[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-gliomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-gliomas":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,82,119,140,174,235,260,295,323,358,384,406,435,461],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609136","early-phase-1-window-trial-of-fluorescently-labeled-nivolumab-irdye800-nivo800-in-high-grade-glioma-hgg-100609136",false,"NCT07210632","Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Patient must have imaging of highly suspicious high grade glioma (HGG)\n4. Patients for whom surgical craniotomy is planned as standard of care (SOC)\n5. Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) AST 9-80 (IU\u002FL) ALT 7-110 (IU\u002FL) BUN 6-50 (mg\u002FdL) Creatinine 0.5-3.0 (mg\u002FdL)\n\nExclusion Criteria:\n\n1. Patients not eligible for SOC surgical resection\n2. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n   Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n\n   Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n   Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n   Rash must cover \\\u003C 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\n   History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n6. Prior allogeneic stem cell or solid organ transplantation\n7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n8. Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n   Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n\n   Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n\n   Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n\n   Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n\n   Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment.\n10. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":18,"type":19},38,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.",[25,26,27,28,29,30,31],"Brain Cancer","HGG","Glioma","High Grade Glioma","High Grade Gliomas","High Grade Glioma (III or IV)","High Grade Glioma (HGG) of the Brain With BRAF Aberration",[33,34],"hgg","high grade glioma","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2026-03-27",{"date":43,"type":19},"2031-03-30",{"name":45,"class":46},"Eben Rosenthal","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100644629","brain-radiotherapy-imaging-for-high-grade-glioma-using-hypoxia-targeting-through-oxygen-enhanced-response-100644629","NCT07670455","Brain Radiotherapy Imaging for High-grade Glioma Using Hypoxia Targeting Through Oxygen-Enhanced Response","BRIGHTER","Inclusion Criteria:\n\n* ≥18yrs.\n* Participants able to communicate with staff and safely comply with the study procedures.\n* Participants to provide informed written consent.\n\nExclusion Criteria:\n\n* Participants with any MRI contraindications including inability to lie flat in MRI scanner, claustrophobia and no foreign bodies, medical devices or other items which are considered an MRI contraindication.\n* Geographically remote patients unable to agree to imaging schedule.\n* Participants with illness or condition which means they cannot understand the requirements of the study.\n* Participants with cardiac or pulmonary disease that are unable to tolerate the flow of oxygen delivered via a mask.\n* Participants who have previously been treated with bleomycin (a chemotherapy used to treat some cancers including Hodgkin lymphoma and germ cell tumours).\n* Participants with contraindications to gadolinium-based contrast agent",true,{"count":57,"type":19},25,[59],"NA","High-grade gliomas (HGGs) are the most common type of brain cancer in adults. Life expectancy for patients with HGGs is low. Radiotherapy aims to cure the tumour, but this is hard because HGGs are resistant to treatment. Among the possible causes of resistance may be tumour cells with low-oxygen levels (hypoxia). The investigators know that hypoxia reduces tumour sensitivity to radiotherapy. Using a special imaging technique called oxygen-enhanced MRI (OE-MRI), the investigators can try to identify areas of the tumour with hypoxia. The investigators could then give those areas a higher dose of radiotherapy. This might improve tumour control. This study aims to see if OE-MRI can find low-oxygen areas in HGGs. The study will also assess whether higher radiotherapy doses can be simulated in these regions.\n\nProject summary:\n\n1. Set up the OE-MRI process at Leeds Cancer Centre (LCC). OE-MRI settings will be tested on healthy volunteer participants to ensure the images are as good as possible.\n2. Participant Imaging. Patient participants with HGG will be recruited to take part. OE-MRI will be used to image participants during their treatment and track low-oxygen areas before treatment, halfway through treatment and 3 months after treatment has finished.\n3. Dose Escalation Assessment. Computer programs will be used to design radiotherapy treatments to test if higher radiation doses to the tumour's low-oxygen areas can better control the cancer. This will help understand if this targeted approach has potential benefits. This is modelling and will not alter routine clinical patient participant management.",[29,62,63,64],"Hypoxia Brain","Glioblastoma (GBM)","Brain Neoplasms, Adult",[66,67,68,69,70,71],"Oxygen-enhanced MRI","OE-MRI","Functional MRI","Hypoxia imaging","Quantitative MRI","Tumour hypoxia","NOT_YET_RECRUITING","2026-06-26",{"date":75,"type":39},"2026-06-30",{"date":77,"type":19},"2026-09-01",{"date":79,"type":19},"2028-10-31",{"name":81,"class":46},"The Leeds Teaching Hospitals NHS Trust",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":15,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":20,"phases":93,"briefSummary":95,"conditions":96,"keywords":102,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100644286","phase-1-ngfus-nivo-neuronavigation-guided-focused-ultrasound-with-nivolumab-in-relapsed-and-progressive-dmg-and-other-high-grade-brain-tumors-100644286","NCT07664176","NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors","A Safety and Feasibility Study of NeuroNavigation-Guided Low Intensity Focused Ultrasound With Microbubbles to Enhance Nivolumab Delivery for the Treatment of Relapsed and Progressive Diffuse Midline Glioma and Other High Grade Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 3 and ≤ 25 years.\n* Diagnosis of brainstem DMG\u002FDIPG or any high-grade brain tumor.\n\n  * Group A: Relapsed or progressive brainstem DMG.\n  * Group B: Relapsed or progressive high-grade intracranial brain tumor requiring surgical resection.\n* Lansky\u002FKarnofsky rating ≥ 60.\n* Patients must have received at least one line of prior therapy upfront for their disease.\n* At least four weeks from radiation therapy, prior immunotherapy, or monoclonal antibody therapy.\n* At least 2 weeks from prior myelosuppressive chemotherapy and post nadir meeting organ function criteria.\n* At least 1 week or 5 half-lives (whichever is longer) from last targeted therapy.\n* If on steroids, stable or decreasing dose for at least 7 days prior to study entry and ≤ 0.4 mg\u002Fm2\u002Fday of dexamethasone or equivalent.\n* Stable or improving neurological status for 7 days prior to study entry.\n* Organ function:\n\n  * Absolute Neutrophil Count (ANC) ≥750\u002FμL.\n  * Absolute Lymphocyte Count (ALC) \\>500\u002FμL.\n  * Platelets ≥75K, unsupported.\n  * Coagulation studies: PT and PTT \\\u003C1.5 ULN and INR (\\\u003C1.5).\n  * Bilirubin ≤1.5x upper limit of normal (ULN).\n  * AST\u002FALT ≤5x ULN.\n  * Serum creatinine within normal limits for age.\n  * Pulse oximetry \\>93% on room air.\n  * Ejection Fraction (EF) above institutional lower limit of normal (LLN).\n* For females of childbearing potential (FOCBP): negative pregnancy test within 7 days of study entry.\n* Patients of childbearing or child-fathering potential must agree to use contraceptive measures for at least 5 months following nivolumab infusion.