[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-tumor-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-tumor-recurrent":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,55,88,126,152,190,217,254],{"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":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"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",false,"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.","ALL","3 Years","25 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma","High Grade Gliomas","Medulloblastoma Recurrent","Ependymoma Recurrent","Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS","Brain Tumor Recurrent",[34,35,36,37,38,39,40,41,42],"Focused Ultrasound","Pediatrics","Diffuse Midline Glioma","DMG","Diffuse Intrinsic Pontine Glioma","DIPG","High Grade Glioma","HGG","Nivolumab","NOT_YET_RECRUITING","2026-06-17",{"date":46,"type":47},"2026-06-24","ACTUAL",{"date":49,"type":21},"2026-06-01",{"date":51,"type":21},"2030-12",{"name":53,"class":54},"Children's National Research Institute","OTHER",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100567324","phase-1-chronic-ced-of-tpt-for-recurrent-malignant-glioma-100567324","NCT06666712","Chronic CED of TPT for Recurrent Malignant Glioma","Chronic Convection Enhanced Delivery of Topotecan for Recurrent Malignant Glioma","TPT CED rHGG","Inclusion Criteria:\n\n1. Patients must have recurrent malignant glioma with a history of WHO grade 3-4 IDH-mutant status and evidence of radiographic progression and suspicion of histopathological recurrence. Stereotactic biopsies will be performed to assess the presence of active tumor by frozen section prior to initiating treatment. Patients with a history of WHO grade 2 recurrent glioma, IDH-Mutant, who now demonstrate high-grade features of IDH-mutant WHO grade 3-4 will also be included.\n2. Patients with recurrent malignant glioma, IDH-mutant, who have failed standard of care treatment are eligible.\n3. An MRI scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect. Tumors must be less than 32 cc in total volume as assessed by the principal investigator based on pre-enrollment MRI. The lesion must be stereotactically accessible.\n4. Karnofsky performance score must be greater than or equal to 70.\n5. Men and women of childbearing potential must practice birth control. Women of childbearing potential must have a urine pregnancy test within 7 days of study entry. In accordance with topotecan administration guidelines, women must practice birth control for at least 1 month following chemotherapy infusion. Men must practice birth control for at least four months following termination of chemotherapy infusion.\n6. Patients or appropriate legally authorized representatives must possess the ability to give Informed Consent.\n7. Patients must be willing to and medically capable of undergoing the surgical operation.\n8. Patients must be at least 18 years old.\n9. Patients must not have known abnormal organ and marrow function as defined below 14 days or fewer from registration:\n\n   * Leukocytes: ≥3,000\u002FmcL\n   * Absolute neutrophil count : ≥1,500\u002FmcL\n   * Platelets: ≥100,000\u002FmcL\n   * Total bilirubin: within normal institutional limits\n   * AST(SGOT)\u002FALT(SGPT): ≤2.5 × institutional upper limit of normal\n   * Creatinine: within normal institutional limits OR\n   * Creatinine clearance: ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n\nExclusion Criteria:\n\n1. Patients with diffuse subependymal or CSF disease.\n2. Patients with tumors involving the cerebellum or both cerebral hemispheres.\n3. Patients with an active infection requiring treatment or having an unexplained febrile illness.\n4. Patients who are known HIV, Hepatitis B or Hepatitis C positive. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Topotecan. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. HIV, Hepatitis B and Hepatitis C testing is not required for patients not known to have these infections.\n5. Patients with systemic diseases which may be associated with unacceptable anesthetic\u002Foperative risk.\n6. Patients who have previously received systemic topotecan for their tumor.\n7. Patients who are not able to receive MRI or PET scans.\n8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan, other topoisomerase inhibitors or gadolinium compounds.\n9. Patients who are currently receiving treatment with agents that are metabolized solely through cytochrome P450 (CYP) 3A4\u002F5 (CYP3A4\u002F5) and have a narrow therapeutic index or are strong CYP2C8 inhibitors. Patients who are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates are also ineligible. Caution should be used in patients taking other CYP2C8 - or CYP3A4\u002F5-interacting agents as they may increase the serum concentrations of topotecan. If previously on such agents, the patient must discontinue them for at least two weeks prior to study treatment.