[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gbm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gbm":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,63,76,106,129,149,186,208,235,258,277,301,328,352,376,400,435,463,485,509,536,558],{"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":26,"conditions":27,"keywords":43,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053479","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100053479",false,"NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo craniotomy for brain biopsy and\u002For resection\n\n  --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able to achieve a gross total resection of tumor will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","ALL","18 Years","99 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioma","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","High Grade Glioma","Glioma, Malignant","Brain Cancer",[28,35,44,45,46,47,48,49,42],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":21},"2026-07-16",{"date":58,"type":21},"2032-12-31",{"name":60,"class":61},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":64,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":26,"conditions":67,"keywords":68,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":75,"locationsCount":62},"100624942",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],[28,35,44,45,46,47,48,49,42],"2026-07-01",{"date":71,"type":54},"2026-07-02",{"date":73,"type":21},"2026-07-07",{"date":58,"type":21},{"name":60,"class":61},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100508572","phase-3-sonocloud-9-in-association-with-carboplatin-versus-standard-of-care-chemotherapies-ccnu-or-tmz-in-recurrent-gbm-100508572","NCT05902169","Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM","A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.","SONOBIRD","Inclusion Criteria:\n\n1. Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.\n2. Patient must have received prior first line therapy that must have contained both:\n\n   1. Prior surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy\u002Ffraction, \\>56 Gy\\\u003C66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen)\n   2. One line of maintenance chemotherapy and\u002For immune- or biological therapy, (with or without Tumor-Treating Fields)\n3. First, unequivocal disease progression with\n\n   1. measurable tumor (\\>100 mm2 or 1 cm3, based on RANO criteria) documented (e.g., increase of 25% in tumor diameter) on MRI performed within 14 days of inclusion and,\n   2. interval of a minimum of 12 weeks since the completion of prior radiotherapy, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling\n4. Patient is candidate for craniotomy and at least 50% resection of enhancing region\n5. Maximal enhancing tumor diameter prior to inclusion ≤ 5 cm on T1w. (In case of planned lobectomy, post operative peritumoral brain or residual size ≤5 cm)\n6. WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70)\n7. Age ≥ 18 years\n8. Participant must be recovered from acute toxic effects (\\\u003Cgrade 2) of all prior anticancer therapy. Interval since last therapy to presumed date of surgery of at least:\n\n   1. ≥ 4 weeks or 5 half-lives (whichever is shorter) for\n\n      * Cytotoxic\n      * Other small chemical entity (e.g., targeted therapy)\n      * For biologics (e.g., antibodies, except bevacizumab)\n   2. ≥ 6 weeks of prior bevacizumab\n9. Adequate hematologic, hepatic, and renal laboratory values within 14 days of inclusion i.e.:\n\n   1. Hemoglobin ≥ 10 g\u002FdL, platelets ≥ 100,000\u002Fmm3, neutrophils ≥ 1500\u002Fmm3.\n   2. Liver function test with ≤ grade 1 alterations, except if due to antiepileptic drug therapy or isolated increased bilirubin due to Gilbert syndrome\n   3. Estimated glomerular filtration rate (eGFR) of at least 60 mL\u002Fmin\u002F1.73 m2 using Cockcroft Gault formula\n10. Patient able to understand clinical trial information and willing to provide signed and informed consent\n11. Patient of childbearing potential must have a negative pregnancy test within 14 days of inclusion and must agree to use a medically-acceptable method of birth control during the treatment period and, if randomized in the experimental arm, for at least 1 month after the last cycle of carboplatin\n12. A male patient must agree to use condoms during the treatment period and, if randomized in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from donating sperm during this period.\n13. Patient must be a beneficiary of a health plan that covers routine patient care costs. Patient must be a beneficiary of or affiliated with a social security scheme (according to country-specific requirements)\n\nNon-Inclusion Criteria:\n\n1. Multifocal enhancing tumor on T1w (unless all localized in a 5 cm diameter area)\n2. Posterior fossa tumor\n3. Known BRAF\u002F NTKR mutated patients\n4. Patient at risk of surgery site infection (e.g., 2 or more previous craniotomies\u002Fneurosurgery within the last 3 months, poor skin condition, and\u002For previously infected surgical field, or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)\n5. Patient treated at high, stable -or average- dose of corticosteroids (≥ 6 mg\u002Fday dexamethasone or equivalent) in the 7 days prior to inclusion. Patients on dexamethasone for reasons other than mass effect may still be enrolled.\n6. Contra-indication to carboplatin, CCNU or TMZ\n7. Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in ultrasound resonator\n8. Patient has received bevacizumab for other reasons (such as tumor progression) than treating edema\n9. Peripheral neuropathy or neuropathy ≥ grade 2\n10. Uncontrolled epilepsy or evidence of intracranial pressure\n11. Patient with known intracranial aneurism or having presented intra-tumor significant spontaneous hemorrhage\n12. Patient with unremovable coils, clips, shunts, intravascular stents, and\u002For wafer, or reservoirs\n13. Patient with medical need to be on continued anti-platelet aggregation therapy and\u002For anticoagulation. Patients for whom anticoagulation\u002Fplatelet aggregation can be temporarily interrupted may be eligible after discussion and prior authorization by the sponsor.\n14. Patient receiving enzyme-inducing antiepileptic drugs (namely phenytoin, carbamazepine and derivatives, phenobarbital), unless switched on another antiepileptic regimen\n15. History of other malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix\n16. Patient with known or suspected active or chronic infections\n17. Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \\> 90 mm Hg), uncontrolled systemic hypertension, or acute respiratory distress syndrome\n18. Known sensitivity\u002Fallergy to gadolinium, or other intravascular contrast agents\n19. Patient with impaired thermo-regulation or temperature sensation\n20. Pregnant, or breastfeeding patient\n21. Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care (e.g., positive human immunodeficiency virus \\[HIV\\] status, potential blood-borne infections,…), circumstance (e.g., sinus opening during surgery), psychological, morphological characteristics (e.g., skin characteristics, bone thickness), or any pre-existing comorbidities that in the investigator's opinion may prevent the implantation of the device, may impair the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical trial endpoints\n22. Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision\n\nExclusion Criterion:\n\nOccurrence of any major medical illnesses or impairments that in the Investigator's opinion may hampered the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical endpoints.",{"count":85,"type":21},560,[87],"PHASE3","The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.",[90,28,38],"Glioblastoma",[92,93,94,95],"carboplatin","SonoCloud","blood-brain barrier","Low Intensity Pulsed Ultrasound (LIPU)","2026-06-30",{"date":69,"type":54},{"date":99,"type":54},"2024-01-29",{"date":101,"type":21},"2028-06-30",{"name":103,"class":104},"CarThera","INDUSTRY",49,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100610287","phase-2-adjuvant-temozolomide--5-aminolevulinic-acid--low-intensity-diffuse-ultrasound-sonodynamic-therapy-system-for-newly-diagnosed-glioblastoma-100610287","NCT07225621","Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma","Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy","Inclusion Criteria:\n\n1. Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements\n2. ≥ 18 and ≤ 80 years of age\n3. WHO performance status of ≤ 2 at screening\n4. Newly diagnosed Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.\n5. GBM patients that have an absence of disease progression post craniotomy and TMZ\u002FRT. Note: patients must have undergone prior tumor resection to the extent safely feasible (biopsy only are not eligible).\n6. Completion of chemoradiation consisting of radiotherapy (30 x 20 Gy, or equivalent regimen, eg 33 x 18 Gy), with ≥ 90% of the planned radiation therapy dose delivered and concomitant TMZ chemotherapy (75 mg\u002Fm2), \\>66% of the planned doses administered.\n7. Any toxicity attributable to recently completed chemoradiation must be resolved to the patient's baseline level or ≤ Grade 2 (except alopecia or lymphopenia).\n8. Adequate bone marrow and organ function, defined by the following laboratory values: A. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3 B. Platelet count ≥ 50,000 cells\u002Fmm3 C. Hemoglobin (Hgb) ≥ 8 g\u002Fdl D. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (ULN) E. Total bilirubin ≤ 3 x ULN (unless gilbert's syndrome, then patients may be eligible if total serum bilirubin is ≤ 5.0 x ULN or direct bilirubin is ≤ 3 x ULN) F. Creatinine clearance (CrCl) as estimated by Cockcroft-Gault equation of ≥ 50 ml\u002Fmin\n9. Adequate coagulation function defined as PT (prothrombin time)\u002FPTT (partial thromboplastin time) defined as either results within normal institutional values or not considered clinically significant \\\u003C1.5 x ULN.\n10. Non-pregnant, non-lactating females who are postmenopausal, surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use effective contraceptive methods as defined by the protocol during the study and for 30 days after the last investigational treatment, see Appendix 1. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) concentration ≥ 40 IU\u002FL, or at least 6 weeks following surgical menopause (bilateral oophorectomy). See Appendix 1, females on HRT and whose menopausal status is in doubt will be required to use one of the non-estrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n11. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to first 5-ALA administration\n12. Male patients must be surgically sterile (i.e., 3 months post- vasectomy) or willing to use a highly effective double-barrier contraception method (e.g., male condom with diaphragm or male condom with cervical cap) for the duration of the study and for at least 30 days following SDT treatment. Male patients must not donate sperm from the time of study drug dosing until 30 days following SDT treatment.\n13. No anti-cancer treatment during adjuvant setting after completion of radiation therapy with anything other than temozolomide on Day 2 (+\u002F-1 day) for 5 days per the approved Package Insert (PI).\n\nExclusion Criteria:\n\n1. Any component of the tumor in the infratentorial location (cerebellar or brainstem tumors are excluded)\n2. Bihemispheric disease or tumors that involve the bilateral corpus callosum, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement,\n3. Multi- centric disease (enhancing or non-enhancing) or multi-focal disease (defined as 2 separate areas of contrast enhancement measuring at least 1 cm that are not contiguous and cannot be encompassed in sonication field on either fluid-attenuated inversion recovery (FLAIR) or T2 hyperintensity.\n4. Leptomeningeal disease\n5. 6\\. A diagnosis of glioscarcoma by histopathology Intent to undergo treatment with the tumor treating fields (TTF) at any time during the study, use prior to screening is permitted.\n\n7\\. Corticosteroid use \\> 4 mg\u002Fday of dexamethasone (or equivalent), steroid dose should be stable or decreasing for ≥1 week prior to randomization 8. Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents 9. Hypersensitivity to 5-ALA or porphyrins 10. Patient head size \\> 16.6 cm in breadth (max width of head, above the ears) and \\> 21.3 cm in length (front to back) to ensure fit within the helmet transducer array. 11. Skull voids\u002Fdefects \\> 10 mm diameter if defect is open, or \\> 14 mm if defect is covered with titanium burr hole cover, titanium mesh, or similar repair hardware. Note, Longeviti Neuro Solutions or other sonolucent implants should be treated as open defects and therefore may not exceed 10 mm in diameter. 12. Hemorrhagic or ischemic stroke (including transient ischemic attacks) and central nervous system bleeding in the preceding 6 months that are not related to glioma surgery. History of prior intratumoral bleeding prior to screening is not an exclusion criterion; however, patients with a history of prior intratumoral or intracranial bleeding will undergo a non-contrast head CT to exclude acute bleeding. 13. Has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy 14. Patients who have clinically significant cerebral edema requiring urgent intervention (e.g., surgery, initiation of steroids, escalating doses of steroids). 15. Patients with rapid clinical deterioration that, in the opinion of the investigator, is likely to worsen during the first cycle of treatment. 16. Any prior treatment for glioma, aside from surgical resection, and chemoradiation with TMZ. TTF is permitted prior to study entry. Agents used for diagnosis, imaging or visualization, even if investigational, are not exclusionary. Exclusionary treatments would include, but are not limited to: A. Stereotactic radiosurgery B. Placement of Gliadel® (carmustine; BCNU) wafers C. Any other intratumoral or intracavity treatment, D. Receipt of other chemotherapies, bevacizumab, immunotherapy (including vaccine) or investigational agents. 17. Acute or chronic types of porphyria. 18. Gastrointestinal disorder that negatively affects absorption. 19. Known active hepatitis B or C (Note: testing is not required). 20. Known human immunodeficiency virus (HIV) infection (Note: testing is not required). 21. Participation in another interventional clinical trial for GBM. (Observational studies are allowable) 22. Unable to avoid phototoxic drugs (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, and tetracyclines) for 24 hours prior to and following 5- ALA administration. 23. Any other concurrent severe or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, cardiac disease, clinically significant psychiatric or neurological disorder, active or uncontrolled infection). 24. Women who are pregnant or breastfeeding 25. Patients with a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.","80 Years",{"count":115,"type":21},103,[25],"The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a \"sham\" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.",[90,38],"2026-06-19",{"date":121,"type":54},"2026-06-23",{"date":123,"type":54},"2026-01-28",{"date":125,"type":21},"2028-12",{"name":127,"class":104},"Alpheus Medical, Inc.",10,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":62},"100622749","early-phase-1-imaging-acetadote-metabolism-in-glioblastoma-100622749","NCT07387666","Imaging Acetadote Metabolism in Glioblastoma","A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* 1\\. Glioblastoma\n* 2\\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent\n* 3\\. Age ≥18 years\n* 4\\. KPS \\> 70\n* 5\\. Adequate organ and marrow function as defined below:\n* \\- Bilirubin ≤1.5 times upper limit of normal\n* \\- AST and ALT ≤ 3 times ULN\n* \\- Creatinine ≤ 1.5 x ULN and\u002For GFR ≤ 60 mL\u002Fmin\n* -ANC ≥ 1000 cells\u002Ful\n* \\- Platelet ≥ 100,000\u002Ful\n* \\- Hemoglobin ≥ 9 g\u002Fdl\n* 6\\. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n* \\- Has not undergone a hysterectomy or bilateral oophorectomy; or\n* \\- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* 7\\. Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.\n* 2\\. Subjects must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).\n* 3\\. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.\n* 4\\. Brain metastases\n* 5\\. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote.\n* 6\\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.\n* 7\\. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.",{"count":128,"type":21},[138],"EARLY_PHASE1","This goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors.\n\nThe investigators are evaluating how Acetadote affects glioblastoma metabolism by using MRI-based methods and by determining the changes in metabolism in brain tumor tissue resected from patients with a new diagnosis of glioblastoma.",[90,38],"2026-06-18",{"date":121,"type":54},{"date":141,"type":54},{"date":145,"type":21},"2028-07-01",{"name":147,"class":148},"University of Texas Southwestern Medical Center","OTHER",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":164,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100618049","phase-2-study-of-silevertinib-with-temozolomide-for-the-treatment-of-newly-diagnosed-gbm-with-unmethylated-mgmt-and-egfrviii-100618049","NCT07326566","Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","Key Inclusion Criteria:\n\n* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).\n* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).\n* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.\n* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.\n* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.\n* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.\n* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.\n\nKey Exclusion Criteria:\n\n* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.\n* Progression of GBM prior to Enrollment, Screening, or Randomization.\n* Biopsy-only\u002Fno resectional surgery.\n* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.\n* Intent to use Optune® (TTF).\n* Significant other uncontrolled health conditions or other malignancies.",{"count":157,"type":21},162,[25],"The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.\n\nSpecifically, this study is being done to find answers to the following questions:\n\n* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?\n* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?\n* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?",[161,162,38,47,35,163,42],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","Central Nervous System Diseases",[165,90,166,167,168,169,170,171,172,173,174,175,176],"EGFR","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","temozolomide","Temodar","silevertinib","BDTX-1535","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)",{"date":178,"type":54},"2026-06-22",{"date":180,"type":54},"2026-05-05",{"date":182,"type":21},"2029-03",{"name":184,"class":104},"Black Diamond Therapeutics, Inc.",14,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":62},"100614068","safety-and-effectiveness-of-navifus-system-with-bevacizumab-in-recurrent-glioblastoma-100614068","NCT07274787","Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma","An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Adult male\u002Ffemale patients ≥ 18 years of age.\n2. Histologically confirmed glioblastoma at original diagnosis, recurrent after prior radiotherapy and temozolomide chemotherapy.\n3. Must have measurable disease ≥ 10mm (according to RANO criteria) .\n4. Interval since completion of radiation treatment (including radiation at original diagnosis and\u002For radiation for recurrent disease) ≥ 12 weeks.\n5. If on steroids, must be on a stable dose for ≥ 7 days prior to study treatment.\n6. Body mass index (BMI) ≥17 kg \u002F m2.\n7. Minimum interval since last drug therapy:\n\n   1. 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen), daily chemotherapy (e.g., metronomic temozolomide, cytoxan) or targeted therapies administered daily (e.g., gleevec, tarceva).\n   2. 4 weeks since last cytotoxic therapy.\n   3. 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine).\n8. Life expectancy ≥ 12 weeks.\n9. KPS Score \\> 60.\n10. Adequate hepatic, renal, coagulation, and hematopoietic function:\n\n    1. Hemoglobin ≥ 8 g\u002FdL.\n    2. Platelets ≥ 100,000\u002Fmm3.\n    3. Neutrophils ≥ 1,500\u002Fmm3.\n    4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN).\n    5. Urine protein creatinine (UPC) ratio \\\u003C 1 or urine dipstick for proteinuria ≤ 2+.\n    6. Alanine transaminase (ALT) \\\u003C 3 x ULN.\n    7. Aspartate transaminase (AST) \\\u003C 3 x ULN.\n    8. Prothrombin time ≤ 1.2 x ULN.\n    9. International Normalized Ratio (INR) \\\u003C 1.5.\n    10. Bilirubin \\\u003C 2 x ULN.\n11. Center of region of interest (ROI) (i.e., tumor site) ≥30mm deep to skull bone.\n12. If there is the potential for pregnancy, must agree to follow acceptable birth control methods to avoid conception.\n13. Able and willing to have their hair shaved (either whole head or the region where the coupling membrane will touch) and placement of peripheral IV line prior to treatment.\n\nExclusion Criteria:\n\n* 1\\) Previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR), including bevacizumab.\n\n  2\\) New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening.\n\n  3\\) Hypertension (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).\n\n  4\\) Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n  5\\) Unstable Pulmonary Disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.\n\n  6\\) Implanted pacemaker, defibrillator or deep brain stimulator, or other implanted electronic devices in the brain or documented clinically significant arrhythmias.\n\n  7\\) Major surgery such as intra-thoracic, intra-abdominal or intra-pelvic (with the exception of craniotomy), open biopsy or significant traumatic injury ≤ 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury.\n\n  8\\) Known human immunodeficiency virus (HIV) positivity.\n\n  9\\) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening.\n\n  10\\) Pregnant or breast-feeding women.\n\n  11\\) Known sensitivity\u002Fallergy to MRI contrast agents, CT contrast agents, SonoVue® \\[Lumason®\\], bevacizumab, or any of their components.\n\n  12\\) Abnormal baseline findings considered by the Investigator to indicate conditions that might affect study endpoints.\n\n  13\\) Hemorrhage or cyst within the ROI.\n\n  14\\) ROI in the deep center brain with crucial brain functions, such as in the region of the brain stem.\n\n  15\\) The receipt of an investigational drug within a period of 4 weeks prior to the first FUS exposure.\n\n  16\\) Use of any recreational drugs or a history of drug addiction.\n\n  17\\) Difficulty lying supine and still for the FUS procedure length.\n\n  18\\) Any other condition that, in the Investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.",{"count":128,"type":21},[195],"NA","This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.",[38],"NOT_YET_RECRUITING","2026-06-02",{"date":201,"type":54},"2026-06-04",{"date":203,"type":21},"2026-12-01",{"date":205,"type":21},"2029-12-01",{"name":207,"class":148},"University of Cincinnati",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":62},"100512623","surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-glioblastoma-100512623","NCT05954858","Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma","Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).\n2. TPFF and\u002For pericranial flap is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n3. Subject intends to participate in another clinical trial\n4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n5. Subject has an active infection requiring treatment.