[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,206,0,25,[9,42,76,104,125,147,171,201,224,254,294,324,357,387,409,431,449,474,499,520,552,599,619,640,659],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652581","tear-fluid-for-the-detection-of-tumor-associated-extracellular-vesicles-in-glioblastoma-patients-100652581",false,"NCT07775534","Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients","Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study","Inclusion Criteria:\n\n* Adults (age ≥ 18)\n* Male and female\n* All racial and ethnic groups\n* Pathologically-proven diagnosis of GBM or healthy volunteers\n* For GBM patients, presence of a previously placed Rickham reservoir or shunt\n* Able to provide informed consent (or via legal representative)\n* Willing to undergo Schirmer strip procedure\n\nExclusion Criteria:\n\n* Active ocular infection or inflammation\n* Recent ocular surgery (within 3 months)\n* Chronic dry eyes\n* Known allergy or hypersensitivity to topical anesthetics\n* Cognitive impairment\n* Pregnancy\n* Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study procedures or place the participant at undue risk",true,"ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This clinical trial tests the impact of tear fluid in detecting tumor-associated extracellular vesicles (TEVs) in patients with glioblastoma. Brain tumors release small particles, called TEVs, that may provide information about the tumor, including how it responds to treatment. These particles can be found in cerebrospinal fluid (CSF), which is the fluid that surrounds the brain and spinal cord. Collecting CSF can be difficult and expensive, especially if samples are needed frequently to track these particles over time. Tear fluid is easier to collect than spinal fluid. If tears are found to contain similar tumor-related particles, changes in the tumor may be tracked by studying the particles found in tear fluid.",[28],"Glioblastoma","NOT_YET_RECRUITING","2026-08-17",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":22},"2026-12-09",{"date":37,"type":22},"2027-09-19",{"name":39,"class":40},"City of Hope Medical Center","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100558856","phase-3-ef-41keynote-d58-phase-3-study-of-optune-concomitant-with-temozolomide-plus-pembrolizumab-in-newly-diagnosed-glioblastoma-100558856","NCT06556563","EF-41\u002FKEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41\u002FKEYNOTE D58).","EF-41","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative) has provided documented informed consent for the study.\n2. Be ≥ 18 years of age on day of providing informed consent.\n3. Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.\n4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is not allowed.\n5. Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.\n6. Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg\u002Fm\\^2 daily x 5, Q28 days).\n7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization.\n8. Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable.\n\nExclusion Criteria:\n\n1. Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137).\n2. Ongoing requirement for \\>2 mg dexamethasone (or equivalent), due to intracranial mass effect.\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.\n4. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first study treatment.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n7. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n8. Early progressive disease after the end of TMZ\u002FRT. If pseudo progression is suspected, additional imaging studies should be performed to rule out true progression.\n9. Infratentorial or leptomeningeal disease.",{"count":51,"type":22},741,[53],"PHASE3","This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).",[28],[57,58,28,59,60,61,62,63,64],"TTFields","Pembrolizumab","Tumor Treating Fields","Immunotherapy","Merck Sharp & Dohme LLC","GBM","KEYNOTE D58","MK3475-D58","RECRUITING",{"date":67,"type":33},"2026-08-19",{"date":69,"type":33},"2025-02-03",{"date":71,"type":22},"2029-04",{"name":73,"class":74},"NovoCure GmbH","INDUSTRY",102,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"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 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 a candidate for craniotomy and at least 50% resection of enhancing region\n5. Maximal enhancing tumor diameter prior to inclusion ≤ 5 (+7%) cm on T1w on MRI performed within 14 days prior to inclusion§. (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 (≤ grade 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 prior to 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\u002Fm2 using Appendix 12.4 formula\n   4. AST(SGOT)\u002FALT(SPGT) ≤ 3 X institutional ULN (upper Limit of Normal)\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 prior to 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\n(§) These exam\u002Flab tests could be (re)evaluated before randomization if the corresponding selection criteria could not be fully met at time of inclusion. If not met before randomization, the patient will be considered as screen failure.\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, known impaired wound healing and\u002For previously infected surgical field, uncontrolled diabetes 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, malnutrition…), 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":22},560,[53],"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.",[28,89,62],"Recurrent Glioblastoma",[91,92,93,94],"carboplatin","SonoCloud","blood-brain barrier","Low Intensity Pulsed Ultrasound (LIPU)",{"date":96,"type":33},"2026-08-18",{"date":98,"type":33},"2024-01-29",{"date":100,"type":22},"2028-06-30",{"name":102,"class":74},"CarThera",55,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100284068","phase-2-individualized-screening-trial-of-innovative-glioblastoma-therapy-insight-100284068","NCT02977780","INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)","Inclusion Criteria:\n\n* Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection. Tumors primarily localized in the infratentorial compartment will be excluded.\n* Participants may have had prior surgery for glioblastoma or gliosarcoma but no systemic or radiation therapy.\n* Age ≥ 18 years.\n* Karnofsky performance status ≥60\n* Participants must have normal organ and marrow function as defined below:\n\n  * Leukocytes ≥3,000\u002FmL\n  * Absolute neutrophil count ≥1,500\u002FmL\n  * Platelets ≥100,000\u002FmL\n  * Hemoglobin ≥ 9g\u002Fdl\n  * Total bilirubin within normal institutional limits (except for participant's with Gilbert's disease)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional upper limit of normal\n  * Creatinine ≤ institutional upper limit of normal OR\n  * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n  * Potassium within normal institutional range, or correctable with supplements\n  * Serum amylase ≤ 1.5 x institutional upper limit of normal\n  * Serum lipase ≤ 1.5 x institutional upper limit of normal\n  * INR \\\u003C 2.0\n  * PTT ≤ institutional upper limit of normal, unless receiving therapeutic low molecular weight heparin\n* Must be able to swallow pills.\n* Participants must plan to begin radiation therapy 14-42 days after surgical resection.\n* Immunohistochemically negative for IDH1 R132H mutation.\n* Evidence that the tumor MGMT promoter is unmethylated by standard of care assays.\n* Genotyping data available or in process (data must be available at time of initial registration if randomization probabilities differ across biomarker subgroups as determined by the DFCI Coordinating Center) to assign biomarker subgroups through whole exome sequencing, whole genome copy number analysis, or a combination as described in Section 9.1.\n* MRI with gadolinium should be obtained within 21 days prior to beginning treatment. Patients without measurable disease are eligible. Participants must be able to undergo MRIs (CTs are not allowed for response assessment on study).\n* The effects of the experimental agents used in this study on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (women who are not free from menses for \\> 2 years, post hysterectomy\u002Foophorectomy, or surgically sterilized) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation unless otherwise specified in sub-study that the participant is randomized to. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* For women of child bearing potential (women who are not free from menses for \\> 2 years, post hysterectomy\u002Foophorectomy, or surgically sterilized) a negative serum pregnancy test must be documented prior to initial registration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants will not be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis revealed glioblastoma.\n* Planned major surgery.\n* Participants who are receiving any other investigational agents.\n* Participants who have had any prior cranial radiotherapy.\n* Planned use of Optune™.\n* History of a different malignancy, unless (a) have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, and\u002For (b) malignancy was cervical cancer in situ, superficial bladder cancer or basal cell or squamous cell carcinoma of the skin, and malignancy has been treated. Patients who meet the above listed criteria and are only on preventative treatment will be deemed eligible.\n* History of intratumoral or peritumoral hemorrhage if deemed significant by the treating physician.\n* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n* Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of ≥2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.\n* Known history of congenital QT prolongation or Torsade de pointes (TdP).\n* Complete left bundle branch or bifascicular block.\n\n  --QTc interval \\> 450 ms for men or \\> 470 ms for women.\n* Persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation.\n* Unstable pectoris or myocardial infarction ≤ 3 months prior to starting study treatment.\n* Uncontrolled hypertension (blood pressure ≥ 160\u002F95 mmHg).\n* Other clinically significant heart disease such as congestive heart failure requiring treatment.\n* Uncontrolled diabetes mellitus, or subjects with either of the following:\n* Fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg\u002FdL (7.0 mmol\u002FL), or\n* HbA1c ≥ 8%\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Subjects must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.\n* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNS \\[qualitative\\] is detected).