\n10. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing active infection, systemic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Women of childbearing potential who fail to demonstrate a negative pregnancy test 7 or fewer days from registration.\n12. Women who are breast-feeding.","18 Years",{"count":65,"type":21},6,[24],"The primary goal of this study is to establish the safety of chronic Convection Enhanced Delivery (CED) of the chemotherapeutic drug Topotecan for patients with recurrent malignant glioma that harbors the Isocitrate Dehydrogenase mutation (IDH-mut). The secondary goal of the study is to study drug distribution and assess the tumor response to prolonged continuous CED of Topotecan.\n\nConvection Enhanced Delivery is a novel method of drug delivery that allows administration of a drug directly to the brain. In CED, a drug pump is placed under the skin in the chest or abdominal region. The pump is connected to a catheter that is tunneled underneath the skin to the brain. The tip of the catheter then infuses Topotecan directly onto the brain tumor. There will be a total of four treatment infusions over the course of 23-29 days, with a 5-7-day rest period between each infusion. Throughout this period, patients' health will be monitored through imaging, blood draws, and regular exams. At the end of the treatment period, the pump will be removed, followed by resection of the tumor. Patients will be followed for the duration of their lives.\n\nThis is the investigator's second clinical trial studying CED of TPT in recurrent glioma. In the prior Phase 1b trial, chronic pulsatile CED safely and effectively delivered Topotecan to patients with IDH mutant recurrent Glioblastoma (WHO grade 4).",[69,70,71],"Brain Tumor, Recurrent","Malignant Glioma (WHO Grade III or IV)","IDH1\u002FIDH2 Mutation",[73,74,75,76,77],"Brain Tumors","topotecan","Convection-Enhanced Delivery (CED)","Glioma","IDH Mutation","RECRUITING","2026-06-12",{"date":81,"type":47},"2026-06-15",{"date":79,"type":47},{"date":84,"type":21},"2028-01",{"name":86,"class":54},"Jeffrey N. Bruce",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100487639","phase-2-aristocrat-blinded-trial-of-temozolomide---cannabinoids-100487639","NCT05629702","ARISTOCRAT: Blinded Trial of Temozolomide +\u002F- Cannabinoids","A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma","ARISTOCRAT","Inclusion Criteria:\n\n* Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required).\n* First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence and not pseudo-progression. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment.\n* Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in consultation with the ARISTOCRAT Trial Office) with concomitant and adjuvant TMZ.\n\n  * A minimum of 3 cycles of adjuvant TMZ must have been received.\n  * A minimum of Stable Disease (SD) (or Partial Response (PR)\u002FComplete Response (CR)) at the end of first-line treatment (measured by Response Assessment for Neuro-Oncology (RANO) criteria).\n* ≥3 months since day 28 of the last cycle of TMZ.\n* Karnofsky Performance Status ≥60.\n* Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation:\n\n  * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n  * Platelet count ≥100 x 109\u002FL\n  * Serum creatinine clearance (measured or calculated (using local standard practice)) \\>30ml\u002Fmin\n  * Total serum bilirubin ≤1.5 x upper limit of normal (ULN)\n  * Liver transaminases \\\u003C2.5 x ULN\n* If surgery has been performed for first recurrence, then the wound must be adequately healed and there must be residual enhancing disease on MRI within 21 days of surgery or new enhancement at later follow up deemed suitable for systemic treatment.\n* Recovered from previous treatment side-effects ≤ Grade 2.\n* If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids.\n* Willing and able to provide trial-specific informed consent.\n* Willing and able to comply with trial requirements.\n* Age ≥16.\n* Able to start treatment within 28 days of randomisation.\n\nExclusion Criteria:\n\n* Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).\n* Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year.\n* Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.\n* Prior treatment, apart from debulking surgery, for first recurrence of GBM.\n* Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.\n* Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition.\n* Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment.\n* Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and\u002For unwilling to abstain for the duration of the trial.\n* Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment.\n\n  o Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation.\n* Men who are sexually active and unwilling\u002Funable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment.\n* Contra-indication to MRI or gadolinium.\n* Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.\n* Known hypersensitivity to cannabinoids or excipients of the IMP.\n* Known history of current or prior alcohol or drug dependence.\n* Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection.\n* Has received a live vaccine within 28 days prior to randomisation.\n* Unable to administer oromucosal medication due to mucosal lesions or other issues.\n* Participation in another therapeutic clinical trial whilst taking part in this trial.\n* Any psychological, familial, sociological or geographical condition hampering protocol compliance.","16 Years",{"count":98,"type":21},120,[100],"PHASE2","ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).",[103,104,105,69],"Glioblastoma","Brain Tumor","Cannabis",[107,108,109,110,111,112,113,114,115],"cannabinoid","GBM","temozolomide","sativex","nabiximols","cannabis","glioblastoma","brain","recurrent","2026-04-29",{"date":118,"type":47},"2026-05-05",{"date":120,"type":47},"2023-02-03",{"date":122,"type":21},"2027-04",{"name":124,"class":54},"University of Birmingham",22,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":87},"100270475","phase-2-super-selective-intra-arterial-repeated-infusion-of-cetuximab-erbitux-with-reirradiation-for-treatment-of-relapsedrefractory-gbm-aa-and-aoa-100270475","NCT02800486","Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed\u002FRefractory GBM, AA, and AOA","Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed\u002FRefractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age\n* Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)\n* Patients with pathology confirmed histologic EGFR overexpression\n* Patients must have at least one confirmed and evaluable tumor site.∗\n\n  \\*A confirmed tumor site is one in which is biopsy-proven\n* Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.\n* No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol\n* Patients must have adequate hematologic reserve with WBC≥3000\u002Fmm3, absolute neutrophils ≥1500\u002Fmm3 and platelets ≥100,000\u002F mm3. Patients who are on Coumadin must have a platelet count of ≥150,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5X the institutional upper limit of normal (IUNL); AST or ALT\\\u003C2.5X IUNL and creatinine\\\u003C1.5X IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Women of childbearing potential and fertile men will be informed of the potential unknown risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period\n* Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring\n* Patients with radiological evidence of leptomeningeal disease\n* Patients with history of allergic reaction to CTX\n* Patients who completed chemo\u002FRT less than 6 months prior to enrollment\n* Patients who have not failed standard Stupp protocol",{"count":134,"type":21},37,[100],"Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg\u002Fm2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.",[103,138,139,76,140,141,104,69,142],"Anaplastic Astrocytoma","Anaplastic Oligoastrocytoma","Brain Neoplasm","Brain Cancer","Brain Neoplasm, Malignant","2026-04-08",{"date":145,"type":47},"2026-04-13",{"date":147,"type":47},"2016-05",{"date":149,"type":21},"2036-05",{"name":151,"class":54},"Northwell Health",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":170,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":189},"100554275","phase-3-a-prospective-pivotal-study-to-evaluate-the-efficacy-and-safety-of-avastin-bevacizumab-bev-with-or-without-microbubble-mediated-focused-ultrasound-fus-mb-using-navifus-system-in-recurrent-glioblastoma-multiforme-patients-100554275","NCT06496971","A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients","A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of study enrollment.\n2. Body mass index (BMI) ≥ 17 kg\u002Fm2.\n3. Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.\n4. Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.\n5. Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3.\n6. If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids for at least 1 week prior to the planned first treatment.