\n6. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n7. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n8. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n9. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":216,"type":21},32,[195],"This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.\n\nThe objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).",[41,90,32,220,40,38,42],"Glioblastoma Multiforme, Adult",[222,223,224,225],"tissue autograft","blood brain barrier","pedicled temporoparietal fascial","pericranial flap","2026-05-28",{"date":228,"type":54},"2026-06-01",{"date":230,"type":54},"2023-06-29",{"date":232,"type":21},"2029-06-30",{"name":234,"class":148},"Northwell Health",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":62},"100514481","omental-tissue-autograft-in-human-recurrent-glioblastoma-multiforme-rgbm-100514481","NCT05979064","Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)","Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).\n2. Omental graft is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject intends to participate in another clinical trial.\n3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.\n10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.\n11. Subject who are unable to have an MRI scan for any reason.",{"count":128,"type":21},[195],"This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.",[35,41,90,32,246,38,42,40],"Glioblastoma Multiforme of Brain",[223,248,249,250,251],"omentum autograft","omental autograft","omentum","omental",{"date":228,"type":54},{"date":254,"type":54},"2023-04-04",{"date":256,"type":21},"2028-04",{"name":234,"class":148},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":62},"100460101","phase-3-repeated-superselective-intraarterial-cerebral-infusion-siaci-of-bevacizumab-with-temozolomide-and-radiation-compared-to-temozolomide-and-radiation-alone-in-newly-diagnosed-gbm-100460101","NCT05271240","Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM","A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Subject must be able to undergo MRI evaluation.\n6. Subject meets the following laboratory criteria:\n\n   i. White blood count ≥ 3,000\u002FμL ii. Absolute neutrophil count ≥ 1,500\u002FμL iii. Platelets ≥ 100,000\u002FμL iv. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).\n\nExclusion Criteria:\n\n1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.\n3. Subject intends to participate in another clinical trial\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject, if female, is pregnant or is breast feeding.",{"count":266,"type":21},432,[87],"Primary brain cancer kills up to 10,000 Americans a year. These 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.\n\nThe investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg\u002Fkg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I\u002FII clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.",[90,32,41,38,42,270,220],"Glioblastoma, IDH-wildtype",{"date":228,"type":54},{"date":273,"type":54},"2022-04-27",{"date":275,"type":21},"2028-04-01",{"name":234,"class":148},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":293,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":62},"100275179","phase-1-super-selective-intra-arterial-repeated-infusion-of-cetuximab-for-the-treatment-of-newly-diagnosed-glioblastoma-100275179","NCT02861898","Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Phase I\u002FII Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age.\n* Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)\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. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.\n* Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) 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 as to the potential 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 initiated or completed chemo\u002FRT",{"count":285,"type":21},33,[24,25],"Primary brain cancer kills up to 10,000 Americans a year. These 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 EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol).\n\nThis trial will be a non-randomized open label Phase I\u002FII clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.",[90,42,289,290,291,292,38],"Brain Neoplasm","Brain Tumor","Brain Neoplasm, Malignant","EGFR Gene Overexpression",[165,294,175],"Epidermal Growth Factor Receptor",{"date":228,"type":54},{"date":297,"type":4},"2016-06",{"date":299,"type":21},"2029-12",{"name":234,"class":148},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":62},"100519143","phase-1-sonodynamic-therapy-in-patients-with-recurrent-gbm-100519143","NCT06039709","Sonodynamic Therapy in Patients With Recurrent GBM","Pilot Study of Sonodynamic Therapy With 5-ALA for the Treatment of Recurrent Glioblastoma Using Neuronavigation-Guided Low-Intensity Focused Ultrasound","GBM 001","Inclusion Criteria:\n\n1. Disease status and Disease Parameters:\n\n   * Suspected recurrent glioblastoma that is clearly measurable based on the modified Response Assessment in Neuro-Oncology (RANO) criteria\n   * The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 2 cm3 and ≤ 20 cm3 of targeted treatment area\n   * Tumor tissue to be treated is in a surgically accessible brain region for resection\n   * The brain tumor to be treated must be in the treatment envelope of the NaviFUS system (30 mm to 90 mm from the inner skull table)\n   * Recurrence will be assessed by imaging and confirmed by consensus at tumor board\n2. Men or women between the ages of 18-80 years of age at the time of consent\n3. No contraindication to repeat brain surgery\n4. Karnofsky Performance Score of 70-100\n5. Able to undergo an MRI with contrast\n6. Able to swallow oral medications\n7. Willingness and ability to comply with scheduled visits, treatment plans, lifestyle considerations, laboratory tests, and other procedures.\n8. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).\n9. Participants who received prior chemotherapy, radiation therapy, immunotherapy, and\u002For another investigational therapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1 or baseline) from the acute effects of the therapy or therapies) except for residual alopecia or Grade 2 peripheral neuropathy prior to registration.\n10. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):\n\nHematological\n\n* Absolute neutrophil count (ANC) ≥1000\u002Fmm3\n* Platelets ≥ 100,000\u002Fmm3\n* Hemoglobin ≥ 11 g\u002FdL for women and ≥ 12 g\u002FdL for men Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.\n* INR ≤ 1.4\n\nRenal \\& Hepatic\n\n* Creatinine clearance CrCl ≥ 60 mL\u002Fmin\u002F1.73 m2 as estimated by the Cockcroft-Gault (C-G) equation. If estimated CrCl is abnormal, accurate measurement should be obtained by 24- hour CrCl.\n* Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 2.0x ULN is allowed).\n* AST and ALT ≤ 3 x ULN\n* Alkaline phosphatase ≤ 3 x ULN\n* Estimated glomerular filtration rate ≥30mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n1. Known sensitivity or allergy to 5-ALA\n2. Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)\n3. Diagnosis of porphyria\n4. Hypersensitivity against porphyrins\n5. Pregnancy\n6. Significant cardiac disease or coagulopathy\n7. Herniation \u002F intractable seizure \u002F other clinical indications requiring urgent resection\n8. Known active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive)\n9. Have had a recent (≤3 months prior to registration) transient ischemic attack or stroke\n10. Significant vascular disease (e.g. aortic aneurysm)\n11. Evidence of bleeding diathesis or coagulopathy\n12. Need for systemic anticoagulation which cannot be held for 7 days prior to SDT\n13. Unstable angina and\u002For congestive heart failure (NYH Class III or Class IV; see section 13.2) within 6 months prior to registration\n14. Severe hypertension (systolic ≥ 180 mm Hg; diastolic ≥ 120 mm Hg) despite anti-hypertensive medications\n15. Transmural myocardial infarction within 6 months prior to registration\n16. Serious and inadequately controlled cardiac arrhythmia\n17. Acute exacerbation of chronic obstructive pulmonary disease\n18. Has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study\n19. Treatment with another investigational drug or investigational procedure within 30 days prior to registration or within 5 half-lives of the investigational product, whichever is longer\n20. Brain edema and\u002For mass effect that causes midline shift of more than 15 mm\n21. Evidence of recent (within 30 days prior to registration) intracranial hemorrhage\n22. Calcifications or metallic implanted objects in the focused ultrasound sonication path\n23. Scalp atrophy or scars at the expected location of transducer\n24. Cerebral or systemic vasculopathy\n25. Need for or currently on dialysis\n26. Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).\n27. Receipt of radiotherapy ≤21 days prior to registration\n28. Receipt of chemotherapy ≤ 21 days prior to registration\n29. Prior treatment with sonodynamic therapy\n30. Concurrent use of Optune device\n31. Concurrent use of supplements or medications with substantial antioxidant effects (including sulfhydryl-containing medications such as captopril or supplements such as N-acetylcysteine, or high doses of vitamins with antioxidant activity such as C or E)\n32. Known sensitivity to gadolinium",{"count":310,"type":21},11,[24],"Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent GBM. Focused ultrasound (FUS) can be used to non-invasively destroy tumor tissue while preserving normal tissue. When FUS is combined with 5-ALA, this combinatorial approach is called sonodynamic therapy (SDT), and this investigational therapy is being tested for its ability to cause damage to GBM cells. SDT will take place prior to surgery for recurrent GBM.",[28,32,38],[315,316,317,318,42],"Sonodynamic Therapy","Low-Intensity Focused Ultrasound (LIFU)","Focused Ultrasound","5-ALA","2026-04-27",{"date":321,"type":54},"2026-04-28",{"date":323,"type":54},"2024-01-31",{"date":325,"type":21},"2027-06",{"name":327,"class":148},"Shayan Moosa, MD",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":349,"locationsCount":351},"100445904","wbsi-guided-personalized-delivery-of-ttfields-100445904","NCT05086497","WBSI Guided Personalized Delivery of TTFields","Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields","Inclusion Criteria:\n\n* Adult population ≥ 22 years\n* Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria\n* Have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cGy in 6 weeks or a hypofractionated course of 4000 cGy in 3 weeks\n* 3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and\u002For isocitrate dehydrogenase (IDH) mutant or IDH wild-type)\n* Possessing adequate hematological, hepatic and renal functions\n* Willingness to receive TTFields\n\nExclusion Criteria:\n\n* Presence of infra-tentorial GBM\n* Pregnancy\n* Significant co-morbidities at baseline which would prevent maintenance TMZ treatment\n* Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators,pacemakers, defibrillators and programmable shunts. , other implanted electronic devices in the brain.\n* Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.\n* Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.","22 Years",{"count":337,"type":21},155,[195],"This research study is for Glioblastoma (GBM) patients who will be beginning Optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (TTFields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. As a part of this study, participants will either receive Optune with \"standard array mapping\" (based on regular contrast enhanced MRI) or an \"alternative (more precise) array mapping\" based on sophisticated state of the art MRI techniques including \"whole brain spectroscopy\". Whole brain MRI spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular MRI), by identifying certain metabolites that are present in cancer cells versus healthy tissue. This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of TTFields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.",[38,341,342],"Glioma Glioblastoma Multiforme","Tumor, Brain","2026-03-09",{"date":345,"type":54},"2026-03-11",{"date":347,"type":54},"2023-01-15",{"date":96,"type":21},{"name":350,"class":148},"Abramson Cancer Center at Penn Medicine",2,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":62},"100622535","surgery-and-laser-interstitial-thermal-therapy-for-bilateral-glioblastomas-100622535","NCT07384884","Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas","SLITT-GBM","Inclusion Criteria:\n\n1. Presumptive diagnosis of bGBM as per preoperative MRI and MDT assessment\n2. Presumed residual \u002F smaller component of the bGBM has to be \\\u003C 2.5cm\n3. Performance Status 0-1\n4. Able to consent for the study\n\nExclusion Criteria:\n\n1. bGBM measuring \\>2.5 cm in both hemispheres.\n2. Tumour progression between surgical debulking and LITT treatment\n3. Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)",{"count":360,"type":21},12,[195],"Butterfly glioblastomas (bGBM), defined as tumours crossing the midline to involve hemispheres bilaterally, have a dismal prognosis with a median survival of 3.3-6 months and only 9% of patients with bGBM survive 2-years. These figures put bGBM in the worst end of the spectrum of GBM prognosis, significantly inferior to the survival figures quoted in the literature with standard of care - 14.6 months - particularly when 5-aminolevulinic acid is used as surgical adjuvant - 17.47 months.\n\nDespite the poor outcome of this disease, there is preliminary evidence suggesting that active oncology treatment can impact the survival of patients with this condition.With particular regards to surgical resection versus biopsy, there is a suggestion that resection improves overall survival at 6 months with no clear difference at 12 and 18 months of follow up.\n\nLaser-induced thermal therapy (LITT) is a minimally invasive laser ablation technique used in a range of brain tumours, including glioblastomas, with similar overall survival to the ones reported for open surgery in patients with lesions not amenable to open resection. The minimally invasive nature of this technique, significantly reducing the collateral damage to the surrounding brain structures, suggests Its potential in the treatment of this bGBM \\[14\\] with significant implications as a deficit-sparing technique, particularly if associated with preoperative and intraoperative monitoring and mapping techniques.\n\nThe SLITT-GBM study will combine unilateral open surgery for maximal tumour resection with contralateral LITT to the smaller component\u002Fresidual.",[364,38],"Brain Tumours",[366],"brain tumour","2026-02-17",{"date":369,"type":54},"2026-02-19",{"date":371,"type":21},"2026-03-01",{"date":373,"type":21},"2027-07-01",{"name":375,"class":148},"King's College Hospital NHS Trust",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":62},"100492027","phase-1-adenovirus-mediated-suicide-gene-therapy-with-radiotherapy-in-progressive-astrocytoma-100492027","NCT05686798","Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.","Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas","Inclusion Criteria:\n\n1. Subjects with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma.\n\n   To be eligible for this trial, the subjects must have:\n   * Histologically documented glioblastomas or anaplastic astrocytoma prior to the debulking surgery that is suspicious to have progressed on imaging. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiation while at least 4 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.\n   * Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study.\n   * Must have recovered from toxicity (grade 2 or less) of prior therapy.