\n* Known acute or chronic pancreatitis.\n* Participants with active diarrhea ≥ CTCAE grade 2 despite medical management.\n* Active infection requiring antibiotics.\n* Pregnant or breastfeeding.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection). Participants with unresolved diarrhea ≥ CTCAE grade 2 will be excluded as previously indicated.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the experimental agents or other agents used in study.\n* Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off any EIAEDs for at least 7 days prior to planned start of study treatment. A list of EIAED and other inducers of CYP3A4 is provided. Among non-EIAED, caution is recommended with use of valproic acid due to potential for drug interaction.\n* Participants taking a drug known to be strong inhibitors or inducers of isoenzyme CYP3A. Participant must be off CYP3A inhibitors and inducers for at least 7 days prior to planned start of study treatment. NOTE: participants must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to planned start of study treatment and during the entire study treatment period due to potential CYP3A4 interaction.\n* Current use of herbal preparations\u002Fmedications, including but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng. Participants should stop using these herbal medications 7 days prior to planned start of study treatment.\n* Current use of warfarin sodium or any other coumadin-derivative anticoagulant. Participant must be off Coumadin-derivative anticoagulants for at least 7 days prior to planned start of study treatment. Low molecular weight heparin and factor Xa inhibitors are allowed.",{"count":111,"type":22},460,[113],"PHASE2","This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM).\n\nThe drugs involved in this study are :\n\n* Abemaciclib (arm is currently closed to accrual)\n* Temozolomide (temodar)\n* Neratinib (arm is currently closed to accrual)\n* CC115 (arm is currently closed to accrual)\n* QBS10072S",[28],[28],{"date":67,"type":33},{"date":119,"type":33},"2017-02-09",{"date":121,"type":22},"2028-04-30",{"name":123,"class":40},"David Reardon, MD",12,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100366130","feasibility-of-intraoperative-microdialysis-during-neurosurgery-for-central-nervous-system-malignancies-100366130","NCT04047264","Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions","Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Diagnosis of the following, based on clinical and radiographic evidence:\n\n  * Any glioma\n  * Metastatic brain tumor of any primary origin\n  * Epileptic focus requiring surgical resection\n* Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care\n* Willing to undergo neurosurgical resection or biopsy at Mayo Clinic \\[Rochester, Minnesota (MN)\\]\n* For patients with gliomas recruited for post-operative microdialysis, willingness to stay in the hospital through post-operative day (POD) 3-5 (timing per physician and patient's shared decision making)\n* Ability to understand and the willingness to sign a written informed consent document\n* Enrollment into the Biobank study (IRB#12-003458)\n\nExclusion Criteria:\n\n* Vulnerable populations: pregnant women, prisoners or the mentally handicapped\n* Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness",{"count":133,"type":22},100,[25],"This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intra- and post-operative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.",[137,28,138],"Glioma","Metastatic Malignant Neoplasm in the Brain","2026-08-14",{"date":96,"type":33},{"date":142,"type":33},"2020-01-01",{"date":144,"type":22},"2027-09-01",{"name":146,"class":40},"Mayo Clinic",{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":41},"100553930","phase-2-glioma-adaptive-radiotherapy-with-development-of-an-artificial-intelligence-workflow-100553930","NCT06492486","Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow","GLADIATOR","Inclusion Criteria:\n\n* Histological diagnosis of diffuse glioma. Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) need radiotherapy (stratum B).\n\nAge: 18-70 years. Karnofsky Performance Scale (KPS) ≥60\n\nExclusion Criteria:\n\n* Multifocal or multicentric disease Not eligible for radical intent radiation. IDH status is unknown or uninterpretable (IHC or gene sequencing). Use of prior radiotherapy to the head-neck region or brain or chemotherapy. Contraindication\u002Funable to undergo MRI or PET scan during radiation.","70 Years",{"count":156,"type":22},60,[113],"Gliomas are common primary brain tumors in adults. Gliomas can be classified into different types based on tumor grade, histopathological features, and molecular characteristics. The common types of diffuse gliomas include glioblastoma, astrocytoma, and oligodendroglioma. The standard treatment for diffuse gliomas includes surgery followed by radiation and chemotherapy. As per standard institutional practice, a uniform dose of radiation is delivered to the disease area and MRI is done before and after the treatment. In this study, MRI and PET scan will be done before starting the treatment and standard dose of radiation will be delivered. The interval imaging will be done twice during the course of treatment with MRI and PET, followed by dose modifications. The CT, MRI, and PET will be combined. Based on PET imaging, specific dose will be altered and delivered to specific areas. Dose modification will be done with the help of artificial intelligence. Participant's assessment will be done at regular intervals.\n\nModifications in radiation plans are done based on the changes in disease seen in scans is likely to improve the accuracy of RT treatments. Dose modifications based on imaging to resistant areas will help achieve better tumor control, reduce treatment-related toxicities, precise delivery of the RT and adjusting doses to the organs at risk (OAR) and changes in disease leading to better treatment compliance. Creating an artificial intelligence framework in radiation oncology promises to improve quality of workflow, treatment planning and RT delivery.\n\nThe aim of the study is to develop an artificial intelligence workflow for treatment of glioma with adaptive radiotherapy. This study will be conducted in Tata Memorial Centre on a population of 60 patients for a duration of 2 years. The total study duration is 4 years.",[160,28,161,162],"Diffuse Glioma","Adaptive Radiotherapy","Artificial Intelligence","2026-08-13",{"date":30,"type":33},{"date":166,"type":33},"2026-07-27",{"date":168,"type":22},"2028-07-30",{"name":170,"class":40},"Tata Memorial Centre",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":181,"phases":4,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":41},"100597007","the-effect-of-glioblastoma-psma-expression-following-tumour-vegf-blockade-from-bevacizumab-100597007","NCT07052877","The Effect of Glioblastoma PSMA Expression Following Tumour VEGF Blockade From Bevacizumab","Investigating Glioblastoma PSMA Expression by Utilizing Anti-VEGF and Its Effect on PSMA PET Scan Avidity","GUAVA","Inclusion Criteria:\n\n* \\> 18 year of age\n* ECOG 0-2\n* Able to provide informed consent for the study\n* Minimum of 1 month from completion of radiotherapy with clinical or radiography evidence suggesting residual tumour\n* Confirmed glioblastoma IDH1\u002F2 wildtype (WHO2021)\n* For bevacizumab treatment as per treating physician\n* Able to comply with trial requirements\n\nExclusion Criteria:\n\n* No major organ impairment that would likely lead to unacceptable toxicities- eg significant cardiac, hepatic, renal or haematologic dysfunction (based on clinician assessment)\n* Any contraindication to bevacizumab, MRI gadolinium contrast or 68Ga-PSMA-617 radioisotope\n* Any implant, foreign body, 3T MRI incompatible device or other contraindication to MRI imaging\n* Does not fulfill PBS requirements for bevacizumab\n* Women lactating, pregnant or of child baring potential who are not willing to avoid pregnancy during the study",{"count":180,"type":22},20,"OBSERVATIONAL","This trial is a single arm study for patients receiving bevacizumab for IDH-wildtype glioblastoma. Patients receiving bevacizumab (an anti-VEGF therapy) will receive PSMA scans to investigate the role of PSMA expression in glioblastoma and its relationship to VEGF expression.",[28,184],"Glioblastoma Multiforme (GBM)",[186,187,188,189,190,191,192],"glioblastoma","anti-VEGF","PSMA","bevacizumab","VEGF","glioma","astrocytoma","2026-08-11",{"date":163,"type":33},{"date":196,"type":33},"2025-12-11",{"date":198,"type":22},"2027-07",{"name":200,"class":40},"Royal North Shore Hospital",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":41},"100530409","phase-1-anti-egfrviii-synnotch-receptor-induced-anti-epha2il-13ralpha2-car-e-sync-t-cells-100530409","NCT06186401","Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2\u002FIL-13Ralpha2 CAR (E-SYNC) T Cells","Phase 1 Study of Autologous Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2\u002FIL-13R alpha2 CAR (E-SYNC) T Cells in Adult Participants With EGFRvIII+ Glioblastoma","Inclusion Criteria:\n\n* Inclusion Criteria for Cohort 1:\n\n  1. Age \\>= 18 years.\n  2. Karnofsky performance status (KPS) score of \\>=70.\n  3. All participants must have adequate organ function defined as:\n\n     1. Peripheral absolute neutrophil count \\>=1000\u002Fmm\\^3.\n     2. Platelet count \\>=100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n     3. Absolute lymphocyte count (ALC) \\>= 300\u002FμL and\u002For Cluster of differentiation 3 (CD3) count of \\>=150\u002FμL.\n     4. Creatinine clearance or radioisotope glomerular filtration rate \\>= 50 mL\u002Fmin\u002F1.73m\\^2.\n     5. Total Bilirubin \\\u003C= 1.5 x ULN except for Gilbert's syndrome and\n     6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 3x upper limit of normal (ULN).\n     7. Left ventricular ejection fraction (LVEF) \\>= 50% by echocardiogram or multi-gated acquisition scanning (MUGA).\n     8. Adequate pulmonary function, defined as no evidence of dyspnea at rest and pulse oximetry \\> 92% while breathing room air.\n  4. Pathological criteria: EGFRvIII+ GBM from most recent surgery, confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified lab using a next-generation sequencing panel.\n  5. MGMT promoter must be unmethylated or with a methylation index \\\u003C 3.\n  6. Must have completed at least standard of care (SOC) external beam radiotherapy (EBRT) as initial therapy.