\n7. At the time of study enrollment, the minimum interval since the last event:\n\n   * 4 weeks out from invasive procedures (e.g., open biopsy, surgical resection, significant traumatic injury, or any other major surgery involving entry into a body cavity) and the patient must have recovered from the effects of surgery\n   * 1 week out from minor surgical procedures or core biopsies\n8. Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:\n\n   * 4 weeks out from any investigational drug or device\n   * 4 weeks out from chemotherapy\n   * 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))\n   * 12 weeks out from completion of radiotherapy\n9. Patients should have a life expectancy ≥ 12 weeks.\n10. Patients must have Karnofsky Performance Status (KPS) ≥ 70.\n11. Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:\n\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Platelets ≥ 100,000\u002Fmm3\n    * Neutrophils ≥ 1,500\u002Fmm3\n    * Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n    * Urine protein creatinine ratio (UPCR) \\\u003C 1 or urine dipstick for proteinuria ≤ 2+\n    * Alanine aminotransferase (ALT) \\\u003C 3 × ULN\n    * Aspartate aminotransferase (AST) \\\u003C 3 × ULN\n    * Total bilirubin (TBL) \\\u003C 2 × ULN\n    * Prothrombin time ≤ 1.5 x ULN\n    * International Normalized Ratio (INR) \\\u003C 1.5 These tests must be conducted within 2 weeks prior to the planned first treatment.\n12. The central of FUS exposure region is located with a minimum distance of at least 30 mm beneath the skull bone.\n13. Females of childbearing potential must have a negative pregnancy test documented within 2 weeks prior to first treatment. Females of childbearing potential and male patients with partners of childbearing potential must agree to adhere to an acceptable method of contraception (as outlined below) from prior to the first study treatment until at least 6 months after the completion of last treatment. Standard acceptable methods of contraception include the use of highly effective methods such as hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, or abstinence from sexual activity.\n14. Patients are able and willing to have peripheral intravenous (IV) line placement of Bevacizumab and are able to have hair shaved (either whole head or in the region where the coupling membrane will touch) prior to FUS treatment if assigned to treatment group.\n15. Patients or their legal representatives are able to provide written informed consent for participation in the trial and patients are willing to comply the procedures (i.e., study-related assessments), instructions, and restrictions outlined in this study in the duration of the study. Informed consent should also be given for biological materials and diagnostic imaging to be stored and used for future research on brain tumors.\n\nExclusion Criteria:\n\n1. Patients who have radiographic evidence of multifocal enhancing tumors.\n2. Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.\n3. Patients who have previously received Carmustine wafers implantation during re-operation.\n4. Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.\n5. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment\n   * Unstable angina pectoris\n   * Medical history of myocardial infarction within 6 months prior to study enrollment\n   * Cardiac shunt\n6. Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment.\n7. Patients with implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator (RNS), deep brain stimulation (DBS), or other electronic devices implanted in the brain. Patients with contraindications for MRI as judged by Investigator, including non-MRI compatible metallic implant(s).\n8. Patients with inadequately controlled hypertension, defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg while on medication, within 2 weeks prior to first treatment.\n9. Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:\n\n   * Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).\n   * History of pulmonary haemorrhage\u002Fhaemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment\n   * Arterial or venous thrombosis (e.g., pulmonary embolism) within 3 months prior to study enrollment\n10. Patients with unstable pulmonary disease or chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study enrollment.\n11. Patients who have psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Known HIV-positive patient, however, that HIV testing is not required for entry into this study.\n13. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment.\n14. History or evidence of active gastroduodenal ulcer, gastrointestinal perforations\u002Ffistula, or intra-abdominal abscess within 6 months prior to study enrollment.\n15. Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment.\n16. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, SonoVue®, Bevacizumab, or any of their components.\n17. Pregnant (positive pregnancy test) or breast-feeding women.\n18. Use of any recreational drugs or history of drug addiction.\n19. Other severe concurrent and\u002For uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled epilepsy, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.\n20. Any other condition that, in the Investigator's discretion, might increase the risk to the patients or compromise the evaluation of the clinical trial endpoints.","80 Years",{"count":161,"type":21},32,[163],"PHASE3","This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.",[166,103,167,76,104,69,168,169],"Glioblastoma Multiforme","Glioblastoma Multiforme, Adult","Neoplasms","Neoplasms, Nerve Tissue",[171,172,34,173,174,175,176,177,178],"NaviFUS System","Blood-Brain Barrier Opening","FUS","Low-Intensity Focused Ultrasound","LIFU","Bevacizumab","BEV","Avastin","2026-04-06",{"date":181,"type":47},"2026-04-09",{"date":183,"type":47},"2024-11-08",{"date":185,"type":21},"2027-03-31",{"name":187,"class":188},"NaviFUS Corporation","INDUSTRY",2,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":197,"targetDuration":199,"studyType":200,"phases":4,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100395308","registry-of-patients-with-brain-tumors-treated-with-start-gammatiles-100395308","NCT04427384","Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)","A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms","Inclusion Criteria:\n\n1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.\n2. Willing and able to provide informed consent and to participate in all evaluations.\n\nExclusion Criteria:\n\n1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.\n2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and\u002For interfere with follow ups.\n3. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.",{"count":198,"type":21},600,"5 Years","OBSERVATIONAL","The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.",[69,104,203,204,205,206],"Brain Tumor, Primary","Brain Tumor - Metastatic","Brain Tumor, Adult: Glioblastoma","Brain Tumor, Adult Meningioma","2026-02-11",{"date":209,"type":47},"2026-02-13",{"date":211,"type":47},"2020-09-11",{"date":213,"type":21},"2028-12-31",{"name":215,"class":188},"GT Medical Technologies, Inc.",54,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":242,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":189},"100622970","phase-1-b7-h3cd28zcart-in-cns-neoplasms-100622970","NCT07390539","B7-H3.CD28Z.CART in CNS Neoplasms","A Phase 1\u002F1b Study of Autologous b7-h3 Chimeric Antigen Receptor t Cells (b7-h3.cd28z.Cart) in Children and Young Adults With Recurrent or Progressive Cns Neoplasms Expressing b7-h3 Target","Pre-screening Inclusion Criteria:\n\n* Participants must have histologically and\u002For molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent\u002Fprogressive following standard of care treatment.\n\n  --Eligible CNS embryonal tumor types include:\n  * Medulloblastoma\n  * Atypical Teratoid Rhabdoid Tumor (ATRT)\n  * Embryonal Tumor with Multilayered Rosettes (ETMR) Pineoblastoma\n  * Other CNS embryonal tumor types, at the discretion of the study chair (or designee)\n* Participants must have adequate pre-trial tumor material available to determine B7- H3 expression status. Tumor tissue from the most recent resection or biopsy of recurrent disease is preferred. If unavailable, tumor tissue from prior recurrences or from time of initial diagnosis is acceptable. Biopsies will not be performed for participation in this research trial or for research purposes.\n* Pre-screening IHC Consent: All participants ≥ 18 years of age must be able to give informed consent. For participants \\\u003C18 years of age, their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric participants will be included in age-appropriate discussion and written assent will be obtained for those ≥10 years of age, where appropriate. If a minor becomes of age during participation of this study, they will be asked to reconsent as an adult.\n\nInclusion Criteria:\n\n* Participants must have histologically and\u002For molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent\u002Fprogressive following standard of care treatment.\n\n  --Eligible CNS embryonal tumor types include:\n  * Medulloblastoma\n  * Atypical Teratoid Rhabdoid Tumor (ATRT)\n  * Embryonal Tumor with Multilayered Rosettes (ETMR)\n  * Pineoblastoma\n  * Other CNS embryonal tumor types, at the discretion of the study chair (or designee)\n* B7-H3 expression: Demonstration of B7-H3 expression with H score greater than 100 by immunohistochemistry (IHC) is required.