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nExclusion Criteria:\n\n* Symptoms and signs of increased intracranial pressure.\n* Patients with metallic ventricular peritoneal shunts. Subjects with nonmetallic VP shunts or similar will have a technical evaluation of the screening non-contrast CT scan of the head. During the mapping of the target area, if the technical NaviFUS specialist determines that the patient cannot be treated within the safety limits of the system, the patient will not be eligible and will be considered a screen failure.\n* Tumor presenting with the following imaging characteristics:\n\n  * Evidence of uncal herniation.\n  * Edema and\u002For mass effect that causes hydrocephalus.\n  * Significant areas of necrosis within the tumor that the neurosurgeon feels cannot be avoided during the ultrasound sonication.\n  * Evidence of a significant new hemorrhage. Area of microhemorrhage (defined as less than 5 mm in diameter) in the treatment area can be acceptable but requires the review of the neurosurgeon.\n  * Containing calcifications in the focused ultrasound sonication beam path and system tools cannot tailor the treatment around these calcification spots.\n  * Patients who are deemed to have overly bulky tumor by the PI of the study.\n* The sonication pathway to the tumor involves:\n\n  * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.\n  * Clips, or other non-MRI compatible metallic implanted objects in the skull or the brain, except for shunts.\n* Patients receiving anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs \\[NSAIDs\\], statins). There is no required washout for eligibility assessment, but patients should be off agents for at least 3 days at the time of procedure or until 5 half-lives of the agent, whichever is longer.\n* History of a bleeding disorder, coagulopathy or with a history of clinically significant spontaneous tumor hemorrhage.\n* Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis.\n* Immunosuppression (corticosteroids to prevent\u002Ftreat brain edema are permitted).\n* Patients with uncontrolled HIV.\n* Active seizure disorder or epilepsy (clinically significant seizures despite medical treatment) within four weeks prior to first cycle\u002FNaviFUS BBBO procedure captured by history.\n* Known sensitivity to gadolinium-based contrast agents.\n* Known sensitivity to Lumason® ultrasound contrast agent or known hypersensitivity to sulphur hexafluoride microsphere or its components, e.g., polyethylene glycol.\n* Patients unable to fit comfortably into the MRI scanner (generally \\>250 lbs.).\n* Evidence of cranial or systemic infection.","3 Years","25 Years",{"count":92,"type":19},30,[94],"PHASE1","This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors. This study combines intravenous nivolumab therapy infused following transient blood-brain barrier opening (BBBO) using low-intensity focused ultrasound with microbubble (LIFU-MB) treatment using NeuroNavigation-Guided Focused Ultrasound (NgFUS).\n\nThere are two groups in this study:\n\n* Group A: Patients with relapsed or progressive diffuse midline glioma in the brainstem\n* Group B: Patients with relapsed or progressive high grade brain tumor that clinically require surgical resection\n\nThe primary outcome is to evaluate the safety and feasibility of 3 cycles of nivolumab with BBB disruption using NgFUS with microbubbles in pediatric patients with progressive or relapsed brainstem DMG or with high grade brain tumors after surgery. Secondary outcomes include preliminary efficacy and immunological effects.",[97,29,98,99,100,101],"Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma","Medulloblastoma Recurrent","Ependymoma Recurrent","Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS","Brain Tumor Recurrent",[103,104,105,106,107,108,28,26,109],"Focused Ultrasound","Pediatrics","Diffuse Midline Glioma","DMG","Diffuse Intrinsic Pontine Glioma","DIPG","Nivolumab","2026-06-17",{"date":112,"type":39},"2026-06-24",{"date":114,"type":19},"2026-06-01",{"date":116,"type":19},"2030-12",{"name":118,"class":46},"Children's National Research Institute",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":15,"minAge":89,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":20,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":47},"100641798","phase-2-phase-2-trial-of-g207--5-gy-radiation-for-children-with-high-grade-gliomas-100641798","NCT07649070","Phase 2 Trial of G207 + 5 Gy Radiation for Children With High-Grade Gliomas","Inclusion Criteria:\n\nExclusion Criteria:\n\nPregnancy\n\nPregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nPregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects.\n\nLactation Status\n\nLactating females are not eligible unless they have agreed not to breastfeed their infants\n\nBecause there is an unknown potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G207.\n\nDisease-Related Exclusion Criteria\n\nPatients 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\nPatients with primary tumor involving the cerebellum, brainstem or spinal cord, or that would require surgical access through a ventricle to deliver the prescribed protocol treatment.\n\nMetastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain.\n\nTumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation.\n\nConcurrent Illness\n\nPatients 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 undergo surgery and\u002For tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n\nKnown HIV seropositivity.\n\nDiagnosis of encephalitis or CNS infection \\\u003C 12 weeks prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis.\n\nConcurrent Medications\n\nPatients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n\nPatients who are receiving ≥ 2 mg of dexamethasone (or ≥ 10 mg of prednisone) daily\n\n* Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation\n* 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), intermittent use of bronchodilators and topical steroids, is not considered immunosuppressive and does not constitute exclusion.\n\nConcurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).\n\nInability to Participate\n\nPatients who in the opinion of the investigator are unwilling or unable to return for required followup visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to the drug administration plan, other study procedures, and study restrictions.","21 Years",{"count":18,"type":19},[128],"PHASE2","The goal of this clinical research study is to learn about the safety and effects of G207 combined with radiation therapy in patients with recurrent or progressive high-grade glioma (HGG).",[29],"2026-06-12",{"date":133,"type":39},"2026-06-15",{"date":135,"type":19},"2026-11-30",{"date":137,"type":19},"2032-12-31",{"name":139,"class":46},"M.D. Anderson Cancer Center",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":20,"phases":151,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":173},"100619555","phase-1-study-of-an-aav-mediated-dual-payload-gene-therapy-in-patients-with-high-grade-glioma-100619555","NCT07346144","Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","A Phase I\u002FII Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","ADePT","Inclusion Criteria:\n\n* Aged 18-70 years\n* Karnofsky performance status ≥70\n* Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI\n* Recurrent patients: First radiological progression (as determined by the multidisciplinary team \\[MDT\\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological\u002Fmolecular diagnosis of GBM\n* Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)\n* Debulking surgery is indicated for optimal patient care\n* Able to swallow oral medication\n* Willing to avoid live vaccines\n* Adequate organ function\n* Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0.