\n  7. Participants must be anticipated to be able to complete E-SYNC T cell infusion within 12 weeks after completion of EBRT.\n  8. All participants must be off systemic steroids for 3 days or more prior to leukapheresis.\n  9. Must be willing to provide voluntary informed consent for apheresis (and tissue screening if needed) and for study treatment.\n\nNOTE: There are two sets of eligibility criteria for Cohort 2. Tissue Screening: Defines eligibility for tissue screening and to determine H-score.\n\nStudy Enrollment: Defines eligibility for study enrollment and E-SYNC T cell manufacturing\u002Ftreatment.\n\n* Inclusion Criteria for Tissue Screening Cohort 2:\n\n  1. Age \\>=18 years.\n  2. Pathological criteria: EGFRvIII+ GBM from most recent surgery, confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified lab using a next-generation sequencing panel.\n* Inclusion Criteria for Study Enrollment for Cohort 2\n\n  1. Karnofsky Performance Scale (KPS) score \\>=70.\n  2. received at least standard of care external beam radiotherapy (SOC EBRT) as initial therapy, with or without concurrent temozolomide (TMZ), and completed the last dose of TMZ ≥23 days prior to study enrollment). Note: patients may have initiated adjuvant TMZ +\u002F- TTFields.\n  3. Pathological criteria: EGFRvIII+ GBM from most recent surgery, as defined by an EGFRvIII H-score of ≥ 150 based on central review.\n  4. Is surgically amenable, with expectation for ability to resect at least 500 mg of tumor tissue confirmed by participant's neurosurgeon.\n  5. Participants with reproductive potential agree to use reliable and double barrier method of contraception during the study and for at least 6 months after the last study intervention, including refraining from donating sperm during this period.\n  6. Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test prior to receiving study interventions.\n  7. All participants must have adequate organ function.\n\n     a. Adequate bone marrow function is defined as: i. Peripheral absolute neutrophil account ≥ 1000\u002Fmm3 and ii. Platelet count ≥ 100,000\u002Fmm3 (transfusion dependent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) and iii. Absolute lymphocyte count (ALC) ≥ 300\u002FµL and\u002For CD3 count of ≥ 150\u002FµL b. Adequate renal function is defined as: i. Creatinine clearance or radioisotope glomerular filtration rate ≥ 50 mL\u002Fmin\u002F1.73m2 c. Adequate liver function is defined as: i. Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for Gilbert's syndrome and ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN d. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the participant has been therapeutically anti-coagulated for previous venous thrombosis. e. Adequate pulmonary function, defined as no evidence of dyspnea at rest and pulse oximetry \\> 92% while breathing room air.\n\n     f. Adequate cardiac function, confirmed within the last 12 months, defined as: i. Left ventricular ejection fraction (LVEF) ≥ 40% by echocardiogram or multi-gated acquisition scanning (MUGA)\n  8. Must be willing to provide voluntary informed consent for study intervention.\n\nExclusion Criteria:\n\n* Exclusion Criteria for Cohort 1\n\n  1. Participant who has been treated with any investigational agents and chemotherapy targeting GBM \\\u003C= 4 weeks prior to date of study registration. Exceptions to this include: must be \\>=23 days from last dose of temozolomide (TMZ) or radiotherapy, mush be \\>= 6 weeks from last dose of nitrosourea.\n  2. Female participants of reproductive potential who are pregnant or lactating. Female study participants of reproductive potential must have a negative serum pregnancy test as part of eligibility confirmation.\n  3. Known addiction to alcohol or illicit drugs.\n  4. Prior treatment with any Epithelial Growth Factor Receptor (EGFR)-targeting therapy.\n  5. Participants with leptomeningeal dissemination.\n  6. Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or an autoimmune disorder requiring systemic cytotoxic or immunosuppressive therapy. Participants who are currently using non-systemic steroids (e.g., inhaled, intranasal, ocular, topical) are not excluded from the study.\n  7. Participants with serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B surface antigen (HBsAg+) will be excluded. Participants that are positive for hepatitis B core antibody or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. PCR positive participants will be excluded.\n  8. Participants who have received prior solid organ or bone marrow transplantation.\n  9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, second cancer currently receiving active treatment or anticipated to receive treatment within the next year, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  10. Participants who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.\n* Exclusion Criteria for Tissue Screening for Cohort 2\n\n  1\\. Participant is unwilling to undergo another surgery if felt clinically appropriate.\n* Exclusion Criteria for Study Enrollment for Cohort 2\n\n  1. Prior treatment with any EGFR-targeting therapy\n  2. Participant who has been treated with any investigational agents, chemotherapy, or biological therapy targeting GBM \\\u003C= 4 weeks prior to date of study registration. Exceptions to this include: no TMZ \\\u003C= 23 days or nitrosourea \\\u003C= 6 weeks prior to study enrollment. There is no washout prior to study enrollment for TTFields, but use of the device must be stopped at least 1 week prior to initiation of lymphodepleting (LD) chemotherapy.\n  3. Participants with imaging or clinical evidence of uncontrolled tumor mass effect; the assessment of mass effect will be made by the Investigators.\n  4. Participants with leptomeningeal dissemination.\n  5. Participants with a known disorder that affects their immune system, such as HIV or an autoimmune disorder requiring systemic cytotoxic or immunosuppressive therapy.\n\n     Participants who are currently using inhaled, intranasal, ocular, topical, or other non-oral or non-IV steroids are not necessarily excluded from the study.\n  6. Participants with serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B surface antigen (HBsAg+) will be excluded. Participants that are positive for hepatitis B core antibody or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. PCR positive participants will be excluded.\n  7. Participants who have received prior solid organ or bone marrow transplantation.\n  8. Female participants who are pregnant or breast-feeding.\n  9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, second cancer currently receiving active treatment or anticipated to receive treatment within the next year, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  10. Participants who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.",{"count":180,"type":22},[210],"PHASE1","This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so the CAR T cells will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine before treatment with CAR T cells may make the CAR T cells more effective.",[213,28,214,89],"EGFR Gene Mutation","MGMT-Unmethylated Glioblastoma",[60,216],"CAR T Therapy",{"date":163,"type":33},{"date":219,"type":33},"2024-04-30",{"date":221,"type":22},"2027-12-31",{"name":223,"class":40},"Hideho Okada, MD, PhD",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":41},"100528495","plx038-in-primary-central-nervous-system-tumors-containing-myc-or-mycn-amplifications-100528495","NCT06161519","PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications","Phase I\u002FII Trial of PLX038 in Primary Central Nervous System Tumors With and Without MYC or MYCN Amplifications","* INCLUSION CRITERIA:\n* Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:\n\n  * Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features.\n  * Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation.\n  * Cohort Phase IIB:\n\n    * Recurrent or progressive MYCN amplified ependymoma, OR\n    * Recurrent or progressive medulloblastoma with MYC or MYCN amplifications\n  * Cohort Phase IIC: Any other recurrent or progressive primary CNS tumor with MYC or MYCN amplifications.\n  * Cohort Phase IID: Any recurrent glioblastoma without MYC or MYCN amplifications.\n\nNOTE 1: Recurrence or progression may involve CNS, extra CNS, or both.\n\nNOTE 2: The presence of MYCN or MYC amplification must be confirmed by documented history. Participants who do not have documented history will be tested by NSR device (via next-generation sequencing panel TruSight(TM) Oncology 500) and the threshold of MYCN or MYC amplification for eligibility purposes is a fold change (FC) of \\>=2.5X (5 copies) with a minimum tumor content of 20%.\n\n* Participants must have archival tumor tissue (either a block or 15 formalin-fixed paraffin-embedded (FFPE) unstained slides) available for NCI LP review of MYC or MYCN amplification status (if necessary) and for correlative studies:\n\n  * Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID: tumor tissue obtained at any point before trial treatment initiation, but preferably from most recent surgical resection before study treatment initiation.\n  * Cohort Phase IIA: tumor tissue obtained at original diagnosis.\n* Participants in Cohort Phase IIA must have completed surgery followed by radiation at least 4 weeks and no more than 10 weeks from the last dose of radiation prior to study treatment initiation.\n* Participants in Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID must have completed prior cytotoxic chemotherapy or radiation at least 4 weeks prior to study treatment initiation (at least 6 weeks if the last regimen included lomustine (CCNU) or carmustine (BCNU); at least 3 weeks if the last regimen included bevacizumab; at least 4 weeks if the last regimen included a checkpoint inhibitor or any other type of immunotherapy or cellular therapy; at least 5 half-lives if the last regimen included any investigational agent(s).\n* Age \\>= 18 years.\n* Karnofsky \\>= 70%. NOTE: Participants with severe paraparesis\u002Fparaplegia who need minimal assistance for self-care due to their motor deficit but are otherwise functionally independent will be eligible.