[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"embryonal-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:embryonal-tumor":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,53,92,132,176,197,221],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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",false,"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","ALL","5 Years","17 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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.",[28,29,30],"Malignant Brain Tumor","Malignant Glioma","Embryonal Tumor",[32,33,34,35,36,37,38,39],"Low intensity pulsed ultrasound (LIPU)","Therapeutic ultrasound","Blood-brain barrier (BBB)","Malignant brain tumor","Brain cancer","Carboplatin","Children","Adolescents","RECRUITING","2026-04-30",{"date":43,"type":44},"2026-05-06","ACTUAL",{"date":46,"type":44},"2023-02-06",{"date":48,"type":22},"2028-10-01",{"name":50,"class":51},"Assistance Publique - Hôpitaux de Paris","OTHER",3,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100370165","phase-1-c7r-gd2car-t-cells-for-patients-with-gd2-expressing-brain-tumors-gail-b-100370165","NCT04099797","C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)","Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With GD2-expressing Brain Tumors (GAIL-B)","Procurement Inclusion Criteria:\n\nCohort 1:\n\n1. Histologically confirmed, GD2-expressing newly diagnosed DMG\u002FHGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.\n\n   OR\n\n   Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG\u002FHGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.\n\n   OR\n\n   Recurrent, refractory, or progressive high-grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma \"CNS embryonal tumors, AT\u002FRT, ependymal tumors, diffuse gliomas or glioneuronal tumors.\n\n   Cohort 2:\n\n   Recurrent, refractory, or progressive pontine HGG with confirmed GD2-expression or H3K27-altered DMG\n2. Tumors less than 5 cm in maximum dimension at enrollment\n\n   1. Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study\n   2. Tumors with \\>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared with pre-irradiation MRI.\n   3. Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked\n3. Measurable disease on at least 2 dimensions on MRI\n4. Age 12 months to 25 years\n5. Functional score (Karnofsky\u002FLansky) ≥ 50 expected at infusion (≥60 for cohort 2)\n\nProcurement Exclusion Criteria:\n\n1. Patients who are pregnant or breast feeding\n2. Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.\n\nTreatment Inclusion Criteria\n\nCohort 1:\n\n1. Histologically confirmed, GD2-expressing newly diagnosed DMG\u002FHGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.\n\n   OR\n\n   Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG\u002FHGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.\n\n   OR\n\n   Recurrent, refractory, or progressive high -grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma, CNS embryonal tumors, AT\u002FRT, ependymal tumors, diffuse gliomas, or glioneuronal tumors.\n\n   Cohort 2:\n\n   Recurrent, refractory, or progressive pontine H3K27-altered for DMG or HGG with confirmed GD2-expression.\n2. Tumors less than 5 cm in maximum dimension at enrollment\n\n   1. Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study\n   2. Tumors with \\>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared pre-irradiation MRI\n   3. Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked\n3. Measurable disease on at least 2 dimensions on MRI\n4. Central line (PICC or other) and Ommaya reservoir or VP shunt in place or planned to be placed. Central line\u002FPICC may be omitted for cycles that do not include lymphodepletion\n5. Age 12 months to 25 years\n6. Functional score (Karnofsky\u002FLansky) ≥ 50 (≥60 for cohort 2)\n7. Patients must have completed standard of care radiation therapy at least 4 weeks prior to administration of investigational agent. If bevacizumab was administered for management of radiation necrosis, therapy must be completed at least 4 weeks prior to administration of investigational agent.\n8. Stable neurologic exam for 7 days prior to enrollment\n9. Stable or decreasing dose of steroids (max. allowable dose of dexamethasone is 0.1 mg\u002Fkg\u002Fday over the past 7 days prior to infusion of investigational therapy)\n10. Organ function:\n\n    1. ANC \\> 1000 cells\u002Ful\n    2. Platelet count \\> 100,000 cells\u002Ful\n    3. Total bilirubin \\\u003C 1.5x ULN\n    4. ALT and AST \\\u003C 5x ULN\n    5. Serum creatinine or kidney within 2x ULN for age\n\nTreatment Exclusion Criteria\n\n1. Patients who received any other forms of immunotherapy ≤ 42 days before administration of investigational agent\n2. Patients who received colony-stimulating factors within 14 days prior to administration of lymphodepletion\n3. Patients receiving any concurrent anti-cancer therapy (treatment must occur at least three half-lives following prior anti-cancer therapy)\n4. Patients who are pregnant or breast feeding\n5. Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.","12 Months","25 Years",{"count":63,"type":22},56,[25],"In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare high-grade glioma that expresses GD2. Cohort 2 is for patients with a type of cancer called progressive diffuse intrinsic pontine glioma that expresses GD2.\n\nBecause there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that help the body fight infection.\n\nThis research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat cancer patients. They have shown promise but have not been strong enough to cure most patients.\n\nResearchers have found from previous research that they can put a new antibody gene into T cells that will make them recognize cancer cells and kill them. GD2 is a protein found on several different cancers. Researchers testing brain cancer cells found that many of these cancers also have GD2 on their surface.\n\nIn a study for neuroblastoma in children, a gene called a chimeric antigen receptor (CAR) was made from an antibody that recognizes GD2. This gene was put into the patients own T cells and given back to 11 patients. The cells did grow for a while but started to disappear from the blood after 2 weeks. The researchers think that if T cells are able to last longer they may have a better chance of killing tumor cells.\n\nIn this study, a new gene will be added to the GD2 T cells that can potentially cause the cells to live longer. T cells need substances called cytokines to survive. The gene C7R has been added that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.\n\nIn other studies using T cells researchers found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and it will allow the T cells to expand and stay longer in the body and potentially kill cancer cells more effectively.\n\nAfter treating 11 patients, the largest safe dose of GD2-CAR T cells given in the vein (IV) was determined. We are now combining an IV infusion with an infusion directly into the brain through the Ommaya reservoir or programmable VP shunt. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way.\n\nPatients will now be assigned to Cohort 1 and 2 based on their tumor type.\n\nThe GD2.C7R T cells are an investigational product not approved by the FDA.\n\nThe purpose of this study is to combine infusions into the vein in the first treatment cycle with infusions directly into the cerebrospinal fluid (CSF) in the brain (intracerebroventricularly) through the ommaya reservoir or programmable VP shunt for infusions cycles 2-24. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way, and additionally to evaluate how long they can be detected in the blood and CSF and what affect they have on brain cancer.",[67,68,30,69],"Diffuse Intrinsic Pontine Glioma","High Grade Glioma","Ependymal Tumor",[71,72,73,74,75,76,77,78,79,80,81],"Gene Therapy","CAR T-cells","chimeric antigen receptor","Brain Cancer","Immunotherapy","Glioma","Brain tumor","DIPG","ETMRs","Medulloepithelioma","Atypical teratoid\u002Frhabdoid tumors","2026-04-23",{"date":84,"type":44},"2026-04-27",{"date":86,"type":44},"2020-02-03",{"date":88,"type":22},"2041-02",{"name":90,"class":51},"Baylor College of Medicine",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":105,"conditions":106,"keywords":118,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100460636","phase-1-lutathera-for-treatment-of-recurrent-or-progressive-high-grade-cns-tumors-100460636","NCT05278208","Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors","Phase I\u002FII Study of Lutathera in Patients With Recurrent and\u002For Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET","All participants must meet the following inclusion and exclusion criteria. No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical evaluations to establish eligibility (except for \\[68Ga\\]Ga-DOTATATE PET) must be done within 7 days prior to enrollment.\n\n1. Screening Criteria\n\n   1.1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (any histologic grade) that is recurrent, progressive, or refractory. Note that patients with DIPG (based on radiographic\u002Fclinical diagnosis) who have undergone biopsy will be eligible with histologic diagnosis of grade II-IV infiltrating glioma. All tumors must have histologic verification either at the time of diagnosis or recurrence, except for patients meningioma who have not previously undergone biopsy or resection.