\n* All patients must agree to practice true abstinence or to use highly effective contraception\n* Patient is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patient who is pregnant, lactating or planning pregnancy during the course of the study\n* Immunodeficiency or active auto-immune disease requiring systemic therapy.\n* Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery\n* Live vaccine within 28 days prior to Day 0\n* Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0\n* History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection\n* Received previous treatment with a gene therapy\n* Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment\n* Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted\n* Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007\n* Contraindication to MRI with gadolinium\n* Any condition expected to interfere with the intended timing of debulking surgery\n* Previous non-glioma cancer within 3 years (other than treated squamous\u002Fbasal cell skin cancer, treated early-stage cervical cancer or treated\u002Fbiochemically stable, organ confined prostate cancer)\n* Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study\n* Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product\n* Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the study\n* Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study\n\nNewly diagnosed patients only:\n\n* Any prior therapy for glioma\n* Intended use of tumour treating fields\n\nRecurrent patients only:\n\n* Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity\n* Intended use of tumour treating fields","70 Years",{"count":150,"type":19},68,[94,128],"The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma.\n\nTGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour.\n\nPatients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery.\n\nThe study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM.\n\nApproximately 68 people aged 18-70 will take part in the study.",[63,29,154,155],"Recurrent Glioblastoma","Newly Diagnosed Glioblastoma",[157,158,159,160,161,162,163],"Glioblastoma","Immunotherapy","Gene Therapy","AAV","HSV-tk","IL-12","TGX-007","2026-06-11",{"date":131,"type":39},{"date":167,"type":39},"2026-04-21",{"date":169,"type":19},"2033-09",{"name":171,"class":172},"Trogenix ltd","INDUSTRY",2,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":15,"minAge":89,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":20,"phases":183,"briefSummary":184,"conditions":185,"keywords":202,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":47},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.",{"count":57,"type":19},[94,128],"Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[186,187,188,29,189,190,191,192,193,108,157,63,194,195,196,197,198,199,98,200,201,99],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Paraganglioma\u002F Phaeochromocytoma","Ependymoma",[203,204,205,206,207,208,209,210,211,212,213,214,215,108,216,217,218,219,220,221,222,223,224,201,225],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","2026-06-02",{"date":228,"type":39},"2026-06-04",{"date":230,"type":39},"2024-09-20",{"date":232,"type":19},"2029-12",{"name":234,"class":46},"Fundación de investigación HM",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":15,"minAge":89,"maxAge":125,"enrollmentInfo":243,"targetDuration":4,"studyType":20,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":47},"100594313","early-phase-1-a-phase-01-study-of-cdna-for-tp53-checkpoint-inhibition-and-radiation-in-children-with-recurrent-progressive-or-refractory-cns-malignancies-100594313","NCT07017816","A Phase 0\u002F1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.","JACOB: Joint Administration of cDNA for TP53, checkpOint Inhibition and Boost\u002FHypofractionated Radiation. A Phase 0\u002F1 Study in Children With Recurrent, Progressive or Refractory CNS Malignancies.","JACOB","Inclusion Criteria:\n\n* Tumor\n\n  a. Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options.\n\n  i. Medulloblastoma, ATRT, High grade gliomas, pineoblastomas, embryonal tumors NOS, CNS sarcomas, ependymomas, other high-grade malignancies that failed first line therapies.\n\nii. Patients should have received radiation for standard up-front therapy. iii. Patients must have received at least one line of standard of care treatment without limitation to the number of treatments received. b. Evidence of clinical and\u002For radiological progressive disease as defined by RAPNO criteria.\n\nc. Patients with metastatic disease are eligible d. Patients must have available archival (formalin-fixed paraffin embedded) or fresh tumor tissue for correlative studies.\n\n* Patient Characteristics a. The first 3 patients will be \\>7 years old to \\\u003C22 years old i. Following initial successful treatment of the first 3 patients: Patients must be ≥3yrs and \\\u003C22 years of age.\n\n  b. Must have recovered from all surgical interventions prior to the start of the radiation and maintenance phases c. Patients must have a BSA of 0.6m2 or more to be enrolled. 3. Previous treatment\n  1. Patients must have recovered from the acute effects of prior therapy. Adverse events resulting from prior surgical intervention will not be an ineligibility criterion.\n  2. Chemotherapy: Patients must have received their last dose of known chemotherapy at least two (2) weeks prior to receipt of SGT-53.\n  3. Biologic therapy: Patients must have received their last dose of biological agent \\>7 days prior to receipt of SGT-53.\n  4. Radiation therapy: Patients must be deemed to be a reasonable candidate for hypofractionated irradiation from a clinical standard of care perspective.\n\n  i. At least 3 months from craniospinal radiation therapy, ii. Other substantial bone marrow irradiation ≥6 weeks prior to enrollment, iii. Local palliative XRT (small volume) ≥2 weeks. iv. if progressive disease is documented by radiological evidence of disease in areas not previously radiated, no minimum time required.\n\n  e. Corticosteroids: Patients who are receiving dexamethasone or other corticosteroids must be on a stable or decreasing dose for at least one (1) week prior to enrollment. There will be a maximum allowable steroid dose of 0.5mg\u002Fm2\u002Fday dexamethasone equivalents f. Growth factors: Patients must have received their last dose of any short acting growth factor at least one week prior to treatment, for long acting or pegylated growth factors, the last dose must be at least two (2) weeks prior to start of treatment.\n\n  4\\. Neurologic Status\n\n  a. Patients should be at their neurological baseline for a minimum of one week prior to enrollment.\n\n  5\\. Performance Status\n\n  a. Performance status (KarnofskyPS for \\>16yrs, or Lansky PS for \\\u003C16yrs) assessed within two weeks must be \\>50.\n\n  i. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for assessing the performance score.\n\n  6\\. Organ Function - Patients must have normal organ and marrow function as defined below:\n  1. Absolute neutrophil count \\>750\u002Ful\n  2. Platelets ≥75,000\u002Ful\n  3. Hemoglobin ≥8g\u002FdL (may be supported with transfusion)\n  4. Total bilirubin ≤1.5x ULN\n  5. ALT\u002FAST ≤3x ULN\n  6. Serum albumin ≥2g\u002FdL\n  7. Normal cardiac function defined as ejection fraction within normal limits for age and gender\n  8. a serum creatinine based on age\u002Fgender as below or a creatinine clearance or serum GFR ≥ 70ml\u002Fmin\u002F1.73m2: Serum Creatinine for age\u002Fsex Age Maximum Serum Creatinine (mg\u002FdL) Male Female\n\n     1. \\\u003C2 years 0.6 0.6\n     2. \\\u003C6 years 0.8 0.8\n\n     6-\\\u003C10 years 1 1 10-\\\u003C13 years 1.2 1.2 13- \\\u003C16 years 1.5 1.4 \\> 16 years 1.7 1.4 The threshold creatinine values in this table were adapted from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds 106:.522, 1985) utilizing child length and stature data published by the CDC.