\n   * Eligible for partial or total resection of the recurrent tumor\n   * No anticipated physical connection between post-resection tumor cavity and cerebral ventricle\n   * Karnofsky performance status (KPS) ≥ 60 at time of surgery\n   * No prior treatment of the tumor with gene or virus therapy, immunotherapy, brachytherapy, or implants of polymers containing chemotherapeutic agents (e.g. Gliadel Wafer)\n   * No immunosuppressive or immune disorder\n   * Baseline organ function testing intact\n   * Patients who are candidates for surgical debulking (re-resection) following recurrence of diseases based on multidisciplinary evaluation by neurosurgeons, radiation oncologists, neuro-radiologists, and neuro-oncologists.\n2. Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:\n\n   * Adequate renal function with creatinine clearance ≥ 50 mL\u002Fmin\u002Fm2\n   * Platelet count ≥ 100,000\u002FμL\n   * Absolute neutrophil count ≥ 1,000\u002FμL\n   * Hemoglobin \\> 10.0 g\u002FdL\n   * Bilirubin \\\u003C 1.5 mg\u002FdL; SGOT and SGPT \\\u003C 2.5 times upper limit of normal (ULN).\n3. Women of child-bearing potential will be required to practice birth control for the duration of the treatment and for at least 90 days after surgery with intratumor virus inoculation. Men must use barrier protection for the duration of treatment and for at least 90 days after surgery with intratumor virus inoculation treatment.\n\nExclusion Criteria:\n\n* Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required active treatment and caused oral temperature \\>38.5oC and\u002For clinically significant leukocytosis\n* Serum antibodies to human immunodeficiency virus (HIV)\n* Previous history of liver disease including autoimmune or viral hepatitis\n* Positive serologic test for Hepatitis B or C at baseline\n* Immunosuppressive therapy except for corticosteroid use\n* Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial\n* Impaired immunity or susceptibility to serious viral infections\n* Pregnant or lactating females\n* Allergy to any product used on the protocol\n* Patient is not able to undergo a brain MRI.\n* Patients who are not eligible for debulking surgery or resection of recurrent disease will be considered ineligible.",{"count":384,"type":21},18,[24],"The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.",[388,389,390,290,35,42,90,32,38],"Malignant Glioma of Brain","Astrocytoma","Malignant Astrocytoma","2025-12-08",{"date":393,"type":54},"2025-12-16",{"date":395,"type":54},"2022-11-29",{"date":397,"type":21},"2027-12",{"name":399,"class":148},"Henry Ford Health System",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":416,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":62},"100606728","phase-1-focused-ultrasound-blood-brain-barrier-disruption-for-the-treatment-of-high-grade-glioma-in-patients-undergoing-standard-chemotherapy-100606728","NCT07179328","Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Assessment of Safety and Feasibility of Focused Ultrasound Next Generational Dome Helmet Mediated Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Inclusion Criteria:\n\n1. Age between 18 and 85 years, inclusive.\n2. Able and willing to provide written informed consent.\n3. Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.\n4. Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.\n5. Tumor or tumor resection cavity is clearly defined on screening MRI scans.\n6. Karnofsky Performance Score rating 70-100.\n7. American Society of Anesthesiologists (ASA) physical status score of 1-3.\n8. Life expectancy of at least 3 months and able to attend all study visits.\n\nExclusion Criteria:\n\n1. Patients presenting with the following imaging characteristics:\n\n   i. Following steroid treatment, brain edema and\u002For mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm.\n\n   ii. Evidence of recent (less than 2 weeks) intracranial hemorrhage. iii. Calcifications in the FUS sonication beam path in the event system tools cannot tailor the treatment around these calcification spots.\n2. The sonication pathway to the tumor involves:\n\n   i. 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\n   ii. Clips or other metallic implanted objects in the skull or the brain, except shunts.\n3. The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).\n4. Patients requiring increasing doses of corticosteroids.\n5. Patient receiving bevacizumab (Avastin) therapy.\n6. Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative MRI. This cut-off is used to differentiate between pseudoprogression (which can occur following both radiation and TMZ therapy) and true tumor progression. This will be further ascertained through a discussion between the study neurosurgeons and radiologists.\n7. Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence.\n8. Cardiac disease or unstable hemodynamics including:\n\n   i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \\\u003C50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.\n9. Severe hypertension (diastolic blood pressure (DBP) \\> 100 on medication).\n10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).\n11. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.\n12. Abnormal level of platelets (\\\u003C 100,000) or INR \\> 1.3.\n13. Documented cerebral infarction within the past 12 months.\n14. TIA in the last 1 month.\n15. Cerebral or systemic vasculopathy.\n16. Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.\n17. Known sensitivity to gadolinium-DTPA.\n18. Known sensitivity to DEFINITY® ultrasound contrast agent or perflutren.\n19. Contraindications to MRI such as non-MRI-compatible implanted devices, unable to tolerate an MRI due to for instance pain or claustrophobia, untreated, uncontrolled sleep apnea.\n20. Positive pregnancy test (for pre-menopausal women).\n21. Known life-threatening systemic disease.\n22. Severely impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 and\u002For on dialysis.\n23. Right to left or bi-directional cardiac shunt.\n24. Previous full course of chemotherapy for GBM (at the discretion of investigator).\n25. Previous radiotherapy.\n26. Allergy to eggs or egg products.\n27. Subjects with evidence of cranial or systemic infection.\n28. Subjects with chronic pulmonary disorders.\n29. Subjects with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular subjects with a history of anaphylaxis.\n30. Subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation, or QT prolongation observed on screening ECG (QTc \\> 450 for men and \\>470 for women).\n31. Subjects with evidence of Hepatitis B virus infection\u002Fcarrier state.\n32. Liver injury as indicated by liver function tests that in the Investigator's opinion precludes participation in the study.","85 Years",{"count":128,"type":21},[24],"The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard \"Stupp protocol\".\n\nParticipants will:\n\n* Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy.\n* Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption.\n* Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening.\n* Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response.\n* Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.",[38,47,246,412,413,35,414,415],"Glioblastoma Multiforme Glioma","HGG","Brain Tumor Adult","Brain Tumor, Primary",[317,417,38,418,419,420,421,422,423,424,425],"FUS","TMZ","Temozolomide","blood-brain barrier disruption (BBBD)","MR-guided Focused Ultrasound (MRgFUS)","Glioblastoma multiforme","blood-brain barrier opening","Drug delivery","Chemotherapy delivery","2025-09-10",{"date":428,"type":54},"2025-09-17",{"date":430,"type":54},"2025-06-04",{"date":432,"type":21},"2027-11",{"name":434,"class":148},"Sunnybrook Health Sciences Centre",{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":450,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":62},"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.","70 Years",{"count":444,"type":21},25,[24,25],"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.",[448,449,38],"Brain Gliomas","High-Grade Gliomas",[451,452,453],"B7-H3","CAR-γδT","allogeneic","2025-08-13",{"date":456,"type":54},"2025-08-19",{"date":458,"type":54},"2023-06-01",{"date":460,"type":21},"2027-12-31",{"name":462,"class":148},"Dushu Lake Hospital Affiliated to Soochow University",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":484},"100506821","phase-1-evaluation-of-eflornithine-plus-temozolomide-in-patients-with-newly-diagnosed-glioblastoma-or-astrocytoma-100506821","NCT05879367","Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A\u002FB intact) per WHO 2021 tumor classification.