug are not eligible.\n* Participants who are currently receiving other anti-cancer agents are not eligible.\n* Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair.\n* Participants with uncontrolled infection.\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy.\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC206.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or family.\n* Any participants with illnesses that may affect absorption of ONC206.\n* Any participants on strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9 and 2C19 at least 14 days prior and throughout the study.","2 Years","21 Years",{"count":164,"type":21},208,[166],"PHASE1","This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called \"stress response\" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.",[169,170,171,172,173,174,30,31],"Diffuse Midline Glioma (DMG)","Glioblastoma","Recurrent Ependymoma","Recurrent Malignant Central Nervous System Neoplasm","Spinal Cord Glioma","World Health Organization (WHO) Grade III Glioma",[176],"H3 K27M-Mutant","2026-06-08",{"date":179,"type":58},"2026-06-11",{"date":181,"type":58},"2021-08-23",{"date":183,"type":21},"2027-07-31",{"name":185,"class":151},"Sabine Mueller, MD, PhD",7,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":193,"phases":4,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":201,"locationsCount":203},"100478572","expanded-access-11c-methionine-pet-imaging-100478572","NCT05511714","Expanded Access [11C] Methionine PET Imaging","Inclusion Criteria:\n\n* All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.\n* No limit on age.\n* Patients of all genders and all ethnic groups under the care of a SJCRH physician.\n* Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.\n* Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board.\n\nExclusion Criteria:\n\n* More than six L-\\[11C\\]methionine PET scans within the previous 12 months.\n* Inability or willingness of patient, parent, or guardian to consent.","EXPANDED_ACCESS","The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment.\n\nPrimary Objective\n\nTo provide expanded access to L-\\[11C\\]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.",[31,196],"Head and Neck Neoplasms","AVAILABLE","2026-04-23",{"date":200,"type":58},"2026-04-24",{"name":202,"class":151},"St. Jude Children's Research Hospital",1,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":224,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":203},"100376708","phase-1-study-of-b7-h3-specific-car-t-cell-locoregional-immunotherapy-for-diffuse-intrinsic-pontine-gliomadiffuse-midline-glioma-and-recurrent-or-refractory-pediatric-central-nervous-system-tumors-100376708","NCT04185038","Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma\u002FDiffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors","Phase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma\u002FDiffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors","Inclusion Criteria:\n\n1. Age ≥ 1 and ≤ 26 years\n2. Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy\n3. Able to tolerate apheresis, or has apheresis product available for use in manufacturing\n4. CNS reservoir catheter, such as an Ommaya or Rickham catheter\n5. Life expectancy ≥ 8 weeks\n6. Lansky or Karnofsky score ≥ 60\n7. If patient does not have previously obtained apheresis product, patient must have discontinued, and recovered from acute toxic effects of, all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment:\n\n   1. ≥ 7 days post last chemotherapy\u002Fbiologic therapy administration\n   2. 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy\n   3. Must be at least 30 days from most recent cellular infusion\n   4. All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy is allowed.\n8. Adequate organ function\n9. Adequate laboratory values\n10. Patients of childbearing\u002Ffathering potential must agree to use highly effective contraception\n\nExclusion Criteria:\n\n1. Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention\n2. Presence of primary immunodeficiency\u002Fbone marrow failure syndrome\n3. Presence of clinical and\u002For radiographic evidence of impending herniation\n4. Presence of \\>Grade 3 dysphagia\n5. Presence of active malignancy other than the primary CNS tumor under study\n6. Presence of active severe infection\n7. Receiving any anti-cancer agents or chemotherapy\n8. Pregnant or breastfeeding\n9. Subject and\u002For authorized legal representative unwilling or unable to provide consent\u002Fassent for participation in the 15 year follow up period\n10. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol",{"count":212,"type":21},90,[166],"This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor resection cavity or ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors.\n\nA child or young adult meeting all eligibility criteria, including having a CNS catheter placed into the tumor resection cavity or into their ventricular system, and meeting none of the exclusion criteria, will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that targets B7H3-expressing tumor cells. Patients will be assigned to one of 3 treatment arms based on location or type of their tumor. Patients with supratentorial tumors will be assigned to Arm A, and will receive their treatment into the tumor cavity. Patients with either infratentorial or metastatic\u002Fleptomeningeal tumors will be assigned to Arm B, and will have their treatment delivered into the ventricular system. The first 3 patients enrolled onto the study must be at least 15 years of age and assigned to Arm A or Arm B. Patients with DIPG will be assigned to Arm C and have their treatment delivered into the ventricular system. The patient's newly engineered T cells will be administered via the indwelling catheter for two courses. In the first course patients in Arms A and B will receive a weekly dose of CAR T cells for three weeks, followed by a week off, an examination period, and then another course of weekly doses for three weeks. Patients in Arm C will receive a dose of CAR T cells every other week for 3 weeks, followed by a week off, an examination period, and then dosing every other week for 3 weeks. Following the two courses, patients in all Arms will undergo a series of studies including MRI to evaluate the effect of the CAR T cells and may have the opportunity to continue receiving additional courses of CAR T cells if the patient has not had adverse effects and if more of their T cells are available.\n\nThe hypothesis is that an adequate amount of B7H3-specific CAR T cells can be manufactured to complete two courses of treatment with 3 or 2 doses given on a weekly schedule followed by one week off in each course. The other hypothesis is that B7H3-specific CAR T cells can safely be administered through an indwelling CNS catheter or delivered directly into the brain via indwelling catheter to allow the T cells to directly interact with the tumor cells for each patient enrolled on the study. Secondary aims of the study will include evaluating CAR T cell distribution with the cerebrospinal fluid (CSF), the extent to which CAR T cells egress or traffic into the peripheral circulation or blood stream, and, if tissues samples from multiple timepoints are available, also evaluate disease response to B7-H3 CAR T cell locoregional therapy.",[31,27,37,216,217,218,219,220,221,222,223],"Ependymoma","Medulloblastoma, Childhood","Germ Cell Tumor","Atypical Teratoid\u002FRhabdoid Tumor","Primitive Neuroectodermal Tumor","Choroid Plexus Carcinoma","Pineoblastoma, Childhood","Glioma",[225],"CNS, CAR T cell, B7-H3, pediatric, young adult, brain tumor, DIPG, DMG","2026-04-07",{"date":228,"type":58},"2026-04-13",{"date":230,"type":58},"2019-12-11",{"date":232,"type":21},"2042-05",{"name":234,"class":151},"Seattle Children's Hospital",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":203},"100622058","a-clinical-prediction-model-for-surgical-site-infection-after-central-nervous-system-tumor-surgery-100622058","NCT07378683","A Clinical Prediction Model for Surgical Site Infection After Central Nervous System Tumor Surgery","A Prospective, Single-Center Clinical Validation Study: Machine Learning Model-Based Risk Stratification Intervention for Reducing Surgical Site Infection After Central Nervous System Tumor Surgery","Inclusion Criteria:\n\n1. Patients with a pathologically confirmed primary or metastatic central nervous system (brain or spinal) tumor.\n2. Scheduled for elective craniotomy or spinal tumor resection surgery.\n3. Age ≥ 18 years.\n4. Expected survival \\> 3 months, and able\u002Fwilling to comply with postoperative follow-up.\n5. Voluntary participation and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Presence of active systemic or local surgical site infection before surgery.\n2. Use of therapeutic antibiotics for any reason within 72 hours prior to surgery.\n3. Concurrent severe immunosuppressive conditions, or chronic use of high-dose immunosuppressants.\n4. Pregnancy or lactation.\n5. Known contraindications or severe allergy to the antibiotics planned for use in the study.