\n\n   Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n\n   1.2 Prior Therapy Patients must have recurred\u002Fprogressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.\n\n   1.3 Screening Consent Participant\u002Flegal guardian is willing to sign a screening consent for \\[68Ga\\]Ga-DOTATATE PET imaging. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n2. Eligibility Criteria\n\n   * Phase I Age Patient must be ≥ 4 and \\\u003C12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.\n   * Phase II Age Patient must be 12 to \\\u003C\u002F=39 years at the time of enrollment.\n3. Inclusion Criteria\n\n   3.1 Uptake on \\[68Ga\\]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET\u002FCT in at least one tumor lesion (corresponding to known disease) equivalent to a Krenning score ≥2 (confirmed by central radiology review).\n\n   3.2 Prior Therapy Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy, or any other treatment modality prior to entering this study.\n\n   3.3 Chemotherapy Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.\n\n   3.4 Investigational\u002FBiologic Agent\n\n   ●Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.\n\n   For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n\n   ●Monoclonal Antibodies and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment.\n\n   3.5 Radiation\n\n   Patients must have had their last fraction of:\n   * Craniospinal irradiation or total body irradiation or radiation to \\> 50% of pelvis \\> 3 months prior to enrollment.\n   * Focal irradiation \\> 4 weeks prior to enrollment\n\n   3.6 Stem Cell Transplant\n\n   Patient must be:\n   * ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease\n   * ≥ 3 months since autologous stem cell transplant prior to enrollment\n\n   3.7 Growth Factors Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g. filgrastim, sargramostim or erythropoietin). Two weeks must have elapsed if patients received long-acting formulations.\n\n   3.8 Somatostatin analogs Patients must be off long-acting somatostatin analogs for at least 4 weeks and off short-acting somastatin analogs (i.e., octreotide) for at least 24 hours.\n\n   3.9 Neurologic Status\n   * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.\n   * Patients with seizure disorders may be enrolled if seizures are well controlled.\n\n   3.10 Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within two weeks of enrollment must be ≥ 50. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\n   3.11 Organ Function\n\n   Patients must have adequate organ and marrow function, both for eligibility for enrollment, and to begin each subsequent cycle of Lutathera, as defined below:\n   * Adequate Bone Marrow Function as defined as:\n\n     * Absolute neutrophil count ≥ 1.0 x 109 cells\u002F L\n     * Platelets ≥100 x 109 cells\u002F L (unsupported, defined as no platelet transfusion within 7 days)\n     * Hemoglobin ≥8 g\u002Fdl (may receive transfusions)\n   * Adequate Renal Function as defined as:\n\n     * Creatinine clearance or radioisotope GFR \\>70mL\u002Fmin\u002F1.73m2 OR\n     * A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows:\n\n       1 to \\\u003C 2 years: maximum serum creatinine 0.6 mg\u002FdL for males and females. 2 to \\\u003C 6 years: maximum serum creatinine 0.8 mg\u002FdL for males and females. 6 to \\\u003C 10 years: maximum serum creatinine 1.0 mg\u002FdL for males and females. 10 to \\\u003C 13 years: maximum serum creatinine 1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years: maximum serum creatinine 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n       ≥ 16 years: maximum serum creatinine 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n   * Adequate Liver Function as defined as:\n\n     * Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age\n     * AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional ULN\n     * Serum albumin ≥ 2g\u002FdL\n     * Coagulation parameters: INR \\\u003C1.5 times ULN and aPTT \\\u003C1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters\n   * Adequate Cardiac Function as defined as:\n\n     * Ejection fraction of ≥ 55% by echocardiogram\n     * Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)\n\n   3.12 Corticosteroids Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment, with a maximum dexamethasone dose of 2.5mg\u002Fm2\u002Fday.\n\n   3.13 Pregnancy Status Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   3.14 Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for at least 7 months after drug cessation in females of childbearing potential and for at least 4 months after drug cessation in males of child fathering potential.