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>=3,000\u002Fmicroliter\n  * absolute neutrophil count \\>1,500\u002Fmicroliter\n  * platelets \\>100,000\u002Fmicroliter\n  * hemoglobin \\>= 9 g\u002F dL (may be transfused within 2 weeks prior to treatment to achieve this level)\n  * total bilirubin within normal institutional limits\n  * aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) \\\u003C2.5 X institutional upper limit of normal (ULN)\n  * creatinine within normal institutional limits OR\n  * estimated glomerular filtrate rate (eGFR) using chronic kidney disease epidemiology collaboration) (CKD-EPI) equation:\\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Women of child-bearing potential (WOCBP) and those who can father children must agree to use effective contraception (barrier, hormonal contraception, intrauterine device (IUD), surgical sterilization, barrier at the study entry, for the duration of study treatment and up to 6 months (WOCBP) and 3 months (those who can father children) after the last dose of study treatment.\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study drug.\n* Ability to self-report symptoms and physical function as determined by assessment of the clinical team performed at screening.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions to compounds of similar chemical composition to PLX038.\n* Major surgery within 2 weeks prior to study treatment initiation. NOTE: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges).\n* Participants who require treatment with strong inhibitors or inducers of CYP3A or with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038. Lists including medications and substances known or with the potential to interact with CYP3A or UGT1A1 are provided in https:\u002F\u002Fdrug-interactions.medicine.iu.edu\u002Fmaintable.\n* History of treatment with pegylated topoisomerase inhibitors.\n* Has unresolved or persistent grade 2 or higher GI toxicity from any type of RT at screening\n* Participants with history of homozygous for the UGT1A1\\*28 variant allele with severely reduced UGT1A1 activity.\n* Participants positive for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV).\n* Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening).\n* Participants unable to have MRIs.\n* Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (https:\u002F\u002Fdeainfo.nci.nih.gov\u002Fadvisory\u002Fctac\u002F1117\u002F4-JournalClinicalOncology.pdf, https:\u002F\u002Fctep.cancer.gov\u002FprotocolDevelopment\u002Fdocs\u002FCTEP\\_Broadened\\_Eligibility\\_Criteria\\_Guidance.pdf)\n* Uncontrolled intercurrent illness evaluated by history, weight, and physical exam that would limit compliance with study requirements.","120 Years",{"count":233,"type":22},146,[210,113],"Background:\n\nAbout 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years. Many of these people have changes in certain genes (MYC or MYCN) that drive the development of their cancers.\n\nObjective:\n\nTo test a study drug (PLX038) in people with tumors of the brain or spinal cord.\n\nEligibility:\n\nPeople aged 18 years or older with a tumor of the brain or spinal cord. Some participants must also have tumors with changes in the MYC or MYCN genes.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam and blood tests. They will have imaging scans and a test of their heart function. They may need to have a biopsy: A sample of tissue will be removed from their tumor.\n\nPLX038 is given through a tube attached to a needle inserted into a vein in the arm. All participants will receive PLX038 on the first day of each 21-day treatment cycle. They will take a second drug 3 days later to help reduce the risk of infection; for this drug, participants will be shown how to inject themselves under the skin at home.\n\nBlood tests, imaging scans, and other tests will be repeated during study visits. Hair samples will also be collected during these visits. Some participants may have an additional biopsy.\n\nStudy treatment will continue up to 7 months.\n\nFollow-up visits will continue every few months for up to 5 years.",[137,237,238,28],"Medulloblastoma","Ependymoma",[240,241,242,243,244],"Brain Tumors","Recurrent or progressive primary CNS tumors","Patient-Reported Outcomes","Spine Tumors","MYC or MYCN genes",{"date":246,"type":33},"2026-08-12",{"date":248,"type":33},"2024-01-31",{"date":250,"type":22},"2033-11-14",{"name":252,"class":253},"National Cancer Institute (NCI)","NIH",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":272,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":293},"100600687","phase-3-study-of-tlx101-tx-plus-standard-of-care-soc-versus-soc-alone-for-the-treatment-of-patients-with-recurrent-glioblastoma-100600687","NCT07100730","Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma","A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])","IPAX BrIGHT","Inclusion Criteria:\n\n1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.\n2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:\n\n   1. Any systemic antineoplastic treatment other than nitroureas\n   2. Tumor-treating fields\n   3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy\n3. Increased \\[18F\\]\\]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imaging using \\[18F\\]FET PET will be evaluated following co-registration with MRI. The allocated physician\u002Freader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.\n4. Tumor debulking for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased \\[18F\\] FET PET uptake and measurable disease according to PET RANO 1.0.\n5. 18 years or older\n6. Have the capacity to understand the study and be willing to comply with all protocol requirements.\n7. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70\n8. Patients on stable, not increasing dose of steroids in the previous 7 days can be included in the study\n9. Adequate hematological, liver and renal function at the time of screening.\n10. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational drug product; must not be breast-feeding; and must agree to use a highly effective method of contraception during treatment and for 6 months following last dose of investigational product.\n11. Male patients must agree to use condoms during sex during the treatment period and for 3 months after the last dose of the investigational drug product and must not make semen donations during treatment and for 6 months following last dose of investigational drug product. For male patients with female partners of childbearing potential, females must agree to use a highly effective method of contraception during the treatment period and for 6 months following last dose of investigational drug product.\n\nExclusion Criteria:\n\n1. Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.\n2. Treatment with bevacizumab within the prior 6 weeks.\n3. Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.\n4. History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).\n5. Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.\n6. Hemostaseologic conditions, precluding catheterization or invasive procedures.\n7. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.\n8. Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.\n9. Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.\n10. Ongoing toxicity \\> Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.\n11. Administration of another investigational product within 90 days prior to screening.\n12. Expected non-compliance with longer-term admission at isolated nuclear medicine ward per regional regulations.\n13. Inability to complete the needed investigational and standard imaging examinations due to any reason (ie, severe claustrophobia, inability to lie still for the entire imaging time).\n14. Patients with known phenylketonuria.\n15. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study investigator, would make the patient inappropriate for entry into the study.",{"count":263,"type":22},50,[53],"This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.",[267,28,268,269,270,271],"Neoplastic Disease","Glioblastoma (GBM)","Glioblastoma Multiform","Glioblastoma Multiforme, Adult","Glioblastoma Multiforme (GBM) WHO Grade IV",[273,274,275,276,277,278,28,62,279,280,281,282,283,284],"Lomustine","Radiation Therapy","Radiopharmaceuticals","Positron-Emission Tomography","Brain Neoplasms","Glioblastoma Multiforme","Neoplasm Recurrence, Local","Central Nervous System Neoplasms","Brain cancer","Recurrent brain tumor","Brain tumor recurrence","LAT-1 targeted therapy","2026-08-07",{"date":193,"type":33},{"date":288,"type":33},"2025-11-02",{"date":290,"type":22},"2027-11",{"name":292,"class":74},"Telix Pharmaceuticals (Innovations) Pty Limited",9,{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":41},"100651245","phase-2-levetiracetam-extended-release-plus-stupp-protocol-for-hypoxic-idh-wildtype-glioblastoma-100651245","NCT07758062","Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma","A Multicenter Prospective Cohort Study Evaluating Levetiracetam Extended-Release in Combination With Stupp Protocol for IDH-Wildtype Glioblastoma (ELITE)","ELITE","Inclusion Criteria:\n\n* Age ≥18 and \\\u003C70 years. Histopathologically confirmed primary IDH-wildtype glioblastoma (WHO CNS Grade 4, 2021 WHO Classification).\n\nTumor with hypoxic features confirmed by immunohistochemistry (HIF-1α and CA9 expression score ≥2).\n\nPlanned to receive standard Stupp protocol after maximal safe surgical resection.\n\nKarnofsky Performance Status (KPS) ≥70.\n\nAdequate bone marrow function:\n\nHemoglobin ≥90 g\u002FL Platelet count ≥100 × 10⁹\u002FL White blood cell count ≥3.0 × 10⁹\u002FL Absolute neutrophil count ≥1.5 × 10⁹\u002FL\n\nAdequate hepatic function:\n\nAST and ALT ≤2.5 × upper limit of normal (ULN) Total bilirubin \\\u003C50 μmol\u002FL.\n\nAdequate renal function:\n\nSerum creatinine ≤1.5 × ULN Creatinine clearance (CrCl) ≥36 mL\u002Fmin. No previous chemotherapy, radiotherapy, immunotherapy, or targeted therapy for glioblastoma.\n\nNo history of epilepsy or prior antiepileptic drug treatment. Ability to understand the study procedures and provide written informed consent.\n\nWilling and able to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Known hypersensitivity to levetiracetam, pyrrolidone derivatives, or any study drug component.\n\nHistory of epilepsy or previous treatment with antiepileptic drugs. Requirement for concomitant use of other antiepileptic drugs during the study. Presence of another active malignancy. Severe cardiac, hepatic, renal, hematologic, or other uncontrolled systemic diseases.\n\nUncontrolled metabolic disorders or severe infections. Active hepatitis B, hepatitis C, HIV infection, active syphilis, or active tuberculosis.\n\nParticipation in another interventional clinical trial within 4 weeks before screening.