\n6. Any other condition that, in the investigator's judgment, may affect study participation or outcome assessment.",{"count":243,"type":21},500,[245],"NA","1. Study Background For patients undergoing brain or spinal tumor surgery, postoperative surgical wound infection (known as \"surgical site infection,\" SSI) is a recognized risk. Once an infection occurs, it may complicate and prolong the recovery process. Currently, doctors primarily rely on clinical experience to judge which patients are at higher risk of infection. Our research team has previously developed an intelligent prediction model (a machine learning tool) that can very accurately identify which patients are at higher risk of postoperative infection. This study aims to validate whether implementing enhanced preventive measures for high-risk patients in advance, based on the model's predictions, can effectively reduce the occurrence of infection.\n2. Study Purpose The primary purpose of this study is to validate whether an individualized intervention strategy based on an intelligent prediction model can effectively reduce the incidence of surgical site infection in patients after central nervous system tumor surgery. Simultaneously, we will also evaluate the safety of this strategy, its impact on patient hospital stay length and medical costs, as well as its feasibility in practical clinical application.\n3. Study Design Type: This is a prospective, single-center clinical validation study. \"Prospective\" means the research plan is established first, followed by patient recruitment and data collection according to the plan; \"single-center\" indicates the study is conducted solely at the Chinese Academy of Medical Sciences Cancer Hospital.\n\n   Process: For all patients who consent to participate in this study, within 72 hours after surgery, the research system will automatically calculate their infection risk based on 8 key clinical indicators (such as blood test results, medical history, etc.).\n\n   High-Risk Group (model-predicted infection probability ≥50%): Will receive a set of enhanced, individualized infection prevention measures (e.g., adjusted antibiotic regimen, enhanced nutritional support, closer monitoring).\n\n   Low-Risk Group (model-predicted infection probability \\\u003C50%): Will receive the current standard, high-quality postoperative care.\n\n   Duration: The study is planned to run from February 2026 to October 2029. Each participating patient will be followed for 3 months (90 days) to observe whether infection occurs.\n\n   Sample Size: It is planned to recruit approximately 500 eligible patients.\n4. Primary Evaluation Indicators Primary Indicator: The incidence of surgical site infection within 90 days after surgery. The diagnosis of infection will be made by experts who are unaware of the patient's group assignment, strictly following international standards.\n\n   Secondary Indicators: Include the accuracy of the intelligent prediction model in practical use, patient hospital stay length, other infection-related complications, medical costs, and the adoption rate of the model's recommendations by physicians.\n5. Eligibility Criteria (Inclusion Criteria Summary)\n\n   You may be eligible to participate in this study if you meet the following conditions:\n\n   Diagnosed with a brain or spinal tumor and scheduled for elective surgery. Aged 18 years or older. Expected survival exceeds 3 months and able to cooperate with postoperative follow-up.\n\n   Voluntary participation and signing of a written informed consent form. (Note: This study has detailed exclusion criteria. Final confirmation of whether all criteria are met will be determined by your study doctor.)\n6. Patients' Rights and Safety Voluntary Participation: Participation in this study is entirely voluntary. You have the right to withdraw from the study at any time, which will not affect the quality of any normal medical services you are entitled to at our hospital or your relationship with it.\n\n   Informed Consent: Before the study begins, your study doctor will explain all study procedures, potential risks, and benefits in detail, and you will sign an \"Informed Consent Form.\" Privacy Protection: All your personally identifiable information will be kept strictly confidential. Codes will replace your name and other identifiable information in research analyses and reports.\n\n   Safety Assurance: This study has been reviewed and approved by the hospital's Ethics Committee. We have established an independent Data Safety Monitoring Board to monitor the study's safety throughout. Clinical trial liability insurance has been purchased for all participants to cover damages related to the trial.