[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-of-cerebellum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-of-cerebellum":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,100],{"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":60,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100355699","phase-1-hsv-g207-in-children-with-recurrent-or-refractory-cerebellar-brain-tumors-100355699",false,"NCT03911388","HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 36 months and \\\u003C 22 years\n* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid\u002Frhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and\u002For chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.\n* A review of the MRI scan will be necessary to determine if the tumor location and size are such that the patient may be included in the study. The MRI scan must be reviewed and approved by the site neurosurgeon and\u002For study radiologist for enrollment. The following guidelines must be met: Lesion must be ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking. Tumor measurements should be confirmed on the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) form or the institutional MRI report\n* Patients must have fully recovered from acute treatment-related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to the date of G207 administration. All washout intervals below are measured relative to the date of G207 administration.\n* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea) to G207 administration.\n* Monoclonal antibodies: patient must have received the last dose ≥ 21 days prior to G207 administration\n* Investigational\u002FBiologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to G207 administration (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥\\>= 7 days).\n* Viral therapy: Patients must have received viral therapy ≥ 3 months prior to G207 administration and must have recovered from all acute toxicities potentially related to the agent\n* Radiation: Patients must have received their last fraction of craniospinal radiation (\\>24 Gy) or total body irradiation ≥ 3 months prior to G207 administration. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to G207 administration.\n* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to G207 administration.\n* Absolute neutrophil count \\> 1000\u002Fmm3\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.3 x control\n* Creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above institutional normal\n* Total bilirubin ≤ 1.5 mg\u002Fdl\n* Transaminases ≤ 3 times above the upper limits of the institutional norm\n* Patients \\\u003C 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60\n* Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from patient or legal guardian\n\nExclusion Criteria:\n\n* Acute infection, granulocytopenia or medical condition precluding surgery\n* Pregnant or lactating females\n* Diagnosis of encephalitis or central nervous system (CNS) infection ≤ 3 months prior\n* Receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis\n* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment\n* Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation or requires ongoing systemic corticosteroid therapy at a dose \\> 2 mg\u002Fday of dexamethasone (or equivalent) at the time of inoculation. For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency) is not considered immunosuppressive and does not constitute exclusion\n* Known human immunodeficiency virus (HIV) seropositivity\n* Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone)\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial\n* Concurrent anticancer or investigational drug","ALL","36 Months","22 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.\n\nFunding Source- FDA OOPD",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"Neoplasms, Brain","Glioblastoma Multiforme","Glioblastoma of Cerebellum","Neoplasms","Astrocytoma","Astrocytoma, Cerebellar","Neuroectodermal Tumors","Neuroectodermal Tumors, Primitive","Cerebellar PNET, Childhood","Cerebellar Neoplasms","Cerebellar Neoplasms, Primary","Cerebellar Neoplasm, Malignant","Cerebellar Neoplasm Malignant Primary","Neoplasm Metastases","Neoplasm Malignant","Neoplasms, Neuroepithelial","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Neoplasms, Glandular and Epithelial","Neoplasms, Nerve Tissue","Central Nervous System Neoplasms, Primary","Central Nervous System Neoplasms, Malignant","Nervous System Neoplasms","Neoplasms by Site","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medulloblastoma Recurrent","HSV","Virus","Pediatric Brain Tumor","Nervous System Cancer","Primitive Neuroectodermal Tumor (PNET) of Cerebellum",[61,62,28,63,64,65,66,67,68,69,70,71,72,73,74,75,30,76,77,78,79,80,81,82,83,56,55,84,85,86],"Brain Tumor, Recurrent","Glioma","Gliosarcoma","Medulloblastoma","Anaplastic Astrocytoma","Oligodendroglioma","Rhabdoid Tumor","Ependymoma","Germ Cell Tumor","Choroid Plexus Carcinoma","Cerebral Primitive Neuroectodermal Tumor","Giant Cell Glioblastoma","Atypical teratoid\u002Frhabdoid tumor","Secondary Malignant Cerebellar Tumor","Embryonal Tumor","Oncolytic Virus Therapy","Virotherapy, Oncolytic","Immunotherapy","Central Nervous System Agents","Antineoplastic Agents","Pediatric","Pediatrics","Oncolytic","Herpes Virus","G207","Oncolytic Herpes Virus","RECRUITING","2026-07-28",{"date":90,"type":91},"2026-07-29","ACTUAL",{"date":93,"type":91},"2019-09-12",{"date":95,"type":21},"2027-09-01",{"name":97,"class":98},"M.D. Anderson Cancer Center","OTHER",3,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100606851","phase-1-dll3-car-t-therapy-targeting-brain-tumors-100606851","NCT07180927","DLL3 CAR-T Therapy Targeting Brain Tumors","4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors","Inclusion Criteria:\n\n1. abilities to understand and the willingness to provide written informed consent;\n2. patients are ≥ 2 and ≤ 70 years old;\n3. recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg\u002Fday at the time of leukopheresis;\n4. Karnofsky performance score (KPS) ≥ 60;\n5. life expectancy \\>3 months;\n6. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500\u002Fmm\\^3; hemoglobin \\> 10 g\u002FdL; platelets \\> 100000 \u002Fmm\\^3; Bilirubin \\\u003C 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 2.5×ULN; creatinine \\\u003C 1.5×ULN;\n7. peripheral blood absolute lymphocyte count must be above 0.8×10\\^9\u002FL;\n8. satisfactory heart functions;\n9. patients must be willing to follow the instructions of doctors;\n10. women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.\n\nExclusion Criteria:\n\n1. a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;\n2. HIV positive;\n3. tuberculosis infection not under control;\n4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;\n5. history of allergic disease, or allergy to immune cells or study product excipients;\n6. patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","2 Years","70 Years",{"count":110,"type":21},30,[24,112],"PHASE2","The purpose of this study is to assess the feasibility, safety and efficacy of Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.",[29],[116,117,118],"CAR-T","Glioblastoma","DLL3","2025-09-12",{"date":121,"type":91},"2025-09-18",{"date":123,"type":91},"2025-09-10",{"date":125,"type":21},"2029-09-30",{"name":127,"class":98},"Shenzhen Geno-Immune Medical Institute",1]