\n\nHistory of organ transplantation or hematopoietic stem cell transplantation. Pregnancy or breastfeeding, or plans for pregnancy during the study period. Psychiatric illness, cognitive impairment, or poor compliance that would interfere with study participation.\n\nAny other condition that, in the investigator's judgment, would make participation unsafe or interfere with study evaluation.","69 Years",{"count":304,"type":22},140,[113],"Glioblastoma (GBM) is the most common primary malignant brain tumor in adults and is associated with poor prognosis despite standard treatment with maximal safe resection followed by radiotherapy plus temozolomide (the Stupp regimen). Tumor hypoxia is associated with treatment resistance and poor clinical outcomes. This multicenter, prospective, controlled study aims to evaluate whether levetiracetam extended-release combined with the Stupp regimen improves progression-free survival and overall survival in patients with hypoxic IDH-wildtype glioblastoma while maintaining an acceptable safety profile. Eligible patients with newly diagnosed hypoxic IDH-wildtype glioblastoma will receive either levetiracetam extended-release plus the Stupp regimen or the standard Stupp regimen. Clinical efficacy, safety, and quality-of-life outcomes will be evaluated during follow-up.",[28],[28,309,310,311,312,313,314,315],"IDH-Wildtype","Hypoxia","Levetiracetam","Stupp Regimen","Temozolomide","Progression-Free Survival","HIF-1α","2026-08-06",{"date":193,"type":33},{"date":319,"type":22},"2026-09-01",{"date":321,"type":22},"2029-09-01",{"name":323,"class":40},"Tianjin Medical University General Hospital",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100607979","beginning-radiation-immediately-with-gammatile-at-gbm-excision-versus-standard-of-care-100607979","NCT07195591","Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care","Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)","BRIDGES","Major Criteria Includes the Following:\n\nInclusion Criteria\n\n* Patients must be ≥18 years of age.\n* Have radiographic suspicion of newly diagnosed glioblastoma (GBM).\n\n  o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.\n* Are medically and surgically appropriate for resection.\n* Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.\n* Are able to receive standard of care treatment.\n\nExclusion Criteria\n\n* A previous biopsy diagnosis other than IDH wild-type GBM.\n* Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.\n* Have multi-focal enhancing tumors that cannot be encompassed in one operative field.",{"count":333,"type":22},766,[53],"This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:\n\n* A Screening\u002FBaseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.\n* A Perioperative\u002FOperative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).\n* An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase.\n* An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg\u002Fm2\u002Fday orally for each Arm.\n* An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg\u002Fm2\u002Fday orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator.\n* An Early Discontinuation\u002FFollow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days.\n\nFor any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.",[28],[28,338,339,340,313,341,342,343,274,344,345,62,330,346,347],"Newly Diagnosed","GammaTile","External Beam Radiation Therapy","Brain","Tumor","Brachytherapy","Surgery","Resection","EBRT","TMZ",{"date":349,"type":33},"2026-08-10",{"date":351,"type":33},"2025-12-10",{"date":353,"type":22},"2031-12",{"name":355,"class":74},"GT Medical Technologies, Inc.",7,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":181,"phases":4,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":41},"100606305","a-study-to-better-understand-the-biological-and-molecular-mechanisms-involved-in-glioblastoma-recurrence-and-progression-100606305","NCT07173829","A Study to Better Understand the Biological and Molecular Mechanisms Involved in Glioblastoma Recurrence and Progression","A Prospective Study to Better Understand the Molecular, Immune and Metabolic Mechanisms Involved in Glioblastoma Recurrence and Progression, in the Aim to Identify New Therapeutic Targets and to Improve Current Therapies","BORDEAUX-GLIO","Inclusion Criteria:\n\n* Patients of 18 years or older, with highly suspected glioblastoma on neuro-imagery\n* Planned surgical tumor resection,\n* No objection to participate in research\n* Signed genetic consent\n\nExclusion Criteria:\n\n* Patients under guardianship, curatorship or protective supervision\n* Taking immunosuppressants\n* Pregnant or breast-feeding women\n* Patients deprived of their liberty by judicial or administrative decision, or under psychiatric care",{"count":366,"type":22},45,"BORDEAUX-GLIO is a prospective, monocentric study which will describe the molecular, immune and metabolic pathways involved in the progression and relapse of glioblastoma, using blood and tumor samples from patients who have undergone surgery for newly diagnosed or recurrent glioblastoma in the center.",[28],[370,371,372,373,374,375,376,377,60,378],"Glioblastoma progression","Glioblastoma recurrence","Metabolism","Lactate","Metabolomic","Transcriptomic","Radiation therapy","Radiosensitizer","γδ T lymphocytes","2026-08-04",{"date":285,"type":33},{"date":382,"type":33},"2025-10-22",{"date":384,"type":22},"2031-10",{"name":386,"class":40},"University Hospital, Bordeaux",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":41},"100593215","phase-2-a-phase-2-and-pharmacodynamic-study-of-sitagliptin-in-patients-with-progressive-grade-4-gliomas-100593215","NCT07003542","A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas","Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma) for whom a clinically-indicated tumor resection is planned.\n2. Participants must not have received sitagliptin or other gliptins.\n3. Participants must, in the opinion of the investigator be able to tolerate a pre-operative dexamethasone dose of 4 mg\u002Fd or the equivalent dose of an alternate glucocorticoid.\n4. Age \\>18 years\n5. Karnofsky performance status ≥ 60%\n6. Participants must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:\n\n   * Hemoglobin ≥ 9 g\u002Fdl\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelet count ≥ 100,000\u002FmcL\n   * Total bilirubin \\\u003C 1.5x institutional upper limit of normal (ULN)\n   * AST (SGOT) ≤ 3x institutional ULN\n   * ALT (SGPT) ≤ 3x institutional ULN\n   * Calculated creatinine clearance \\> 50 mL\u002Fmin or creatinine \\\u003C 1.5x institutional upper limit of normal (ULN)\n   * Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) \\\u003C 1.4 for participants not on warfarin.\n7. Participants on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:\n\n   * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\n   * In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin.\n8. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry. Women of childbearing potential and men 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 through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while taking part in this study, she should inform her treating physician immediately. Men of reproductive potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n9. Participants must be able to swallow whole tablets.\n10. Participants must have the following minimum intervals from prior treatments:\n\n    * surgery - 4 weeks\n    * nitrosoureas - 6 weeks\n    * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. E.g., for temozolomide 23 days after most recent dose.\n    * For drugs not listed, the research nurse, treating investigator, and principal investigator will decide on the appropriate interval.\n    * Investigational therapy or non-cytotoxic therapy - 2 weeks.\n    * For bevacizumab - 4 weeks from expected date of protocol surgery\n11. Participants positive for human immunodeficiency virus (HIV) are allowed on study (note: HIV testing is not required), but HIV-positive participants must have:\n\n    * An undetectable viral load within 6 months of registration.\n    * A stable regimen of highly active anti-retroviral therapy (HAART)\n    * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n12. For participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Note: Known positive test for HCV ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy.\n13. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\n    Note: A known positive test for HBV surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Participants who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g., participants immunized against hepatitis B)\n14. Patient must be deemed by investigator to be a candidate for post-operative chemotherapy.\n15. Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\n    Exclusion Criteria:\n16. Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.\n17. Participants receiving any other investigational agents.\n18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin.\n19. Participants with uncontrolled diabetes mellitus\n20. Participants who require insulin therapy or a sulfonylurea\n21. Participants with documented history of hypoglycemia requiring medical intervention or who in the opinion of the investigator are not suitable to receive sitagliptin.\n22. Participants with 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 would limit compliance with study requirements.\n23. Other prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded. Otherwise, participants with prior or concurrent malignancy are eligible.\n24. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology at screening) (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE v.5.0\\]).\n25. Pregnant or breastfeeding.\n26. Unable or unwilling to swallow tablets.\n27. Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness\u002Fsocial situations that would, in the investigator's judgment, make the patient inappropriate for this study.",{"count":395,"type":22},48,[113],"The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting specific immune cells called myeloid-derived suppressor cells (MDSCs) that suppress your body's natural immune response against cancer.