\n\n   3.15 Informed Consent The patient or parent\u002Fguardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines.\n4. Exclusion Criteria\n\n   4.1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible.\n\n   4.2 Presence of bulky disease Patients with bulky disease on imaging as described below are ineligible. Treating physicians are encouraged to request a rapid central imaging review to confirm fulfillment of these criteria if there are questions or concerns.\n\n   Bulky disease is defined as:\n   * Tumor with evidence of clinically significant uncal herniation or midline shift.\n   * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR.\n   * Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine.\n\n   Note that patients with metastatic or multi-focal disease (with exception of bone marrow) are eligible as long as no sites of disease meet above criteria for bulky disease.\n\n   4.3 Breast-feeding Nursing mothers are excluded from this study. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Lutathera.\n\n   4.4 Concurrent Illness\n   * Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.\n   * Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n   * Patients with type I diabetes.\n\n   4.5 Concomitant Medications\n   * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n   * Prior or current treatment with 177Lu-DOTATATE\u002FTOC or 90Y-DOTATATE\u002FTOC.\n\n   4.6 Prisoners will be excluded from this study.\n\n   4.7 Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits, obtain follow-up studies required to assess toxicity to therapy, or adhere to drug administration plan, other study procedures, and study restrictions.\n5. Inclusion of Women and Minorities Both males and females of all races and ethnic groups are eligible for this study.","4 Years","39 Years",{"count":102,"type":22},65,[25,104],"PHASE2","This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \\\u003C12 years (Phase I) or 12 to \\\u003C\u002F=39 years (Phase II) to test its safety and efficacy, respectively.\n\nFunding Source - FDA OOPD (grant number FD-R-0532-01)",[68,107,30,108,109,110,111,112,113,114,115,116,117],"Meningioma","Medulloblastoma","Anaplastic Ependymoma","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Malignant Glioma","Recurrent Medulloblastoma","Recurrent Primary Central Nervous System Neoplasm","Refractory Diffuse Intrinsic Pontine Glioma","Refractory Malignant Glioma","Refractory Medulloblastoma","Refractory Primary Central Nervous System Neoplasm",[119,120,121],"Somatostatin Receptor","DOTATATE","Lutathera","2026-04-08",{"date":124,"type":44},"2026-04-13",{"date":126,"type":44},"2022-11-21",{"date":128,"type":22},"2033-11",{"name":130,"class":51},"Nationwide Children's Hospital",4,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":139,"maxAge":4,"enrollmentInfo":140,"targetDuration":142,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":157,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":175},"100459206","observational-study-for-assessing-treatment-and-outcome-of-patients-with-primary-brain-tumours-using-cimpact-now-and-2021-who-classification-100459206","NCT05259605","Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification","Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification","* Age ≥ legal age of consent\n* Newly diagnosed or recurrent primary brain tumours within one of the 17 cohorts of interest\n* Archival tumour tissue from primary tumour available at the site. Representative tissue from first surgery is preferred, but tissue from surgery for recurrence is allowed. Exception: only tissue from first surgery is allowed for Cohort 16.\n* Available MRI\u002FCT scans from primary brain tumour at initial diagnosis\n* Patient's consent\n\nDeceased patient:\n\nThe clinical data and\u002For biological material and\u002For CT\u002FMRI\u002FPET images can be accessed and used if at least one of the following three conditions is met:\n\n* The patient agreed beforehand in his\u002Fher lifetime to a further use of his\u002Fher data and\u002For biological material and\u002For CT\u002FMRI\u002FPET images, or,\n* There is consent of a relative to use data and\u002For biological material and\u002For CT\u002FMRI\u002FPET images of the deceased patient, or,\n* There is a reference to a corresponding legal declaration covering the exemption in case of the impossibility or disproportion of getting access to an informed consent (e.g., causing strain on relatives of deceased patients).