\n7. Contact Information\n\nIf you would like to learn more about this study, please contact us via:\n\nPrincipal Investigator: Dr. Yang Ming National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Research Unit: Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College",[248,31],"Surgical Site Infection (SSI)",[250,251,252,253,254,255],"surgical site infection","central nervous system tumor","machine learning","explainable artificial intelligence","SHAP","clinical decision support system","2026-01-22",{"date":258,"type":58},"2026-01-30",{"date":260,"type":58},"2025-06-01",{"date":262,"type":21},"2029-10-30",{"name":264,"class":151},"Ming Yang",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":203},"100520263","somatic-mosaicism-in-twins-discordant-for-childhood-cancer-100520263","NCT06054295","Somatic Mosaicism in Twins Discordant for Childhood Cancer","Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study","Inclusion Criteria:\n\n* Newly diagnosed patient with CNS tumor or have recurrent disease and enrolled on APEC14B1.\n* Patient must have same sex twin. Note: (history of) treatment on a COG therapeutic trial is not required.\n* Patients must be diagnosed at \\\u003C 19 years of age at the time of diagnosis.\n* A family is eligible to participate if the twin with the CNS tumor is deceased but has a blood sample banked through APEC14B1.\n* All patients and\u002For their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.\n* All institutional, FDA, and NCI requirements for human studies must be met.","18 Years",{"count":274,"type":21},50,"Somatic mosaicism in cancer associated genes is one potential explanation for discordance in childhood cancer that has not been fully explored to date. This pilot study will focus on twins with central nervous system (CNS) tumors who are identified through the Children's Oncology Group's Project: EveryChild (PEC) registry or volunteer.",[277,31,278,279],"Pediatric Central Nervous System Tumor","Discordant Twin","Somatic Mutation","2025-12-11",{"date":282,"type":58},"2025-12-16",{"date":284,"type":58},"2024-06-03",{"date":286,"type":21},"2027-06-30",{"name":288,"class":289},"Children's Oncology Group","NETWORK",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":74,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":203},"100427925","tissue-collection-for-drug-screening-and-bioanalysis-100427925","NCT04852354","Tissue Collection for Drug Screening and Bioanalysis","Inclusion Criteria for Tumor patients undergoing neurosurgery (cohort 1)\n\n1. Subject has presented with a suspected\u002Fconfirmed neoplastic CNS lesion and is undergoing a neurosurgical procedure in which CNS tissue and\u002For tumors associated with this tissue will be removed.\n2. There must be tissue available in excess of that required by neuropathology for diagnostic purposes.\n3. Subject of all ages included.\n4. Subjects who are pregnant can be included.\n5. Subjects who are neonates (0-4 weeks) can be included.\n\nInclusion Criteria for Non-tumor patients undergoing neurosurgery (cohort 2)\n\n1. Subject is between 4 weeks and 21 years of age and is undergoing a neurosurgical procedure at WCMC.\n2. Subject does not have a CNS tumor diagnosis.\n3. Subject should not be pregnant at the time of enrollment.\n\nInclusion Criteria for Autopsy tumor tissue donation (cohort 3)\n\n1. Subject of all ages included\n2. Subject has been diagnosed with a neoplastic CNS lesion at the time of passing.\n3. Subjects who are pregnant can be included.\n4. Subjects who are neonates (0-4 weeks) can be included.\n\nInclusion Criteria for parent of tumor patients\n\n1. Subject is the biological parent of a patient undergoing\u002F who underwent a neurosurgical procedure in which CNS tissue and\u002For tumors associated with this tissue will be\u002F was removed.\n2. Subject is the biological parent of patient enrolled in cohort 1.\n3. Subject is not pregnant at the time of enrollment.",{"count":243,"type":21},"The purpose of this study is to improve upon the knowledge currently available about central nervous system (CNS) tumors. We will study the different characteristics of these tumors using tissue samples collected during surgery and post-autopsy. The aim is to create tumor cell lines and models to test how they respond to different drugs. This research will help improve treatment options and identify new targets for therapy.",[31],"2025-12-09",{"date":301,"type":58},"2025-12-17",{"date":303,"type":58},"2020-07-22",{"date":305,"type":21},"2029-07-22",{"name":307,"class":151},"Weill Medical College of Cornell University",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":314,"targetDuration":316,"studyType":80,"phases":4,"briefSummary":317,"conditions":318,"keywords":352,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100320510","synergy-ai-artificial-intelligence-based-precision-oncology-clinical-trial-matching-and-registry-100320510","NCT03452774","SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry","Inclusion Criteria:\n\n* Pts with solid and hematological malignancies;\n* Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2, HER2\u002FNeu, Tumor mutational burden\u002Fload (TMB), ABL1, ACVR1B, AKT1, AKT2, AKT3, ALK, APC, AR, ATM, ATRX, AURKA, AURKB, BAP1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BTK, CCND1, CCND2, CCND3, CDK4, CDK6, CDKN1A\u002FB, CEBPA, CHEK1, CHEK2, CSF1R, CTNNB1, DAXX, DDR1\u002F2, DNMT3A, EGFR, ERBB2, ERBB3, ERBB4, ERCC4, ER, ESR1, FANCA, FAS, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GATA3, GATA6, GNAS, HDAC1, HGF, HRAS, IDH1, IDH2, IGF1R, JAK1, JAK2, JAK3, KDR (VEGFR2), KIT, KRAS, MAP2K2 (MEK2), MAP3K1, MCL1, MDM2, MDM4, MEN1, MET, MSH2, MSH3, MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), NF1, NF2, NOTCH1, NPM1, NRAS, NTRK1, NTRK2, NTRK3, PALB2, PARP1, PARP2, PARP3, PBRM1, PDCD1 (PD1), PDCD1LG2 (PD-L2), PDGFRA, PDGFRB, PIK3C, PMS2, POLD1, POLE, PRDM1, PTCH1, PTEN, RAF1, RB1, RET, RICTOR, ROS1, RPTOR, SDHA\u002FB\u002FC, SMAD, SMARC, SMO, STK11, TGFBR2, TP53, TSC1, TSC2, VEGFA, VHL, WT1, ZNF217, ZNF703, CEACAM, NRG1, among others.\n\nThese biomarkers should be determined by local laboratory, external vendor, or next generation sequencing platform\n\n* Decision to consider clinical trial pre-screening enrollment (CTE) by primary provider and\u002For patient\n\nExclusion Criteria:\n\n* ECOG PS \\> 2;\n* Abnormal organ function;\n* Hospice enrollment",{"count":315,"type":21},50000,"36 Months","International registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.",[319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,129,337,338,339,340,121,341,342,170,31,122,343,101,126,127,105,120,344,345,346,347,348,349,350,351],"Cancer, Metastatic","Cancer","Cancer of Pancreas","Cancer of Liver","Cancer of Stomach","Cancer Liver","Cancer of Rectum","Cancer of Kidney","Cancer of Esophagus","Cancer of Cervix","Cancer of Colon","Cancer of Larynx","Cancer, Lung","Cancer, Breast","Cancer, Advanced","Cancer Prostate","Cancer of Neck","Cancer of Skin","Carcinoma","Mismatch Repair Deficiency","BRCA Gene Rearrangement","Non Hodgkin Lymphoma","Non Small Cell Lung Cancer","Cholangiocarcinoma","Urothelial Carcinoma","COVID","Myelofibrosis","Myeloproliferative Neoplasm","Myeloproliferative Disorders","Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Myelodysplastic Syndromes",[353,354,355,356,357,252,358,359,360,361,362,363,364,365,366],"artificial intelligence","virtual tumor board","clinical trial","clinical trial matching","electronic medical record","cost of care","targeted therapy","immunotherapy","precision medicine","precision oncology","cancer","value based care","real world data","data analytics","2025-10-25",{"date":369,"type":58},"2025-10-28",{"date":371,"type":58},"2018-01-01",{"date":373,"type":21},"2040-06",{"name":375,"class":65},"Massive Bio, Inc.",68,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":203},"100514442","brain-slice-explants-to-predict-drug-response-in-brain-tumors-100514442","NCT05978557","Brain Slice Explants to Predict Drug Response in Brain Tumors","A Feasibility Study to Determine if a Novel Patient-derived Explant Platform Can Produce Drug Sensitivity Scores Within a Clinically Relevant Time Frame in Patients With CNS Tumors","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n1. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information or written assent and parental consent for pediatric subjects or surrogate consent provided by the subject's legally authorized guardians.\n2. A diagnosis of a tumor residing in the central nervous system with surgery plan to have surgical resection.\n3. The subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.\n\nExclusion Criteria:\n\n1. All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:\n\n   Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.\n2. Incarcerated individuals.",{"count":274,"type":21},"This biospecimen collection study will evaluate the feasibility of engrafting and testing resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response, in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and unfortunately there are no reliable precision oncology platforms that can identify the most effective therapy for each patient. Recent work has demonstrated the success of functional precision oncology platforms using patient-derived explant (PDE) at predicting drug response in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may prove effective as functional models for CNS tumors. The purpose of this study is to explore the feasibility of using a novel PDE platform to generate drug sensitivity scores from patients with central nervous system tumors in Pediatric and adult subjects having low- or high-grade CNS tumors resected. The secondary objective is to estimate the proportion of successfully scaled PDEs generated per given tumor size.",[31],[388,389],"patient-derived explant","tissue","2025-08-28",{"date":392,"type":58},"2025-08-29",{"date":394,"type":58},"2023-07-27",{"date":396,"type":21},"2028-03-01",{"name":398,"class":151},"UNC Lineberger Comprehensive Cancer Center"]