\n\nSitagliptin is an investigational drug for this condition that works by inhibiting an enzyme called dipeptidyl peptidase 4 (DPP-4), which MDSCs rely on to enter the brain and function. While sitagliptin is FDA-approved for diabetes treatment, its use in glioblastoma is investigational (experimental).",[28,399],"Brain Tumor",[401],"Myeloid-derived suppressor cells",{"date":316,"type":33},{"date":404,"type":33},"2026-03-16",{"date":406,"type":22},"2028-06",{"name":408,"class":40},"Case Comprehensive Cancer Center",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":41},"100482675","phase-1-prospective-surgical-study-on-the-pattern-of-electrical-activity-in-high-grade-glioma-as-a-predictor-of-progression-100482675","NCT05565118","Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression","Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma (WHO Grade III and IV) as a Predictor of Progression","Inclusion Criteria:\n\n* Participants who have the appearance of high-grade glioma (HGG, WHO Grade 3 and 4, including GBM) on MR imaging are allowed to consent and will undergo the procedure if the frozen is consistent with HGG\n\nOR\n\n* Participants with a history of histologically-confirmed diagnosis of high- grade glioma that are undergoing resection of a recurrent\u002Fprogressive tumor that is likely recurrent\u002Fprogressive high- grade glioma as identified on preoperative MR imaging\n* Age ≥ 18 years old\n* Volumetric MRI within 1 month prior to surgery\n* Karnofsky performance status of 60 or higher\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Participants must be considered appropriate neurosurgical candidates with the following screening\u002Fbaseline laboratory values within 1 month prior to surgery:\n\n  * Absolute neutrophil count ≥ 1500\u002FµL\n  * Platelets ≥ 100 000\u002FµL\n  * International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × Upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * Urine or Serum Pregnancy Test = Negative (Not applicable to participants with bilateral oophorectomy and\u002For hysterectomy or to those participants who are postmenopausal).\n\nExclusion Criteria:\n\n* Severe co-morbidity that would confer excess risk of surgery as determined by the treating physician.\n* Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.\n* Is pregnant\n* Coagulopathy or platelet dysfunction that increases the risk of intra and postoperative hemorrhage\n* Tumor location requiring DE placement\u002Fbiopsy in eloquent or critical region of the brain (e.g. primary motor and sensory cortices, speech and vision centers, thalamus, basal ganglia, cerebellum, brain stem) as deemed by the neurosurgeon designing the surgical plan",{"count":417,"type":22},10,[210],"The purpose of this study is to test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings.",[421,28],"High Grade Glioma",[421,28,423,424],"Neural Recording","Electrical Activity",{"date":316,"type":33},{"date":427,"type":33},"2024-04-09",{"date":429,"type":22},"2026-12",{"name":408,"class":40},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":4,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":437,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":443,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":447,"locationsCount":4},"100650443","nuvox-expanded-access-100650443","NCT07748299","NuvOx Expanded Access","* Inclusion Criteria:\n\n  1. Patients must have a condition that is serious or immediately life-threatening.\n  2. Patients must have exhausted other treatment options or are ineligible to participate in ongoing clinical trials.\n  3. The potential benefits of treatment with NanO₂ must outweigh the potential risks, as determined at the discretion of the treating physician and NuvOx.\n* Exclusion criteria:\n\n  1. Providing NanO₂ for the requested use will interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the use.\n\n     * A request will be evaluated against the criteria of 21 CFR 312.305(a) and 312.310(a).\n\n       * NuvOx will consider the totality of available information, including applicable nonclinical and clinical experience, the patient's condition, and the treating physician's rationale for use.","EXPANDED_ACCESS","NanO₂ is an investigational drug being studied by NuvOx Therapeutics. It has not been approved by the U.S. Food and Drug Administration (FDA) for any use. This record describes a way for a patient's own doctor to request NanO₂ for that patient outside of a clinical trial, through a pathway called \"expanded access\" (sometimes called \"compassionate use\").\n\nThis option may be considered for patients who have a serious or life-threatening illness, who have already tried other available treatments, and who cannot join an ongoing NanO₂ clinical trial. NuvOx's RESTORE study in glioblastoma has finished enrolling patients, and NuvOx does not currently have any other NanO₂ study open for enrollment in the United States.\n\nUnder this pathway, the patient's treating physician - not NuvOx - applies to the FDA and manages the patient's care. NuvOx's role is to review each request, and if approved, provide the drug and the regulatory information the FDA needs to evaluate it. Each request is reviewed individually, and approval is not guaranteed.",[28,440,441,442],"Respiratory Distress Syndrom","Ischemic Stroke","Hypoxic Conditions","AVAILABLE","2026-08-03",{"date":446,"type":33},"2026-08-05",{"name":448,"class":74},"NuvOx LLC",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":473},"100335140","phase-1-bortezomib-and-temozolomide-in-recurrent-grade-4-glioma-unmethylated-mgmt-promoter-bortem-17-100335140","NCT03643549","Bortezomib and Temozolomide in Recurrent Grade-4 Glioma Unmethylated MGMT Promoter (BORTEM-17)","Bortezomib Sensitization of Recurrent Grade-4 Glioma With Unmethylated MGMT Promoter to Temozolomide Phase 1B\u002FII Study","BORTEM-17","Inclusion Criteria:\n\n* Life expectancy \\> 8 weeks\n* Histologically confirmed intracranial glioblastoma (GBM), with MGMT unmethylated promoter\n* Must submit an unstained paraffin block and\u002F or cryopreserved tumour tissue from surgical procedure\n* Radiologically (MRI) confirmed tumour relapse\u002Fprogression ≥ 12 weeks since completed radiotherapy\n* Measurable recurrent tumor\n* Tumor not available for radio-surgery\n* If previously treated with gammaknife, at least one evaluable lesion outside the irradiated area is required, unless the time after the radiosurgery is 12 weeks or more\n* Written informed consent for study participation and tumour, blood sample collection obtained before performance of any study related procedure.\n* Karnofsky performance status ≥ 70\n* WBC ≥ 3,000\u002Fmm\\^3\n* ANC ≥ 1,500\u002Fmm\\^3\n* Platelet count ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 10 g\u002FdL (transfusion allowed)\n* Bilirubin \\\u003C 2.5 times upper limit of normal (ULN)\n* serum aspartate aminotransferase (AST) \\\u003C 2.5 times ULN\n* Estimated GFR ≥ 60 mL\u002Fminute\n* Serum sodium \\> 130 mmol\u002FL\n* Serum potassium level within normal limit\n* Stable or reduced doses of corticosteroids for at least 1 week prior to enrolment\n* Negative pregnancy test no longer than 14 days prior to enrollment\n* Fertile patients and female partners with child bearing potential of male patients must use adequate contraception\n* Patients on EIAED must be transitioned to non-EAIED for ≥ 2 weeks\n* Unfractionated and\u002For low molecular weight heparin allowed\n* Patients previously treated with neurosurgery er eligible for the study\n\nExclusion Criteria:\n\n* Hypersensitivity to Bortezomib, boron, or mannitol\n* Any contraindications for use of temozolomide\n* Peripheral neuropathy ≥ grade 2\n* Previous treatment with bevacizumab or lomustine alone or as a combination therapy for ralapsed glioblastoma (PCV as primary treatment of low grade glioma, before development of glioblastoma, is allowed)\n* Myocardial infarction within the past 6 months\n* NYHA class III or IV heart failure\n* Uncontrolled angina\n* Severe uncontrolled ventricular arrhythmias\n* Electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n* Known heart failure\n* Serious medical or psychiatric illness that would interfere with the study participation including, but not limited to, any of the following:\n* Ongoing or active infection requiring IV antibiotics\n* Psychiatric illness and\u002For social situations that would limit compliance with study requirements\n* Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus)\n* History of stroke within the past 6 months\n* Other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy\n* Significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy\n* Disease that will obscure toxicity or dangerously alter the drug metabolism\n* Viral hepatitis (HBV surface antigen positive) or active hepatitis C infection\n* Other investigational drugs must be stopped at least 12 weeks prior to therapy or treatment failure under other experimental therapy must be confirmed before study entry. If progression during other experimental therapy is confirmed, the time interval between previous treatment and BORTEM-17 may be reduced to 4 weeks\n* Concurrent inducers of CYP450 3A4 (e.g., enzyme-inducing anti-epileptic drugs \\[EIAED\\])",{"count":458,"type":22},63,[210,113],"This phase IB\u002FII trial is designed to investigate the safety and survival benefits for patients with recurrent grade-4 with unmethylated MGMT promoter treated with Bortezomib and Temozolomide in a specific schedule.",[28],[313,463,464],"Bortezomib","Recurrent disease","2026-08-02",{"date":379,"type":33},{"date":468,"type":33},"2018-08-30",{"date":470,"type":22},"2026-12-31",{"name":472,"class":40},"Haukeland University Hospital",2,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":498},"100628690","phase-1-a-phase-1-safety-and-dose-finding-study-of-glix1-in-adults-with-recurrent-or-progressive-high-grade-glioma-100628690","NCT07464925","A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","Main Inclusion Criteria:\n\n* Adult patients aged ≥18 years at the time of informed consent\n* Participants must have histologically confirmed Grade 3 or Grade 4 glioma\n* Recurrent or progressive disease\n* A maximum of two prior treatment lines\n* Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field.\n* Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:\n\n  * for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)\n  * for monoclonal antibodies: 42 days (6 weeks)\n  * for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)\n* Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n* Ability to swallow tablets or capsules.\n* Adequate hematological, liver and renal function.\n* Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index \\\u003C1%) for the duration of the study and for at least 3 months after the last dose of study medication.\n* Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.