\n* Completed external beam radiation therapy per standard of care.\n* Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.\n* Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.\n* Willing to abstain from intercourse or use acceptable contraceptive methods.\n* If taking corticosteroids, must be on a stable or decreasing dose.\n\nExclusion Criteria:\n\n* Recent history of recurrent or metastatic cancer that could confound response assessments\n* Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).\n* Prior Optune treatment.\n* Active infection or serious intercurrent medical illness.\n* Poorly controlled seizures.\n* Significant cardiac disease within 6 months of enrollment.\n* Poorly controlled diabetes.\n* Use of another investigational agent within 30 days of enrollment.",{"count":471,"type":21},66,[24],"The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.",[270,90,32,29,38,389,475],"Astrocytoma, IDH-Mutant","2025-06-19",{"date":478,"type":54},"2025-06-25",{"date":480,"type":54},"2023-07-24",{"date":96,"type":21},{"name":483,"class":104},"Orbus Therapeutics, Inc.",8,{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":16,"minAge":492,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":508},"100371391","phase-2-evaluate-the-efficacy-and-safety-of-adcv01-as-an-add-on-treatment-for-primary-glioblastoma-multiforme-gbm-patients-100371391","NCT04115761","Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients","A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients","Inclusion Criteria:\n\nStage I (Pre-screening)\n\n1. Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.\n2. Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo craniotomy tumor excision, and are willing to preserve the resected tumor cells enabling the production of ADCV01.\n3. Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).\n4. Only one GBM tumor number.\n5. Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study.\n6. Patients have the expected life expectancy of \\> 12 weeks at the pre-screening visit as judged by the investigator.\n7. Patients with stable vital sign and KPS ≥ 70 at the pre-screening visit.\n8. Patients with adequate renal function at the pre-screening visit:\n\n   serum creatinine \\\u003C 1.8 mg\u002FdL; creatinine clearance \\> 30 mL\u002Fmin\n9. Patients with adequate liver function at the pre-screening visit:\n\n   AST, ALT, and ALP ≤ 3× upper limit of normal (ULN); and total bilirubin \\\u003C 3 mg\u002FdL\n10. Patients with prothrombin time and activated partial thromboplastin time ≤ 1.5× ULN at the pre-screening visit\n11. Patients with adequate hematopoietic function at the prescreening and before administration of study medication\n\n    1. Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FμL\n    2. Platelets ≥ 100,000 counts\u002FμL\n    3. Total white blood cell (WBC) ≥ 2,000 cells\u002FμL\n    4. Hemoglobin ≥ 8 g\u002FdL\n12. All male and female patients with child-bearing potential (between puberty and 2 years after menopause) must be practicing sexual abstinence and be willing to continue to use a medically acceptable form of birth control for at least 1 month prior to screening (that period will extend to 3 months for oral contraceptive use). The patients should use appropriate contraceptive method(s) as shown below, until at least 6 months after the last dose of ADCV01 administration.\n\n    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, thermal symptom post-ovulation methods) and withdrawal are not acceptable methods of ontraception).\n    2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before administration of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n    3. Male sterilization (at least 6 months prior to screening). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject\n    4. Combination of any two of the following listed methods:\n\n    (d.1+d.2 or d.1+d.3, or d.2+d.3): d.1 Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception. d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n13. Patients agree to be in compliance with treatment plan as planned in the clinical protocol.\n\n    Stage II (Screening\u002FRandomization) In addition to fulfill the criteria in Stage I, following criteria should be met to be eligible for remaining in the study.\n14. Patients' resected brain tumors are pathologically confirmed cases of the IDH-1 wild-type glioblastoma, and patients are willing to do monocyte-collecting apheresis at the screening\u002Frandomization visit.\n15. At the screening\u002Frandomization visit, patients' resected brain tumors are confirmed of low PD-1+\u002F CD8+ ratio (ratio \\\u003C0.21).\n16. Residual tumor with less than 25% contrast-enhancing mass on post-surgical brain MRI (within 2 days post-operation) as assessed by the neurosurgeon and\u002For radiologist.\n\nExclusion Criteria:\n\nStage I (Pre-screening)\n\n1. Number of GBM is more than one\n2. Patient who has participated in other investigational studies within 4 weeks prior to pre-screening\n3. Patient with known or suspected hypersensitivity to ADCV01 or its excipients\n4. Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and Stevens-Johnson syndrome) to dacarbazine (DTIC) or any components of medications of temozolomide and bevacizumab\n5. Patient has acute infectious disease or acute cardiovascular disease; clinically manifest myocardial insufficiency or history of myocardial infarction during the past 6 months prior to prescreening; or has active uncontrolled arterial hypertension as supported by medical history.\n6. Patient has clinically significant immuno-compromised condition (other than that related to the use of corticosteroids), is human immunodeficiency virus positive (anti-HIV and nucleic acid test) or medical condition requiring systemic immunesuppressive treatments.\n7. Patient with active rheumatic disease or other collagen vascular disease, or is with active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition, only requiring hormone replacement therapy are permitted to enroll.\n8. Patients with psoriasis requiring systemic therapy, or conditions expected to recur in the presence of an external trigger\n9. Patient with syphilis, acute HBV, HCV (except hepatitis carriers), HTLV-I\u002FII, CMV, or an increased risk (or has been diagnosed) for human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob disease (CJD)\n10. Patient with history of coagulation disorder associated with bleeding or recurrent thrombotic events\n11. Patient with medical, social, or psychological factors interfering with compliance of the study\n12. Female patient who is lactating, pregnant, or planned to be pregnant\n13. Inability to undergo MRI for any reason\n14. History of malignancy other than glioma that is not stable in the past 5 years prior to pre-screening (informed consent form signing date)\n15. Patient not suitable to participate the trial as judged by the investigator. Stage II (Screening\u002FRandomization)\n\n    The patient will be no longer eligible to participate the study if he\u002Fshe met any of the following criteria:\n16. GBM patients with high PD-1+\u002FCD8+ ratio ≥ 0.21\n17. GBM patients with mutant IDH-1\n18. Residual tumor volume more than 25% of pre-operative tumor size.","20 Years","75 Years",{"count":495,"type":21},24,[25],"This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme",[38],"2024-09-10",{"date":501,"type":54},"2024-09-19",{"date":503,"type":54},"2019-06-06",{"date":505,"type":21},"2026-12-30",{"name":507,"class":104},"Ever Supreme Bio Technology Co., Ltd.",3,{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":516,"sex":16,"minAge":517,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":62},"100546556","early-phase-1-clinical-study-of-allogeneic-v9v2-t-cells-in-the-treatment-of-brain-malignant-glioma-100546556","NCT06396481","Clinical Study of Allogeneic Vγ9Vδ2 T Cells in the Treatment of Brain Malignant Glioma","CSAγδTBMG","Inclusion Criteria:\n\n* Patients with clinically diagnosed malignant brain glioma in an important structural area (WHO Grade IV);\n* Patients with poor postoperative effect or ineffective guidelines for conventional treatment\n* Age ≥4 years old, male or female;\n* KPS score ≥70;\n* Normal bone marrow reserve function and normal liver and kidney function (as evidenced by the following laboratory tests prior to initial Vγ9Vδ2 T cell therapy) :\n* Neutrophil absolute value ≥ 1,500\u002Fmm3;\n* hemoglobin 10g\u002FdL;\n* Platelet count \\> 100,000\u002Fmm3;\n* Glutamic pyruvic transaminase\u002FGlutamic oxalacetic transaminase \\< 2.5 x ULN;\n* Serum creatinine 1.5×ULN;\n* Total bilirubin levels \\< 1.5 x ULN.