\n* Age: greater than or equal to two (2) years of age and less than or equal to 21 years of age. The first participant treated at each dose level within each stratum (Standard Risk and High Risk) will be ≥ 6 years of age when feasible.\n* Disease status: Participants must have evaluable disease in the central nervous system to be eligible. Evaluable disease includes either measurable OR non-measurable disease, defined as follows:\n\n  --Measurable disease (contrast-enhancing or non-enhancing tumor)\n  * Clearly defined lesional margins with two perpendicular diameters of at least 10mm, OR\n  * At least two times (in both perpendicular diameters) the MRI slice thickness, plus the interslice gap\n\n    --Non-measurable disease (tumor that is too small to be accurately measured)\n  * Lesion that is measurable in only one perpendicular dimension, OR\n  * Lesion that is less than 10mm in at least one perpendicular dimension, OR\n  * Lesion that is less than two times the MRI slice thickness, plus the interslice gap\n  * Note: Leptomeningeal (LM) disease is considered non-measurable but evaluable.\n* Performance status: Karnofsky performance status ≥60% for participants ≥16 years of age and Lansky performance status ≥60% for participants \\\u003C16 years of age (see APPENDIX A PERFORMANCE STATUS CRITERIA). NOTE: Participants with neurologic deficits must have a stable neurologic exam for seven (7) days prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Life expectancy of greater than 12 weeks\n* Prior therapy: Participants must have received prior standard of care therapy, including maximal safe surgical resection, radiation therapy and\u002For standard chemotherapy, and is recovered from all acute treatment-related toxicities (defined as ≤ Grade 1 or stable) from all prior therapy before entering this study There is no upper limit to the number of prior therapies allowed, but must have received all standard curative options for their tumor type.\n* Participants must meet the following washouts prior to enrollment:\n\n  * Radiation therapy - Participants must have had their last fraction of:\n\n    ---Craniospinal irradiation, whole brain radiation therapy, or radiation therapy to \\>50% of the pelvis or spine \\>28 days prior to enrollment\n\n    ---Focal irradiation (small port) \\>14 days prior to enrollment\n  * At least 14 days since any prior cytotoxic chemotherapy\n  * At least 7 days since any biologic antineoplastics, tyrosine kinase inhibitor, targeted agent\n  * At least 21 days or 5 half-lives (whichever is shorter) since any investigational antineoplastic or disease-directed agent (but at least 28 days from prior investigational antineoplastic vaccine therapy)\n  * At least 21 days since any monoclonal antibody therapy\n  * At least 90 days since any systemic inhibitor\u002Fstimulatory immune checkpoint therapy\n  * At least 28 days from prior autologous stem cell transplantation, with no ongoing toxicities\n  * At least 14 days after peg-filgrastim and 7 days for hematopoietic growth factor support\n* Steroid use: Must not require concurrent systemic steroid therapy, although physiologic corticosteroid replacement therapy for management of pituitary\u002Fadrenal insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed. Use of topical, ocular, intranasal, or inhaled corticosteroids are permitted per PI\n\ndiscretion.\n\n* Participants must have adequate organ function, as defined below\n\n  --Adequate bone marrow function\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥ 1000 cells\u002FuL\n  * Absolute lymphocyte count (ALC) ≥ 150 cells\u002FuL\n  * Platelets ≥100,000\u002FuL (unsupported, defined as no platelet transfusion within 4 days)\n* Adequate renal function defined as creatinine within normal limits for age OR creatinine clearance (as estimated by Cockcroft Gault Equation for participants ≥ 18yo and Bedside Schwartz for participants \\\u003C18yo) ≥70mL\u002Fmin\n\n  * Maximum Serum Creatinine mg\u002FDL ---6 months to 1 year Male 0.5 Female 0.5 ---1 to \\\u003C 2 years Male 0.6 Female 0.6 ---2 to \\\u003C 6 years Male 0.8 Female 0.8\n\n    * 6 to \\\u003C 10 years Male 1 Female 1\n    * 10 to \\\u003C 13 years Male 1.2 Female 1.2\n    * 13 years to \\\u003C 16 years Male 1.5 Female 1.4\n\n      * 16 years Male 1.7 Female 1.4\n* Adequate hepatic function\n\n  * Serum ALT\u002FAST ≤3.0 upper limit of normal (ULN)\n  * Total bilirubin ≤1.5mg\u002FdL, except in subjects with confirmed Gilbert's syndrome\n* Adequate cardiac function\n\n  --Ejection fraction ≥50% or fractional shortening ≥28%, measured by echocardiography\n* Adequate pulmonary function\n\n  * No evidence of dyspnea at rest\n  * Pulse oximetry \\>92% whilst breathing room air\n* Adequate neurologic function\n\n  * Participants with seizure disorders on anticonvulsants may be enrolled if seizures are well controlled (no seizure activity within 7 days prior to enrollment)\n  * Nervous system disorders (CTCAE v6.0) resulting from prior therapy must be ≤ Grade 2, with the exception of decreased tendon reflex (DTR; any Grade eligible). Participants with neurological deficits should be stable for a minimum of 7 days prior to enrollment. (A baseline detailed neurological exam should clearly document the neurological status of the participant prior at enrollment).\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization are not considered to be of childbearing potential)\n* Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for one year after receiving the preparative lymphodepletion regimen, or for as long as B7- H3.CD28Z.CART cells are detectable in peripheral blood or CSF, whichever is later.\n* Participant or parent of participant or legally recognized representative must be able to sign a written informed consent document. Pediatric participants will be included in age-appropriate discussion and written assent will be obtained for those ≥10 years of age, where appropriate.\n\nExclusion Criteria:\n\n* Participants with bulky tumor are ineligible. Bulky tumor is defined as:\n\n  * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR sequence\n  * Tumor with evidence of clinically significant midline shift or uncal herniation\n  * Tumor that, in opinion of the site investigator, shows significant mass effect in either the brain or spine\n* Participants with clinical or radiological evidence of brain herniation.\n* Participants who have received other B7-H3 targeted cellular therapies. Other prior cellular therapies are eligible, including immune checkpoint inhibition and vaccine therapy. These prior therapies should be discussed with the study chair (or designee) prior to participant enrollment.\n* Concurrent illness\n\n  * Participants with any prior immunodeficiency or history of autoimmune disease requiring systemic steroids\u002F immunosuppressive medication\u002F disease-modifying agents within the last two (2) years.\n  * Uncontrolled (Grade 3) bacterial, viral, fungal, or other infection.\n  * Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n  * Evidence of severe or uncontrolled systemic disease (e.g. Grade 3 significant cardiac, pulmonary, hepatic, renal or other organ dysfunction) that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements.\n  * Known sensitivity or allergy to any of the agents\u002Freagents used in this study (i.e. DSMO, cyclophosphamide, fludarabine)\n  * History of severe hypersensitivity reaction to compounds of similar chemical or biologic compositions to any agent used in the study or in the manufacturing of cells.\n* Concomitant medications\n\n  * Current systemic corticosteroid therapy\n  * Note, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency will be allowed.\n  * Participants who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n  * Participants who have received the last vaccination of a live vaccine ≤ 30 days prior to the start of treatment are ineligible.\n  * Ongoing use of dietary supplements, alternative therapies or extreme diets, or any medication not approved by the study chair (or designee).\n* Any other condition which in the principal investigator's opinion makes the individual clinically unsuitable to participate in this trial, or which would jeopardize compliance with the protocol, or would make it difficult to interpret adverse events or study data.","2 Years","21 Years",{"count":227,"type":21},70,[24],"The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent\u002Frecurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy.\n\nThe names of the study investigational therapies involved in this study are:\n\n* Fludarabine (a type of chemotherapy)\n* Cyclophosphamide (a type of chemotherapy)\n* B7-H3 CAR T cells (a type of cellular therapy)",[231,104,69,232,233,234,235,236,29,237,238,239,240,241],"Central Nervous System Neoplasms","Brain Tumor, Pediatric","Brain Tumor Adult","Medulloblastoma","Medulloblastoma, Childhood","Medulloblastoma, Adult","Ependymoma","Atypical Teratoid\u002FRhabdoid Tumor","Embryonal Tumor With Multilayered Rosettes","Pineoblastoma","Leptomeningeal Disease",[231,104,232,243,32,234,235,236,29,237,238,244,240,241],"Brain Tumor, Adult","Embryonal Tumor with Multilayered