\n\nAdditionally, in all cases the following three points need to be fulfilled:\n\n* No documentation of previous objection of the patient to the (re-)use of their data, biological material, CT\u002FMR\u002FPET images for research purposes\n* A notification to an ethics committee for the re-use of these data, biological material and CT\u002FMRI\u002FPET images\n* Any other national requirements are fulfilled, if applicable","18 Years",{"count":141,"type":22},1650,"10 Years","OBSERVATIONAL","Every new classification depends on its prognostic power and on the type of treatment given. With the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments.\n\nThe goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.",[76,146,147,148,149,150,151,152,30,153,154,155,156],"Glioneuronal Tumor","Choroid Plexus Tumor","Pineal Tumors","Germ Cell Tumor","Tumor of the Sellar Region","Diffuse Midline Glioma, H3 K27M-Mutant","Ependymoma","Pineal Tumor","Hemangiopericytoma","Hemangioblastoma","Melanocytic Tumor of CNS",[158,159,160,161,162,163,164],"Rare primary brain tumor","2021 WHO Classification","molecular diagnosis","Gliomas","Choroid plexus tumors","Embryonal tumors","Pineal tumors","2025-12-11",{"date":167,"type":44},"2025-12-17",{"date":169,"type":44},"2023-03-21",{"date":171,"type":22},"2038-07-29",{"name":173,"class":174},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",42,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":182,"maxAge":61,"enrollmentInfo":183,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100493963","rare-embryonal-tumors-of-the-central-nervous-system-international-registry-100493963","NCT05711992","Rare Embryonal Tumors of the Central Nervous System: International Registry","Inclusion Criteria:\n\n* Patients diagnosed with rare embryonal tumors of CNS since 01.01.2010:\n\n  * ETMR (including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma (EBL) and medulloepithelioma (MEPL) which were previously classified as CNS-PNETs)\n  * FOXR2-activated CNS neuroblastoma\n  * cribriform neuroepithelial tumor\n  * CNS tumor with BCOR internal tandem duplication\n  * all patients diagnosed with neuroblastoma and ganglioneuroblastoma with no molecular genetic tests available\n* Patients ≤ 25 years of age\n* Signed informed consent form for prospective patients ≥ 18 years of age\n* Signed parental permission and child assent forms for prospective patients \\\u003C 18 years of age\n\nExclusion Criteria:\n\n• CNS metastases of extracranial embryonal tumors","1 Day",{"count":184,"type":22},300,"Central nervous system (CNS) tumors are the most common solid malignancies among children. Although some types of CNS tumors like medulloblastomas and low-grade gliomas are widespread and well-studied, there is a huge number of rare diseases that need further research. This international registry aims to establish a large multicenter database of pediatric and young adult patients with rare embryonal tumors of the central nervous system and describe the clinical presentations, diagnostics, treatment regimens, and outcomes. Embryonal tumors with multilayered rosettes (ETMR), FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, and CNS tumor with BCOR internal tandem duplication are extremely rare embryonal tumors some of which were first described in the last edition of the World Health Organization (WHO) Classification of Tumors of the Central Nervous System. Objectives of the registry are 1) to evaluate prognostic factors, 2) to identify diagnostic and treatment gaps, 3) to investigate the characteristics and outcome of the disease with different treatment regimens, and 4) to generate data-based prospective diagnostic and treatment recommendations.",[30],"2025-05-07",{"date":189,"type":44},"2025-05-08",{"date":191,"type":44},"2023-02-01",{"date":193,"type":22},"2033-02",{"name":195,"class":51},"Immune Oncology Research Institute",11,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":205,"maxAge":100,"enrollmentInfo":206,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100540942","integrated-analysis-of-therapy-response-and-resistence-in-embryonal-tumors-and-gliomas-100540942","NCT06323408","Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas","Prospective Collection of Clinical and Imaging Data, Radiotherapy Planning and Biomaterials for Integrated Analysis of Therapy Response and Resistance and Detection of Molecular Targets in Adolescents and Young Adults With CNS Tumors","BZKF-AYA","Inclusion Criteria:\n\n1. first diagnosis of high-risk CNS tumors including glioma IDHmutated, medulloblastoma, ependymoma and other intra-axial primary brain tumors\n2. adolescents and young adults (AYA; 15 to 39 years)\n3. Karnofsky status of 60 or higher\n4. resection, extended biopsy or stereotactic biopsy with sufficient tissue volume\n5. multimodal therapy planned at the discretion of the treating specialist\n6. expected survival time of at least 6 months\n7. informed consent from the patient or the patient's legal guardian prior to the first study procedure\n8. complete material collection expected.