\n* No obvious genetic diseases;\n* Normal cardiac function, cardiac ejection index \\> 55%;\n* Suitable for implantation of Ommaya capsule in ventricle or cavity;\n* No bleeding and coagulation disorders;\n* Women of reproductive age (15-49 years) must undergo a negative pregnancy test within 7 days before starting treatment and use contraception during the clinical trial period and within 3 months after the last cell transfusion;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant and lactating women;\n* Organ failure;\n* Heart: Grade III and grade IV;\n* Liver: Level C of the Child-Turcotte liver function scale;\n* Kidney: renal failure and uremia stage;\n* Lungs: Symptoms of severe respiratory failure;\n* Brain: A person with a disorder of consciousness.\n* Patients with a history of organ transplantation;\n* Uncontrollable infectious disease or other serious illness, including but not limited to infection (such as HIV positive), congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or restrictive social environment or what the attending physician considers to be an unpredictable risk;\n* Patients with systemic autoimmune disease or immunodeficiency;\n* Patients with allergic constitution;\n* Use of systemic steroid drugs;\n* Have a chronic disease that requires the use of immune agents or hormone therapy;\n* Prior treatment with any other immune cell;\n* Have participated in other clinical trials within the past 30 days;\n* The researchers believe that other reasons are not suitable for clinical trials",true,"4 Years",{"count":444,"type":21},[138],"Primary brain malignant tumor has become the first lethal tumor in children and young adults, and the treatment is limited, and the prognosis of patients is poor. According to the classification of the World Health Organization, glioblastoma is divided into grade II, III and IV gliomas; The higher the degree of malignancy, the worse the clinical outcome. Among them, the most malignant, most lethal, and most common types of tumors include supratentorial glioblastoma, diffuse endopontine glioma (DIPG), medulloblastoma, and ependymoma. Its high malignancy is mainly manifested in three aspects: extremely rapid growth and obvious invasion; The operation is not easy to remove all; The tumor has a tendency of recurrence and disseminated implantation. It can occur with children and adults of all ages. At present, surgery combined with chemoradiotherapy is the main treatment, but the therapeutic effect is not good. Studies have shown that glioblastoma, as the most common primary brain malignant tumor in adults, after standard surgery, radiotherapy and chemotherapy, the median survival time is less than 15 months, and the overall five-year survival rate is only 5.4%. Even after receiving new and expensive Tumor-treating fields, the median survival time is less than 21 months. The median survival time of DIPG patients is generally less than 1 year, and the 5-year survival rate is less than 5%. The average 5-year survival rate of medulloblastoma and anaplastic ependymoma is 40%\\~60%. Innovative treatments are urgently needed. Immunotherapy based on Vγ9Vδ2 T cells has become a promising research direction in recent years. Its unique phosphine antigen recognition does not depend on major histocompatibility complex (MHC), easy to allograft and other advantages. Making it one of the most promising cell therapies. Brain glioma has abnormal cholesterol metabolism and phosphine antigen accumulation, which is easily sensed by Vγ9Vδ2 T cells. Therefore, the clinical exploration of Vγ9Vδ2 T cells for glioma is of great significance to both the scientific and clinical communities.",[38,522,523],"DIPG Brain Tumor","Medulloblastoma",[525,526],"malignant glioma","Vγ9Vδ2 T","2024-05-01",{"date":529,"type":54},"2024-05-02",{"date":531,"type":21},"2024-04-30",{"date":533,"type":21},"2027-12-30",{"name":535,"class":148},"Beijing Tiantan Hospital",{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":493,"enrollmentInfo":542,"targetDuration":4,"studyType":544,"phases":4,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":62},"100286167","integrative-analysis-of-human-glioblastoma-multiforme-100286167","NCT03005132","Integrative Analysis of Human Glioblastoma Multiforme","Inclusion Criteria:\n\n* Age ≤ 75 years with histologically proven GBM\n* No severe major organ dysfunction\n* World Health Organization (WHO) performance status of 0 or 1\n* No prior cancer chemotherapy\n\nExclusion Criteria:\n\n* Age ≥ 76\n* Severe major organ dysfunction\n* WHO performance status of \\>1\n* Prior cancer chemotherapy",{"count":543,"type":21},1000,"OBSERVATIONAL","Integrative analysis of GBM",[38],[548],"GBM; Integrative Analysis; WES","2016-12-23",{"date":551,"type":21},"2016-12-29",{"date":553,"type":4},"2016-01",{"date":555,"type":21},"2026-12",{"name":557,"class":148},"Shanghai 10th People's Hospital",{"id":559,"slug":560,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":442,"enrollmentInfo":4,"targetDuration":4,"studyType":566,"phases":4,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":577,"locationsCount":579},"100220361","expanded-access-protocol-for-gbm-patients-with-already-manufactured-dcvax-l-who-have-screen-failed-protocol-020221-100220361","NCT02146066","Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221","An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients With Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221","DCVax-L EAP","Inclusion Criteria:\n\n1. Screen-Fail for protocol 020221 due to either:\n\n   * Radiographic evidence of disease progression or pseudoprogression at the Baseline visit under protocol 020221, as determined by central imaging review, OR\n   * Insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses).\n2. Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales).\n3. Patients may have received steroid therapy as part of their primary treatment. Steroid treatment should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone qd at least 7 days prior to the first immunization .\n4. DCVax-L product manufactured and released.\n\nExclusion Criteria:\n\n1. Active uncontrolled infection, or acute infection requiring antibiotic or antifungal therapy. Antibiotic and antifungal therapy should be completed approximately 7 days prior to the first immunization.\n2. Fever ≥101.5oF. If considered possibly transient, retesting is allowed.\n3. Unstable or severe intercurrent medical conditions.\n4. Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm). 020221 Baseline lab results and or local lab results are acceptable.","EXPANDED_ACCESS","The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.",[38,32],[38,570,571,572],"Brain tumor","glioblastoma","Brain tumor WHO grade IV","AVAILABLE","2016-02-25",{"date":576,"type":21},"2016-02-26",{"name":578,"class":104},"Northwest Biotherapeutics",27]