Rosettes","2026-01-28",{"date":247,"type":47},"2026-02-05",{"date":249,"type":21},"2026-07",{"date":251,"type":21},"2032-08-31",{"name":253,"class":54},"Robbie Majzner",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":87},"100344340","early-phase-1-azoles-targeting-recurrent-high-grade-gliomas-100344340","NCT03763396","Azoles Targeting Recurrent High Grade Gliomas","A Phase 0 Clinical Trial of Two Candidate Azoles (Ketoconazole and Posaconazole) for Patients With Recurrent High Grade Glioma","Inclusion Criteria:\n\n* Age ≥18 years\n* Evidence of recurrent HGG that in the opinion of the treating team does not represent pseudoprogression and would require surgical resection\n* Karnofsky Performance Score (KPS) ≥ 60%\n* ECOG ≤ 2\n* Life expectancy greater than 12 weeks\n* Adequate liver function defined as ALT, AST, ALP, GGT, bilirubin within 1.5x institutional upper limit of normal\n* Potassium, calcium, and magnesium within normal limits (PCZ cohort)\n* Adequate renal function defined as eGFR levels within 1.5x the institutional upper limit of normal (only for KCZ cohort)\n* Ability to swallow medication\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation.\n* Ability to understand and willingness to sign a written informed consent document\n* Be able to comply with treatment plan, study procedures and follow-up examinations\n\nExclusion Criteria:\n\n* 1\\. Patients may not be receiving any other investigational agents while on study\n* Patients who have known allergy to KCZ, PCZ, or other azoles\n* Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous azole class drugs for a parasitic infection\n* Patients with a history of acute or chronic hepatitis\n* Patients with liver enzymes (ALT, AST, ALP, GGT, Bilirubin) \\>1.5x above normal range for the laboratory performing the test\n* ECG with QT \\> 450 msec (PCZ cohort)\n* Patients taking drugs known to prolong the QT interval (PCZ cohort)\n* Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting KCZ therapy\n* Patients who have taken any azoles within the last 3 months\n* Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.) and who cannot be switched to alternative medications such as keppra (levetiracetam)\n* Uncontrolled intercurrent illness such as chronic hepatitis, acute hepatitis, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements\n* Patients with a history of Addison's disease or other forms of adrenal insufficiency\n* Patient with little or no stomach acid production (achlorhydria) are excluded from the KCZ cohort\n* Pregnant and breast feeding women\n* Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results.\n* Patients who are not available for follow-up assessments or unable to comply with study requirements.\n* Patients who are currently taking medications that induce the metabolism of KCZ or PCZ, such as isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), St. John's wort, among others (see section 5.3 for full details).\n* Patients who are currently taking medications for which the metabolism may be affected by KCZ or PCZ, which include but are not limited to: benzodiazepines (such as alprazolam, midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), some drugs used to treat seizures (such as carbamazepine, phenytoin), some statin drugs (such as atorvastatin, lovastatin, simvastatin)",{"count":20,"type":21},[263],"EARLY_PHASE1","High-grade gliomas are the most common and aggressive type of brain cancer. Scientists don't fully understand how they grow and spread, and treatments haven't improved much in recent years. However, it's been discovered that these cancers rely heavily on using glucose to maintain their cancerous traits. In lab tests, drugs from the azole class, which target a key step in glucose metabolism, have shown promise in reducing tumor growth in these cancers. Researchers now want to test two of these drugs, ketoconazole and posaconazole, in patients with recurring high-grade gliomas. A small group of these patients will receive either one or several doses of these drugs before undergoing surgery. During the surgery, doctors will measure how much of the drug is present in the brain. They will also study how the drug affects the tumor, particularly its ability to process glucose. This research aims to provide initial insights into how these drugs work in patients with this type of brain cancer, which could guide future research and treatment strategies.",[69,266,267],"Cancer, Advanced","Glioma of Brain",[269],"recurrent high grade glioma, posaconazole, ketoconazole, hexokinase 2 (HK2)","2024-03-07",{"date":272,"type":47},"2024-03-08",{"date":274,"type":21},"2024-06-01",{"date":276,"type":21},"2027-06",{"name":278,"class":54},"University Health Network, Toronto"]