\n\n     7\\. Pregnancy prevention- all patients of childbearing or child fathering potential must be willing to use an acceptable form of birth control while being treated on this study and at least 5 months after receiving the last study treatment.\n\n     8\\. Pregnancy status: Female patients must not be pregnant or nursing. Female patients of reproductive potential must also have a negative serum pregnancy test at the time of enrollment.\n\n     9\\. Informed Consent - Patient and\u002For guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.\n\n     Exclusion Criteria:\n* 1\\. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.\n\n  2\\. Patients with diagnosis of diffuse midline gliomas (DMGs) are excluded. 3. Patients with any clinically significant unrelated systemic illness (serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that is likely to interfere with ability to tolerate study therapy or study procedure results.\n\n  4\\. Patients with pre-existing cardiac dysfunction defined as baseline EF of less than 35% 5. Patients with pre-existing pulmonary fibrosis, interstitial lung disease, and clinically significant pulmonary lung disease.\n\n  6\\. Patients who are receiving any other investigational drug therapy 7. Patients who in the opinion of the investigator cannot adhere to protocol requirements 8. Patients with history of autoimmune diseases that required treatment in the last 2 years are not eligible. Asymptomatic laboratory abnormalities (e.g. ANA, rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder. Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy) is not considered a form of systemic treatment.\n\n  9\\. Patients who have received a live vaccine within 30 days of start of study treatment are not eligible.\n\n  10\\. Patients with known HIV\u002FAIDS or acute\u002Fchronic Hepatitis B or C are excluded.\n\n  11\\. Patients who are prohibited from receiving radiation therapy (reached maximum lifetime dose) are not eligible.",{"count":244,"type":19},18,[22],"This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments. The main questions it aims to answer are:\n\nWhat is the right dose of SGT-53 that children can safely receive when it is used with radiation and Nivolumab? This dose will be used in the second phase of the trial.\n\nWhat side effects are there of SGT-53 when it is used with radiation and Nivolumab?\n\nHow does SGT-53 move through the body when given with radiation and Nivolumab?\n\nHow much of the SGT-53 drug is found in the tumor tissue? This will be tested in a small group of patients?\n\nParticipants will:\n\nFor the first treatment cycle:\n\nGet SGT-53 twice per week Get Nivolumab every 2 weeks Receive radiation therapy during week 2\n\nFor Cycles 2-6:\n\nGet SGT-53 once per week during even cycles and twice per week during odd cycles Get Nivolumab every 2 weeks For Cycles 7+ Get both SGT-53 and Nivolumab every 2 weeks In the phase 0 part of the study, 4 participants will have genetic testing performed on their tumor tissue after receiving SGT-53. These samples will be compared to another sample taken from the skin.",[248,98,249,250,251,99,29],"CNS Malignancies","ATRT Recurrent","Pineoblastoma","Embryonal Neoplasm","2026-04-24",{"date":254,"type":39},"2026-04-29",{"date":256,"type":39},"2025-12-16",{"date":258,"type":19},"2028-05-01",{"name":118,"class":46},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":20,"phases":270,"briefSummary":271,"conditions":272,"keywords":276,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":47},"100635334","phase-1-dual-targeting-car-nk-cells-for-recurrentprogressive-glioblastoma-and-high-grade-glioma-100635334","NCT07551336","Dual-Targeting CAR-NK Cells for Recurrent\u002FProgressive Glioblastoma and High-Grade Glioma","A Phase 1, First-in-Human, Biomarker-Guided, Dose-Escalation and Expansion Study of Locoregional Dual-Targeting CAR-NK Cells Directed Against IL13Rα2, EGFR\u002FEGFRvIII, and\u002For B7-H3 (CD276) in Adults With Recurrent or Progressive Glioblastoma or High-Grade Glioma","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically confirmed glioblastoma (WHO grade 4) or diffuse high-grade glioma (WHO grade 3 or 4) that is recurrent or progressive after standard therapy.\n* Planned clinically indicated tumor resection or stereotactic biopsy (or availability of adequate archived tumor tissue) to support antigen testing and locoregional catheter placement.\n* Tumor demonstrates expression of at least two of the following antigens above protocol-defined thresholds: IL13Rα2, EGFR (wild-type) and\u002For EGFRvIII, B7-H3 (CD276).\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Adequate organ function (hematologic, renal, hepatic) as defined by protocol laboratory criteria.\n* Ability to undergo brain MRI with contrast (unless contraindicated and alternative imaging is permitted).\n* Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled bacterial, viral, or fungal infection).\n* Known HIV infection with uncontrolled viral load; active hepatitis B or hepatitis C with detectable viral load (unless permitted per protocol).\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Requirement for high-dose systemic corticosteroids (e.g., \\>4 mg\u002Fday dexamethasone equivalent) within 7 days prior to lymphodepletion\u002Finfusion (physiologic replacement permitted).\n* Prior gene-modified cellular therapy (e.g., prior CAR-T\u002FCAR-NK) within 6 months, or prior therapy targeting IL13Rα2, EGFR\u002FEGFRvIII, or B7-H3 where residual engineered cells could confound safety assessments.\n* Diffuse leptomeningeal disease as the only site of disease, or anatomy that precludes safe catheter placement (unless specifically allowed by protocol).\n* Uncontrolled seizures despite optimal medical therapy.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk with lymphodepletion or infusion procedures.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or could interfere with protocol adherence.","75 Years",{"count":269,"type":19},36,[94],"This is a draft, ClinicalTrials.gov-style example record for a first-in-human Phase 1 study evaluating locoregional administration of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in adults with recurrent or progressive glioblastoma (GBM) or other high-grade glioma (HGG). Participants will undergo tumor antigen profiling for IL13Rα2, EGFR\u002FEGFRvIII, and B7-H3 (CD276). Based on this assessment, each participant will receive the most suitable dual-target CAR construct to reduce antigen-escape risk.",[273,274,157,275,154],"Malignant Glioma","High-Grade Gliomas","Recurrent High-Grade Gliomas",[277,278,279,280,281,282,283,284,285,286],"CAR-NK","Dual targeting","Biomarker-guided","IL13Rα2","EGFR","EGFRvIII","B7-H3 (CD276)","Locoregional","Intracavitary","Ommaya reservoir","2026-04-18",{"date":252,"type":39},{"date":290,"type":39},"2026-03-02",{"date":292,"type":19},"2028-04-17",{"name":294,"class":172},"Beijing Biotech",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":20,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":4},"100626710","phase-2-pre-radiation-chemotherapy-for-newly-diagnosed-high-grade-glioma-100626710","NCT07439172","Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.","A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation","PRC","Inclusion Criteria:\n\n1. Pathologic diagnosis of high-grade glioma\n2. Residual measurable post-operative contrast enhancing tumor\n3. Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)\n4. Ability to provide informed consent\n5. Willingness to comply with all study procedures and availability for the duration of the study\n6. Male or female, aged 18-80.\n7. Karnofsky Performance Status ³70%.