\n\nMain Exclusion Criteria:\n\n* Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI\n* Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and\u002For bisphosphonates or denosumab.\n* Participants with known active or uncontrolled infection, and\u002For unexplained fever \\>38°C in the 3 days prior to the start of study treatment.\n* Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent.\n* Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.",{"count":21,"type":22},[210],"This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.\n\nPatients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.",[485,137,28],"Glioblastoma Multiforme of Brain",[487,137,62,28,488],"GLIX1","TET2","2026-07-29",{"date":491,"type":33},"2026-07-30",{"date":493,"type":33},"2026-04-20",{"date":495,"type":22},"2027-12",{"name":497,"class":74},"Tetragon Biosciences Ltd",3,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":473},"100592259","phase-2-ruxolitinib-with-radiation-and-temozolomide-compared-to-radiation-and-temozolomide-for-newly-diagnosed-glioblastoma-100592259","NCT06991101","Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma","Randomized Phase 2 Trial of Ruxolitinib in Combination With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma.","Inclusion Criteria:\n\n1. Provision of signed informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.\n4. Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated, unmethylated, or indeterminate MGMT.\n5. Confirmation that patient has sufficient tissue to undergo MGMT and IDH testing, as mandated.\n6. Must have a Karnofsky performance status (KPS) ≥ 70% (i.e., the patient must be able to care for themself with occasional help from others).\n7. Adequate organ (liver and renal) and bone marrow function within 14 days before randomization. For all parameters listed below, the most recent results available must be used:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.\n   2. Platelet count ≥ 100,000\u002Fmm3. Note: Platelet transfusion is not allowed within 1 week prior to registration.\n   3. Total bilirubin (TBL) ≤ 1.5 × institutional upper limit of normal (ULN).\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n   5. Serum albumin ≥ 2.5 g\u002FdL.\n8. Patients able to become pregnant: use of highly effective contraception for at least one (1) month prior to screening and agreement to use such a method. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Such individuals must have a negative pregnancy test.\n9. Patients must have no concurrent malignancy except curatively treated early-stage bladder and prostate cancer that has been completed resected, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ 3 years.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.\n2. Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).\n3. Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study.\n4. Patients who have had repeat craniotomy for tumor therapy after receiving radiation therapy and temozolomide treatment.\n5. Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment.\n6. Patient has previously taken ruxolitinib or is allergic to components of the study drug.\n7. Patients using warfarin.\n8. Uncontrolled immunodeficiency virus infection or active tuberculosis.\n9. Patients with active serious infections requiring systemic therapy.\n10. Known Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Participants with previous positive serology results must have negative polymerase chain reaction results.\n11. Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, New York Heart Association (NYHA) Grade ≥2 heart failure, uncontrolled hypertension, valvular disease, pericarditis, myocardial infarction, or other thrombosis events like including pulmonary embolism or deep vein thrombosis within 6 months of screening.\n12. Any other serious medical\u002Fpsychiatric condition, in the judgement of the investigator, that likely to interfere or limit compliance with study requirements\u002Ftreatment.",{"count":507,"type":22},190,[113],"The purpose of this research is to test the safety and effectiveness of the investigational drug ruxolitinib when it is combined with standard of care treatment (radiation therapy and temozolomide) for the treatment of newly diagnosed glioblastoma. Half the people in the study will be assigned to take the study drug ruxolitinib in addition to the standard of care temozolomide and radiation therapy and the other half will be assigned to the standard of care temozolomide and radiation therapy only. This assignment will be randomized in a 1-to-1 ratio, like the flip of a coin.",[28,511,278,485,270,214,512],"Brain Cancer","MGMT-Methylated Glioblastoma",{"date":491,"type":33},{"date":515,"type":33},"2025-12-03",{"date":517,"type":22},"2030-12",{"name":519,"class":40},"Baptist Health South Florida",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":458},"100360233","phase-2-a-trial-to-evaluate-multiple-regimens-in-newly-diagnosed-and-recurrent-glioblastoma-100360233","NCT03970447","A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma","GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II\u002FIII Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM","GBM AGILE","Newly Diagnosed Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.\n* Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from definitive surgery or biopsy.\n\nRecurrent Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).\n* Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.\n* Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.\n* Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from initial definitive surgery and\u002For, recurrent surgery, if performed.\n\nNewly Diagnosed Exclusion Criteria:\n\n* Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\\u003C 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.\n\nRecurrent Exclusion Criteria:\n\n* Early disease progression prior to 3 months (12 weeks) from the completion of RT.\n* More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)\n* Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.\n* Any prior treatment with prolifeprospan 20 with carmustine wafer.\n* Any prior treatment with an intracerebral agent.\n* Receiving additional, concurrent, active therapy for GBM outside of the trial\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\\u003C 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.",{"count":529,"type":22},2250,[113,53],"Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II\u002FIII response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.\n\nAll institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\\*).",[28],[28,534,535,536,537,538,539,540,541,542,543,544],"Newly diagnosed","recurrent","O6-methylguanine-DNA-methyltransferase (MGMT) methylated","MGMT unmethylated","isocitrate dehydrogenase (IDH) wild-type","Bayesian","adaptive randomization","Master Protocol","Platform Trial","Phase 2","Phase 3",{"date":491,"type":33},{"date":547,"type":33},"2019-07-30",{"date":549,"type":22},"2030-06",{"name":551,"class":40},"Global Coalition for Adaptive Research",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":41},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":560,"type":22},27,[113],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[564,565,566,567,568,569,570,571,572,573,28,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Melanoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-07-28",{"date":491,"type":33},{"date":595,"type":33},"2025-12-18",{"date":597,"type":22},"2026-12-18",{"name":146,"class":40},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":41},"100649168","characterization-of-the-blood-brain-barrier-in-high-grade-glioma-through-immunohistochemical-transcriptional-fluorescein-and-radiological-analyses-100649168","NCT07731555","Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Newly diagnosed glioblastoma.\n* Selected for surgical tumor resection.\n* Able and willing to provide written informed consent.\n* Able to undergo study assessments and follow-up procedures.\n\nExclusion Criteria:\n\n* Contraindication to magnetic resonance imaging.\n* Confusion, delirium, or altered state of consciousness that interferes with the ability to provide informed consent.\n* Any condition that, in the opinion of the investigator, would prevent completion of study procedures or compromise participant safety.",{"count":133,"type":22},[25],"This prospective study aims to characterize blood brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma multiforme undergoing surgical resection. The study integrates advanced MRI, circulating BBB biomarkers, neurocognitive assessment, and molecular analysis of tumor tissue to investigate relationships between BBB integrity, tumor biology, and neurological function. Participants will undergo serial assessments before surgery, after surgery, and following radiotherapy. Tumor tissue collected during standard-of-care resection will undergo immunohistochemical and transcriptional",[28],[610,28,421],"Blood Brain Barrier","2026-07-25",{"date":592,"type":33},{"date":614,"type":33},"2022-03-01",{"date":616,"type":22},"2035-12-31",{"name":618,"class":40},"Patrick Morris",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":41},"100649674","phase-2-positron-emission-tomographycomputed-tomography-petct-imaging-in-patients-diagnosed-with-a-glioma-100649674","NCT07735819","Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) Imaging in Patients Diagnosed With a Glioma","Tryptophan-kynurenine Pathway PET Imaging in Human Gliomas","FOR ARMS 1-3\n\nInclusion Criteria:\n\n* Age =18 years.\n* Patient is able to lie in the PET\u002FCT scanner for at least 60 minutes while undergoing scanning.\n* Patient is willing and able to review, understand, and provide written consent for the study procedures and indicates that they are aware of the investigational nature of this study.\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating are excluded. Premenopausal women (defined per institutional guidelines) must have a negative pregnancy test (urine or serum) within 7 days of the PET scan.\n* Severe increased intracranial pressure, status epilepticus, or other severe or progressing clinical symptoms requiring urgent intervention in the opinion of the treating\n* Karnofsky performance score \\\u003C60, as determined by one of the clinician co- investigators.\n\nADDITIONAL CRITERIA FOR ARM 1:\n\nInclusion Criteria:\n\n* Histopathology\u002Fcytopathological diagnosis of a glioblastoma without a history of radiation.