\n\nExclusion Criteria:\n\n1. synchronous independent tumor disease other than basal cell carcinoma and carcinoma in situ\n2. participation in interventional clinical trial except in standard arms of interventional clinical trials.","15 Years",{"count":207,"type":22},72,"The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape.",[210,30,108,152],"Glioma, Malignant","NOT_YET_RECRUITING","2025-03-24",{"date":214,"type":44},"2025-03-25",{"date":216,"type":22},"2025-05",{"date":218,"type":22},"2026-03",{"name":220,"class":51},"University Hospital Regensburg",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":91},"100462233","phase-1-gd2-car-t-cells-for-pediatric-brain-tumours-100462233","NCT05298995","GD2-CAR T Cells for Pediatric Brain Tumours","Phase I Study of Anti-GD2 Chimeric Antigen Receptor-Expressing T Cells in Pediatric and Young Adult Patients Affected by Relapsed\u002FRefractory Central Nervous System Tumors","Inclusion Criteria:\n\n1. Imaging assessments performed within 14 days of start of treatment\n2. Age: 6months-30years\n3. Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment\n4. Karnofsky\u002FLansky≥60\n5. Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence of chronic complications (i.e. treatment-associated thrombocytopenia), patient must be clinically stable, according to the opinion of the treating physicians, and meet all other eligibility criteria\n6. Positioning of an implantable intraventricular access device (CodmanHolterRickham reservoir, Integra LifeSciences, NJ, U.S.A) and a microdialysis probe (71 high cutoff microdialysis bolt catheter, M Dialysis AB, Stockholm Sweden)\n7. Written and signed informed consent from patients, parents or legal guardians. For subjects \\\u003C 18 year-old their legal guardian must give informed consent. In addition, pediatric subjects will be included in age-appropriate discussion and written informed assent will be obtained for those greater than or equal to 7 years of age, when appropriate\n8. Patients of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen\n9. Females of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Severe,uncontrolledactiveinfections\n3. HIV or active HCV and\u002For HBV infection\n4. Rapidly progressive disease with life expectancy \\\u003C 6 weeks\n5. Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts\n6. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN based on age and laboratory specific normal ranges\n7. Renal function: serum creatinine \\> 3x ULN for age\n8. Blood oxygen saturation \\\u003C 90%\n9. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO\n10. Marrow function: absolute neutrophils count (ANC) lower than 500\u002Fmm3 and\u002For platelets lower than 20.000 (not reached by transfusion)\n11. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable risk to the subject. 12.Concurrent or recent prior therapies, before infusion:\n\n    1. If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon- absorbable steroids is not exclusionary. Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\n    2. Systemic chemotherapy in the 3 weeks preceding infusion\n    3. Immunosuppressive agents less than or equal to 30 days\n    4. Radiation therapy must have been completed at least 6 weeks prior to enrollment\n    5. Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy\n\n13.Patient-derived GD2-CART01 production failure: vitality \\\u003C80%, CD3+ cells \\\u003C80%, CD3+ CAR+ cells \\\u003C20%, CD3+ CAR+ antitumor activity \\\u003C60% in functional co-culture assay at an Effector: Target ratio 1:1, viable CAR+ cells upon AP1903 exposition \\>20%, RCR positivity, Vector Copy Number \\>10, non-sterility, endotoxin contamination (\\> 1 EU\u002Fml)","6 Months","30 Years",{"count":231,"type":22},54,[25],"The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed\u002Frefractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.",[235,236,30,68,237,67,238],"Brain Tumor, Pediatric","Medulloblastoma, Childhood","Diffuse Midline Glioma","Brain Tumor Adult",[240,241,242,237,67,243,244,75,245,246],"Brain tumors","high grade glioma","medulloblastoma","CAR T cell","GD2-antigen","Pediatric Central Nervous System tumours","Central nervous system tumour young adults","2025-02-03",{"date":249,"type":44},"2025-02-05",{"date":251,"type":44},"2023-11-09",{"date":253,"type":22},"2038-11",{"name":255,"class":51},"Bambino Gesù Hospital and Research Institute"]