\n8. Patients must have the following organ and marrow functions:\n\n   Absolute neutrophil count ≥1,500\u002FµL Platelets ≥100,000\u002FµL Hemoglobin ≥ 9 g\u002FdL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)\u002FALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73m2 APTT\u002FPTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal\n9. Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen\n10. For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration\n11. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner\n12. Patients must have measurable disease as defined by RANO criteria.\n\nExclusion Criteria:\n\n1. Patients receiving any other investigational agents are ineligible.\n2. Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.\n3. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.\n4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible.\n5. Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.","80 Years",{"count":305,"type":19},70,[128],"Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read.\n\nFirst, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.",[29,157,309,310],"Astrocytoma","Oligodendroglioma",[27,157,28,312,309,310,313],"Brain Tumor","Temozolomide","2026-02-23",{"date":316,"type":39},"2026-02-27",{"date":318,"type":19},"2026-03",{"date":320,"type":19},"2029-09",{"name":322,"class":46},"The Cooper Health System",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":15,"minAge":331,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":20,"phases":334,"briefSummary":335,"conditions":336,"keywords":339,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":4},"100618395","phase-1-gallium-maltolate-for-the-treatment-of-pediatric-patients-with-relapsed-or-refractory-pediatric-high-grade-glioma-and-atypical-teratoid-rhabdoid-tumor-100618395","NCT07331064","Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor","A Phase 1 Clinical Trial of Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor","GABRIEL","Inclusion Criteria:\n\n1. Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\n2. Patients must have a prior histological diagnosis of pediatric high-grade glioma (WHO Grade 3 or 4, including DMG\u002FDIPG) or ATRT (WHO Grade 4) or molecular features of such tumors (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).\n3. Patients are required to have received standard treatment for their tumor type which is considered to include at least:\n\n   a. pHGG (including DIPG\u002FDMG): maximum safe resection, focal radiotherapy. i. Addition of temozolomide, bevacizumab, or lomustine are considered of standard of care but not a requirement for inclusion.\n\n   ii. Addition of sites of radiotherapy to include all areas of disease as needed are considered standard of care but not a requirement for inclusion.\n\n   b. ATRT: maximum safe resection, radiotherapy (focal or craniospinal), and combination chemotherapy per a nationally-accepted ATRT regimen (such as DFCI-ATRT, COG ACNS0334, or MUV-ATRT).\n4. Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.\n\n   1. Cytotoxic chemotherapy (given systemically or intraventricular\u002Fintrathecal) or other anti-cancer agents known to be myelosuppressive ≥21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).\n   2. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): ≥7 days after the last dose of agent.\n   3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤1 (for purposes of this study, bevacizumab is considered an antibody).\n   4. Corticosteroids:\n\n   i. If used to modify immune adverse events related to prior therapy, ≥14 days must have elapsed since last dose of corticosteroid.\n\n   ii. If used for symptom management related to tumor edema or elevated ICP, patient should be on a stable dose of corticosteroid for ≥7 days.\n\n   e. Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for short-acting growth factor.\n\n   f. Autologous stem cell infusion, including boost infusion: ≥42 days g. Cellular therapy: ≥42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells) h. h. Radiation therapy (XRT)\u002Fexternal beam irradiation including protons: ≥14 days after local XRT; ≥30 days after whole brain or craniospinal XRT.\n5. Patients must have measurable disease that can be assessed for response to treatment as defined by RAPNO for high-grade gliomas (59), RAPNO for DIPG (60), or RAPNO for medulloblastoma and other leptomeningeal seeding tumors (for ATRT) (61) that incorporates MRI assessment and clinical factors. In the absence of measurable disease, pathologic confirmation of recurrent disease is required (i.e., positive cerebrospinal fluid cytology).\n6. Male or female subjects must be 0-17 years of age.\n7. Lanksy\u002FKarnofsky performance status ≥50 (refer to Appendix 1). Subjects who are wheelchair-bound because of paralysis will be considered \"ambulatory\" when they are up in their wheelchair.\n8. Patients must have adequate bone marrow function as evidenced by:\n\n   1. An absolute neutrophil count (ANC) of \\>1,000\u002FµL (stable off any growth factor within one week of study drug administration.\n   2. Hemoglobin \\>8 g\u002FdL.\n   3. Platelet count \\>100,000\u002FµL without transfusion within one week.\n9. Patients must have adequate hepatic and renal function based on the following laboratory tests:\n\n   1. ALT ≤ 2 x ULN\n   2. AST ≤ 2 x ULN\n   3. Alkaline phosphatase ≤ 2 x ULN\n   4. Total bilirubin ≤ 2 x ULN\n   5. Adequate kidney function (as defined by eGFR \\>60 mL\u002Fmin\u002F1.72m2 as calculated by the Bedside Schwartz equation)\n10. Patients must be able to swallow liquid (suspension) medication, or have nasogastric or gastric tube present to give medication.\n11. Female subjects must meet one of the following:\n\n    1. Premenstrual OR\n    2. If subject is of childbearing potential, agree to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21 days after the last dose of study agent, OR\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n12. Male subjects of child-fathering potential must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR\n    2. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n13. Patients taking oral iron supplements or iron chelators must discontinue these medications at least one week prior to starting GaM since these agents may impact on the efficacy of GaM. Drug-drug interactions between GaM and other concomitant medications have not been reported.\n\nExclusion Criteria:\n\n1. Presence of other active malignant disease diagnosed within 12 months.\n2. Not appropriately recovered from prior therapy as defined by time frames listed in the inclusion criteria (Section 4.5.2.1).\n3. Known hypersensitivity to or intolerance to gallium-based medications.\n4. Concurrent use of cytotoxic chemotherapy is not permitted.\n5. Unstable or severe concurrent medical conditions such as severe heart disease, renal failure, uncontrolled diabetes mellitus, or severe lung disease.\n6. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.\n7. Patients who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.\n8. Inability to tolerate an oral medication.\n9. Patients who are pregnant or nursing.\n10. Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.","0 Months","17 Years",{"count":5,"type":19},[94],"In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.",[29,337,105,108,338],"Atypical Teratoid Rhabdoid Tumors (ATRT)","Diffuse Intrinsic Pontine Gliomas (DIPG)",[108,26,340,106,341,342,343,34,344,345,346,347,348],"ATRT","relapse","refractory","progressive","diffuse midline glioma","diffuse intrinsic pontine glioma","atypical teratoid rhabdoid tumor","brain tumor","pediatric","2025-12-29",{"date":351,"type":39},"2026-01-09",{"date":353,"type":19},"2026-05-15",{"date":355,"type":19},"2031-05-15",{"name":357,"class":46},"Sarah Rumler",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":148,"enrollmentInfo":365,"targetDuration":4,"studyType":20,"phases":366,"briefSummary":367,"conditions":368,"keywords":371,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":47},"100517501","phase-1-clinical-study-on-the-treatment-of-malignant-brain-glioma-by-qh104-cell-injection-100517501","NCT06018363","Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection","Allogeneic B7-H3 CAR-γδT Cell Therapy Recurrent\u002FProgressive High Grade Glioma（R\u002FR HGG）","Inclusion Criteria:\n\n* 1)Age 18-70 years old (both ends included), both male and female;\n* 2)At least one evaluable lesion, with previous biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4), and after comprehensive treatment, imaging examination indicates continued progression or recurrence;\n* 3\\) The pathological tissues removed by surgery can be used for immunohistochemical detection of target proteins (paraffin sections should be within half a year), and the expression of B7-H3 is positive;\n* 4\\) KPS ≥ 60 points;\n* 5)Expected survival \\> 3 months;\n* 6)Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before receiving QH104 Cell Injection for the first time):White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL;Lymphocyte count (LY) ≥ 0.8 x 10\\^9\u002FL;Hemoglobin (Hb) ≥ 90g\u002FL;Platelet (PLT) ≥80×10\\^9\u002FL;Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C1.5×ULN;Serum creatinine (Cr) \\\u003C1.5 x ULN;Total bilirubin \\\u003C 1.5 x ULN;PT \\& PTT ≤ 1.25 x ULN.\n* 7)No obvious hereditary diseases;\n* 8)Normal cardiac function with cardiac ejection index \\>55%;\n* 9)No bleeding and coagulation disorders;\n* 10)Women of childbearing age (15-49 years old) must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception during the clinical trial and for 3 months after the last cell infusion;\n* 11\\) Sign the informed consent form.\n\nExclusion Criteria:\n\n* 1)Pregnant and lactating women;\n* 2)Those with organ failure:Heart: Class III and IV;Liver: up to grade C of the Child-Turcotte Liver -Function Classification;Kidney: chronic kidney disease stage 4 or above; renal insufficiency stage III or above;Lungs: symptoms of severe respiratory failure with involvement of other organs;Brain: central nervous system abnormalities or impaired consciousness;\n* 3)patients with combined second tumors;\n* 4)patients with active hepatitis B or C virus, HIV infection, or other untreated active infection;\n* 5)any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis;\n* 6)Current systemic use of steroid cell (except for recent or current use of inhaled steroids) substances;\n* 7\\) have a chronic disease requiring immunologic or hormonal therapy;\n* 8\\) have an allergy to immunotherapy and related cells;\n* 9\\) 10)Patients with a history of organ transplantation or who are awaiting organ transplantation;\n* 10)Participation in other clinical trials within the previous 30 days;\n* 11)Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.",{"count":57,"type":19},[94,128],"B7-H3 is expressed at low levels in normal tissues but overexpressed in various tumor tissues. The ubiquitous expression of B7-H3 in tumors of different grades is a key feature for brain gliomas. The immunohistochemistry study showed that B7-H3 is abundantly expressed on both glioma (especially high-grade glioma) cells and tumor-associated endothelial cells. For GBM, the expression of B7-H3 is intensely positive, especially on tumor cells and vascular endothelial cells, which makes B7-H3 a potential immunotherapeutic target.\n\nγδ T cells recognize tumor cells without being restricted by MHC molecules, and thus can be used in allogeneic therapy without the risk of causing graft-versus-host disease.\n\nThis study is an open-label, single-arm, dose-escalation and dose-expansion clinical study aimed at evaluating the safety and efficacy of allogeneic B7-H3 CAR γδT in patients with malignant glioma.",[369,274,370],"Brain Gliomas","GBM",[372,373,374],"B7-H3","CAR-γδT","allogeneic","2025-08-13",{"date":377,"type":39},"2025-08-19",{"date":379,"type":39},"2023-06-01",{"date":381,"type":19},"2027-12-31",{"name":383,"class":46},"Dushu Lake Hospital Affiliated to Soochow University",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":15,"minAge":391,"maxAge":125,"enrollmentInfo":392,"targetDuration":4,"studyType":20,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100597679","phase-1-determine-maximum-tolerated-dose-safety-and-tolerability-of-rhenium-186re-in-pediatric-recurrent-refractory-or-progressive-ependymoma-and-high-grade-glioma-100597679","NCT07061626","Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma","A Two-Part, Phase 1\u002F2a Trial to Determine the Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Delivered Via Convection Enhanced Delivery (CED) in Supratentorial Recurrent, Refractory, or Progressive Pediatric Ependymoma and High-Grade Glioma (HGG)","Inclusion Criteria:\n\n1. 6 years to 21 years\\* of age.\n2. Lesion number and size:\n\n   1. Phase 1a\u002Fb only: A single lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor (subsequent to individual Cohort lesion size requirements).\n   2. Phase 2a only: A single lesion or any number of multiple lesions separated by (less than or equal to) ≤3 cm; each lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor.\n3. Diagnosis:\n\n   a) Documented recurrent, refractory, or progressive ependymoma or HGG not eligible for resection or no longer receiving standard of care.\n\n   i) Phase 2a only: May include patients with recurrent, refractory, or progressive ependymoma or HGG where SOC surgery could be safely delayed four (4) weeks post-infusate.\n\n   b) Documented histologically confirmed high-grade glioma \\[following 2021 WHO CNS5 glioma nomenclature, e.g., Anaplastic astrocytoma, Anaplastic pleomorphic xanthoastrocytoma (PXA), Anaplastic ganglioglioma, Anaplastic oligodendroglioma, Glioblastoma, Diffuse midline glioma, H3K27M mutant\\].\n4. Karnofsky Performance Status ≥ 60. For subjects \\\u003C16 years of age, Lansky score ≥ 60.\n5. Acceptable liver function:\n\n   1. Bilirubin ≤ 1.5 times the upper limit of normal\n   2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal (ULN)\n\n      6\\) Acceptable renal function:\n\n   \u003C!-- -->\n\n   1. Serum creatinine ≤1.5xULN\n\n7\\. Acceptable hematologic status (without hematologic support):\n\n1. ANC ≥1000 cells\u002FuL\n2. Platelet count ≥100,000\u002FuL\n3. Hemoglobin ≥9.0 g\u002FdL\n\n   8\\. All subjects of childbearing potential must have a negative serum pregnancy test, and subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.\n\n   9\\. Life expectancy of at least 2 months.\n\n   \\*Will consider treatment of subjects up to 25 years of age on a per-patient basis if no other co-morbidities are present that require subspecialty consultation outside of neurosurgical and oncologic care.\n\nExclusion Criteria:\n\n1. Spinal disease.\n2. Infratentorial location of tumor.\n3. Involvement of the leptomeninges.\n4. Serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes such as:\n\n   1. Hypertension (two or more blood pressure readings performed at screening of systolic blood pressure (SBP) or diastolic blood pressure (DBP) above 95th percentile for age) despite optimal treatment.\n   2. Active medically significant infection unresponsive to antibiotics (e.g., non-healing wound, ulcer), uncontrolled systemic infection, or bone fracture.\n   3. Clinically significant cardiac arrhythmias.\n   4. Untreated hypothyroidism.\n   5. Congestive heart failure.\n   6. Myocarditis.\n   7. Inherited bleeding diathesis or coagulopathy with the risk of bleeding.\n   8. Known active malignancy other than ependymoma or high-grade glioma.\n5. Any of the following prior anticancer therapy:\n\n   1. Prior treatment with Bevacizumab or other VEGF agents within 12 months prior to study registration.\n   2. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site at any time prior to study registration.\n   3. Standard radiation therapy within 12 weeks prior to study registration.\n   4. Any systemic therapy within 28 days or 2 half-lives, whichever is longer, prior to study registration (this may include investigational agents, small-molecule kinase inhibitors, non-cytotoxic hormonal therapy, biologic agents, metronomic\u002Fprotracted low-dose chemotherapy, etc.).\n   5. Nitrosoureas or mitomycin C within 42 days prior to study registration.\n6. Psychiatric illness\u002Fsocial situations that would limit compliance with the study requirements.\n7. A tumor located within 1.0cm of a ventricle AND it is determined by the surgeon, PI, and Sponsor to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug administration.\n8. A tumor within 1.5cm of critical structures, including the optic chiasm, optic nerves, or brainstem.\n9. Evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan (subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible).\n10. Treatment with antiepileptic medications must have a two-week history of a stable dose of antiepileptic without seizures prior to study registration.\n11. Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms prior to study registration.","6 Years",{"count":393,"type":19},56,[94],"Pediatric patients 6-21 years of age with supratentorial recurrent, refractory, or progressive pediatric ependymoma and high-grade glioma (HGG) will be included in this study of treatment with Rhenium-186 Nanoliposome (186RNL). Phase 1 of the study will look to determine the maximum tolerated dose (MTD) of 186RNL in this patient population. Phase 2 of the study will use the recommended dose determined in Phase 1 to continue to look at overall response rate and progression-free survival following 186RNL treatment.",[201,29],"2025-07-10",{"date":399,"type":39},"2025-07-11",{"date":401,"type":19},"2025-09",{"date":403,"type":19},"2027-03",{"name":405,"class":172},"Plus Therapeutics",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":303,"enrollmentInfo":413,"targetDuration":4,"studyType":20,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":173},"100591046","local-targeted-therapy-with-alpha-emitter-225acac-dota-sp-tat-in-glioma-who-g3-g4-progression-100591046","NCT06975332","Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression","Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy in Glioma (WHO G3-G4) Progression","Inclusion Criteria:\n\n* age 18-80;\n* histologically confirmed diffuse glioma (CNS WHO G3-G4);\n* after standard treatment with biopsy or resection, radiotherapy and\u002For chemotherapy;\n* tumour progression as defined by RANO 2.0 on MRI (hyperintense lesion on MRI or increase of maximal transverse diameter of tumour or increase on volumetric measurement, local progression by continuity in proximity of 4 cm to primary lesion after resection, stable lesion progression on MRI \\>25% in time between two consecutive MRIs or any new lesion on MRI; to differentiate progression from pseudoprogression a biopsy may be needed, especially within 12 weeks from radiotherapy);\n* unifocal lesion;\n* after resection: tumour volume \\\u003C50 ml AND tumour tissue thickness on contrast-enhanced T1 MRI \\\u003C1 cm;\n* after biopsy: tumour median diameter \\\u003C2 cm;\n* functional state \\>70 according to Karnofsky's performance scale (KPS);\n* ability to give informed consent to participate in the study.\n\nExclusion criteria:\n\n* necessity of urgent surgery (e.g., sudden increase in intracranial pressure);\n* significant postoperative complications: e.g., Karnofsky's performance scale (KPS) \\\u003C70, wound infection, cerebrospinal fluid leak;\n* ventricular shunt leak \\>10% during a control patency test;\n* open\u002Fcommunicating resection cavity;\n* mass effect on CT scan or MRI with midline shift of more than 5 mm and\u002For nausea, vomiting, altered consciousness, or clinically significant papilledema;\n* catheter obstruction;\n* predicted life expectancy less than 3 months;\n* patients without preserved logical-verbal contact or uncooperative;\n* inability to provide informed, voluntary consent to participate in the study;\n* patients participating in another medical experiment;\n* patients who have taken any other investigational drug within 1 month of the first dose;\n* prior treatment with \\[225Ac\\]Ac-DOTA-SP;\n* breastfeeding or pregnancy;\n* severe diseases of other organs that, in the opinion of the Investigator, significantly increase the risk of the procedure.",{"count":414,"type":19},35,[59],"Brain tumors account for 1.35% of all cancers and cause 2.2% of cancer-related deaths. Gliomas are the most common type, comprising 40-90% of central nervous system tumors in different age groups. The incidence of malignant gliomas is approximately 0.5-2 per 100,000 people annually. Standard treatments include surgical resection, radiotherapy, and chemotherapy, yet overall survival remains low, typically 1-3 years post-diagnosis. The study highlights the pressing need for novel treatment strategies, particularly given the infiltrative nature of gliomas and the potential for targeted therapies using neuropeptides.\n\nThe aim of this study is to assess the efficacy and safety of local targeted therapy with \\[225Ac\\]Ac-DOTA-SP in recurrent glioblastoma.\n\nIt is an interventional study without a control group, initiated by the researcher. Patients included are aged 18-80 with recurrent WHO G3-G4 glioma post-first-line treatment, not requiring immediate surgery and meeting specific MRI progression criteria.\n\nPatients will receive a maximum of six cycles of \\[225Ac\\]Ac-DOTA-SP, involving pre-treatment assessments, local administration of the agent after ensuring catheter patency, and continuous monitoring. Blood tests and neurological evaluations will be performed regularly.\n\nOutcome will be assessed by measuring overall survival (OS) and progression-free survival (PFS). The study anticipates improvements in both OS and PFS when compared to current treatments, contributing to critical insights into targeted alpha therapy's effectiveness in glioblastoma.\n\nTreatment with \\[225Ac\\]Ac-DOTA-SP previously indicated few significant side effects, primarily transient issues like seizures. Patients will be closely monitored throughout the study to identify any adverse effects promptly.\n\nThe estimated study duration is three years, with biological material collected for histopathological and genetic analysis during surgical reoperation.\n\nData will be anonymized to protect patient confidentiality, stored securely, and made available only for the scope of the study.\n\nLed by Prof. Przemysław Kunert, the research team includes multiple co-investigators from neurosurgery and nuclear medicine departments.",[157,274,418,419],"Grade III Astrocytoma","Grade III Glioma",[421,422,423,424,425],"alpha emitter","glioblastoma recurrence","local therapy","225-Ac","high-grade glioma recurrence","2025-05-07",{"date":428,"type":39},"2025-05-16",{"date":430,"type":39},"2024-10-09",{"date":432,"type":19},"2027-09",{"name":434,"class":46},"Medical University of Warsaw",{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":20,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":47},"100566813","phase-1-a-phase-i-clinical-study-of-intratumoral-injection-gc001-in-patient-with-recurrent-or-progressive-gliomas-100566813","NCT06660056","A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas","A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of Oncolytic Vaccinia Virus GC001, Pharmacodynamics, Immunogenicity, and Antitumor Activity of the Virus in Patient With Recurrent or Progressive Gliomas","Inclusion Criteria:\n\nTo be eligible for participation in this study, individuals must meet the following criteria:\n\n1. Subjects must be able to comprehend and voluntarily sign written informed consent, which includes requirements related to study sample collection.\n2. Able to communicate with researchers; Understand and comply with the requirements of the study; Voluntary and able to complete study procedures and follow-up examinations.\n3. Be male or female patients aged 18 (including those with borderline age values).\n4. Patients with recurrent or progressive high-grade gliomas (WHO grade III-IV) that have been histopathologically or molecularly diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).\n5. At least 1 intracranial measurable lesion according to RANO criteria (well-defined enhancing lesion detected on MRI, diameter \\>10 mm).\n6. Patient's willingness to undergo surgical maneuvers related to placement of the Ommaya capsule.\n7. Karnofsky functional status ≥ 60.\n8. Be expected to survive for at least 3 months.\n9. No serious hematologic (no adjuncts such as EPO, G-CSF, or GM-CSF within 14 days prior to the first dose and no blood transfusions for at least 7 days), hepatic, or renal function abnormalities consistent with the following laboratory test results:\n\nsystems Laboratory test values routine blood test Absolute neutrophil count（ANC） ≥1.5×109\u002FL blood platelet（PLT） ≥100×109\u002FL hemoglobin（HGB） ≥90g\u002FL gallbladder serum creatinine（Cr） ≤1.5×Upper limit of normal range（ULN） creatinine clearance（Ccr）（To be calculated only if creatinine \\> 1.5 x ULN） ≥50mL\u002Fmin（Based on the Cockcroft-Gault formula） liver total bilirubin（TBIL） ≤1.5×ULN glutamic pyruvic transaminase（ALT） aspartate transaminase（AST） ≤2.5×ULN Alkaline phosphatase（ALP） ≤2.5×ULN coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN Partially activated thromboplastin time（APTT） ≤1.5×ULN 10.Male or female subjects of childbearing potential use effective contraception during treatment and for 6 months after dosing.\n\nExclusion Criteria:\n\n1. Inability to perform an MRI for any reason.\n2. focal point under the curtain.\n3. Prior history of encephalitis, multiple sclerosis, or other central nervous system infection (unless resolved).\n4. Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival \\> 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.\n5. Females of childbearing age who have a positive pregnancy test or are lactating.\n6. Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.\n7. Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.\n8. Patients who have previously received lysosomal virus, stem cell, or gene therapy products.\n9. Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).\n10. Those who have undergone antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration of the drug.\n11. Individuals who have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, Ommaya capsule etc.).\n12. Individuals who have been treated with systemic corticosteroids (at a dose equivalent to \\>10 mg dexamethasone \u002Fday) or other immunosuppressive medications within 28 days prior to the first dose, or who are currently taking antiviral medications (Mainly sensitive to poxviruses), enrollment is permitted under the following cases:\n\n    1. short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;\n    2. the use of topical topical or inhaled glucocorticoids is permitted;.\n13. A history of severe cardiovascular disease, including but not limited to:\n\n    1. A history of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree II-III AV block requiring clinical intervention;\n    2. Acute coronary syndrome, congestive heart failure, aortic coarctation, stroke, or other grade or greater cardiovascular event within 6 months prior to the first dose;\n    3. New York Heart Association (NYHA) \\> Class II heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; heart rate-corrected baseline QTcF intervals \\>450msec (men) and \\>470msec (women) using the Fridericia formula; any factor that increases the risk of QTc prolongation or the risk of cardiac arrhythmias, such as heart failure, hypokalemia , congenital long QT syndrome, family history of long QT syndrome, or use of any concomitant medication known to prolong the QT interval；\n    4. Clinically uncontrolled hypertension (blood pressure uncontrolled at \\\u003C 160 mmHg systolic and \\\u003C 100 mmHg diastolic after standard antihypertensive treatment).\n14. Recent Grade 3 or greater bleeding event within 6 months prior to the first use of study drug, or who have current \\> Grade 2 bleeding, or hemangioma\u002Fvascular malformation, or tumor stroke, tumor invasion of a blood vessel, or active peptic ulcer, or esophageal varices judged by the investigator to be at significant risk for bleeding.\n15. Those with a history of severe hemoptysis.\n16. Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.\n17. .Subjects with active or prior history of autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) or at high risk (e.g., patients who have undergone organ transplantation requiring immunosuppressive therapy) are not eligible for enrollment. However, enrollment is permitted for subjects with:\n\n    1. type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;\n    2. autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy；\n    3. Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded.\n18. Persons who are positive for human immunodeficiency virus (HIV) antibodies.\n19. Persons who have active hepatitis B (HBV)\u002Fhepatitis C (HCV) infection are not eligible for enrollment. However, subjects with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those who are HBsAg positive but have HBV DNA \\\u003C500 IU\u002Fml or below the lower limit of detection at the study center may also be enrolled. Subjects with primary liver cancer and HBV DNA \\\u003C1000 IU\u002Fml may be enrolled as well.\n20. Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.\n21. Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.\n22. Patients who, as determined by the investigator, are unsuitable for participation in the study.\n\n    \\-",{"count":414,"type":19},[94],"A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Recurrent or Progressive Gliomas .",[446],"High-grade Gliomas",[448,449,450,451],"Oncolytic virus","GC001","WR","high-grade gliomas","2025-03-11",{"date":454,"type":39},"2025-03-13",{"date":456,"type":39},"2024-10-08",{"date":458,"type":19},"2026-08-08",{"name":460,"class":46},"GONGCHU Biotechnology Co., Ltd",{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":20,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":488},"100572963","feasibility-of-aspirate-tissue-monitoring-in-neuro-oncological-surgery-100572963","NCT06740097","Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery","ATM GBM INT","Inclusion Criteria:\n\n* Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma\n* Patients aged 18 years old or older\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled",{"count":469,"type":19},50,[59],"Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. Surgeons use 5-aminolevulinic acid (5-ALA) drug-induced fluorescence to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are used to remove cancerous tissues, but so far the suction aspirate tissues have not been routinely used in tissue detection. This multicenter controlled clinical trial investigates the clinical performance and outcomes of a new method for detecting tumor from the suction aspirates in near-real time based on 5-ALA induced fluorescence. The feedback from the aspirate tissue monitor (ATM) is expected to improve the identification of tumors, leading to fewer reoperations and better treatment outcomes.",[29],[474,475,476,477,478],"aspirate tissue monitoring","high-grade glioma","5-ALA","fluorescence-guided surgery","neurosurgery","2024-12-13",{"date":481,"type":39},"2024-12-18",{"date":483,"type":39},"2024-09-30",{"date":485,"type":19},"2028-09-01",{"name":487,"class":46},"Kuopio University Hospital",3]