\n* The tumor is deemed amenable for radiation treatment (pre-radiation planning MRI can be done before or after the PET scan).\n\nADDITIONAL CRITERIA FOR ARM 2:\n\nInclusion Criteria:\n\n* Previous histopathology\u002Fcytopathological diagnosis of glioblastoma.\n* History of glioma radiation.\n* Presence of a new or progressing enhancing brain lesion on follow-up clinical MRI suspicious for post-radiation glioma progression or late radiation-induced MRI changes (i.e., radiation injury), at least 7 mm in bidirectional diameter.\n* The most recent MRI, used for comparison with the PET\u002FCT, is performed within 4 weeks of the planned PET scan.\n\nADDITIONAL CRITERIA FOR ARM 3\n\nInclusion Criteria:\n\n* MRI diagnosis of a brain tumor, previously verified to be a low-grade (WHO grade 2, IDH (isocitrate dehydrogenase) mutant glioma, based on histopathology from biopsy or resection.\n* The detected mass on the most recent clinical MRI is at least 7 mm in bidirectional diameter (i.e., twice the PET scanner resolution).\n* The tumor does not require urgent (within 1 month) resection, steroid treatment, or radiation.\n* The most recent MRI, used for comparison with the PET\u002FCT, is performed within 4 weeks.\n* Patient agrees to have a baseline and follow-up PET\u002FCT scan (approximately 1 month later) and interval oral treatment with 200mg\u002Fday minocycline.\n* Due to planned minocycline treatment, patients will need to have adequate renal function\n\nExclusion Criteria:\n\n* Active connective tissue disorders, such as lupus or scleroderma.\n* History of allergic reaction to minocycline or any tetracyclines.\n* Ongoing treatment with warfarin with INR \\> 1.5.\n* History of colitis during antibiotics treatment.",{"count":627,"type":22},61,[113],"The goal of this clinical trial is to evaluate Positron emission tomography\u002Fcomputed tomography (PET\u002FCT) imaging with the radiotracer 1-(2-\\[18F\\]fluoroethyl)-l-tryptophan (\\[18F\\]FETrp) in patients diagnosed with a glioma. This study has 3 aims:\n\n* to assess if the \\[18F\\]FETrp PET\u002FCT can outperform Magnetic Resonance Imaging (MRI) by providing a better treatment target volume in newly diagnosed Stage 4 glioma patients\n* better differentiate tumor progression from radiation induced MRI changes in post treatment stage 4 gliomas\n* by giving a drug that can inhibit a pathway to allow objective assessment of treatment effects in low grade gliomas",[631,28],"Low Grade Glioma","2026-07-24",{"date":491,"type":33},{"date":635,"type":22},"2026-09",{"date":637,"type":22},"2031-06-30",{"name":639,"class":40},"Barbara Ann Karmanos Cancer Institute",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":23,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":473},"100567775","phase-1-a-phase-iii-study-of-ivonescimab-in-recurrent-glioblastoma-100567775","NCT06672575","A Phase I\u002FII Study of IVONESCIMAB in Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Karnofsky Performance Status (KPS) of 60 or greater\n3. Recurrent supratentorial Glioblastoma that has progressed following standard therapy; patients must have previously been treated with radiation with or without temozolomide.\n\n   1. Patients will be eligible at first or second recurrence.\n   2. Patients must be greater than 12 weeks from completion of initial chemoradiation at the time of progression, with the exception that patients with biopsy-confirmed recurrent disease prior to this time window can be enrolled.\n4. Diagnosis of Glioblastoma IDH-wildtype, WHO Grade 4 consistent with WHO CNS 2021 criteria. This will include patients with a diagnosis of molecular glioblastoma.\n5. Measurable or evaluable disease per RANO criteria\n6. A baseline MRI Brain no more than 14 days prior to study enrollment\n7. Adequate Organ Function, with screening labs performed within 14 days of treatment initiation:\n\n   a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL ii. Platelet count ≥ 100 × 109\u002FL iii. Hemoglobin ≥ 9.0 g\u002FdL b. Kidneys: i. Creatinine clearance\\* (CrCL) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR)\n\n   CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).\n\n   ii. Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g or Urine protein\u002FCreatinine ratio ≤ 1mg\u002Fmg (≤ 113.2mg\u002Fmmol) c. Liver: i. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN d. Coagulation: prothrombin time (PT) or international normalized ratio (INR)\n   * 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy or prophylactic coagulation)\n8. Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n9. Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab.\n10. Male patients of childbearing potential having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 90 after the last dose of ivonescimab.\n11. Ability to understand and willingness to sign informed consent form prior to the initiation of study and any study procedures.\n\n    1. Participants with cognitive impairment may be enrolled. The formal consent for such participants will be obtained from their legally authorized representative. However, participants will be informed about the research to the maximum extent compatible with their understanding. Assent will be obtained from such participants who will sign and date the consent form if capable.\n    2. Non-English speakers are allowed to enroll provided consent and all visits will be conducted with a medical interpreter.\n\nExclusion Criteria:\n\n1. Major surgical procedures or serious trauma, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator).\n\n   Minor local procedures (excluding central venous catheterization and port implantation).\n2. Currently pregnant or breastfeeding.\n3. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms, including but not limited to:\n\n   a. Significant intracranial hemorrhage\n   1. Note: Patients with clinically asymptomatic presence of hemosiderin, resolving postoperative changes or punctate intratumoral hemorrhage are permitted\n   2. Gastrointestinal bleeding\n\n   b. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed. c. Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed) d. Need for therapeutic anticoagulant therapy Note: Prophylactic anticoagulation for DVT\u002FPE or to maintain venous patency is allowed.\n4. Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n5. Is receiving dexamethasone \\>2mg daily, or the corticosteroid equivalent thereof.\n6. History of major diseases, specifically:\n\n   1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture), or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n   2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding\n   3. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy\n   4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks beforerandomization\n   5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection)\n7. History of other malignancy diagnosed or requiring treatment within the past 3 years prior to enrolment, with the exception of those with negligible expected risk of metastasis or death (including adequately treated non- melanoma skin cancer or cervical carcinoma in situ).\n8. History of prior treatment of GB with anti-VEGF and\u002For anti-PD-1\u002FPDL-1 agents, including monotherapy with either category or combinations thereof.\n9. Has received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced deliver. Prior treatment with Gliadel ® wafers will be excluded. Concurrent use of devices such as Tumor Treating Fields is not permitted.\n10. Has known leptomeningeal disease, gliomatosis cerebri, extracranial disease, or multicentric disease (regionally multifocal enhancing disease with continguous T2\u002FFLAIR is permitted to be enrolled)\n11. Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the treating physician and PI\n12. History of clinically significant autoimmune disease including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjogren's syndrome, GuillainBarré syndrome, multiple sclerosis, vasculitis or glomerulonephritis\n\n    1. Patients with a history of autoimmune hypothyroidism may be eligible if on a stable dose of thyroid replacement hormone\n    2. Patients with controlled Type 1 diabetes mellitus may be eligible if on a stable insulin regimen\n    3. Patients with dermatologic disorders (e.g., eczema) may be eligible if well controlled at baseline and not requiring systemic treatment or other treatments beyond low potency topical steroids\n13. Has contraindication for undergoing MRI scans or receiving MRI contrast.\n14. History of stroke or TIA within 6 months prior to study enrolment.\n15. Imaging during the screening period shows that the patient has:\n\n    1. Radiologically documented evidence of major blood vessel invasion or encasement by cancer\n    2. Radiographic evidence of intratumor cavitation",{"count":366,"type":22},[210,113],"The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and the recommended Phase 2 dose of ivonescimab that can be given to patients who have recurrent glioblastoma.\n\nThe goal of Phase 2 of this clinical research study is to learn if the recommended Phase 2 dose of ivonescimab found in Phase 1 can help to control the disease.",[28],"2026-07-20",{"date":652,"type":33},"2026-07-21",{"date":654,"type":33},"2025-01-30",{"date":656,"type":22},"2030-01-31",{"name":658,"class":40},"M.D. Anderson Cancer Center",{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":23,"phases":668,"briefSummary":669,"conditions":670,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":41},"100399323","customized-neuro-imaging-referenced-symptom-video-for-the-reduction-of-patient-and-caregiver-anxiety-around-radiation-treatment-for-brain-tumors-100399323","NCT04479696","Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors","Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video","Inclusion Criteria:\n\n* PATIENT ELIGIBILITY CRITERIA: Adult patients with newly diagnosed glioma (World Health Organization \\[WHO\\] grade 2-4) who are planned for a 6-week course of radiotherapy after surgery\n* PATIENT ELIGIBILITY CRITERIA: Able to complete questionnaires in English\n* PATIENT ELIGIBILITY CRITERIA: Has a post-operative diagnostic magnetic resonance imaging (MRI) of the brain with and without contrast acquired within 4 weeks of the start of radiotherapy\n* CAREGIVER ELIGIBILITY CRITERIA: Adult caregiver (\\>= 18 years) who is accompanying an eligible patient consented to the study\n* CAREGIVER ELIGIBILITY CRITERIA: The patient who the caregiver is accompanying is consented for participation on the study\n* CAREGIVER ELIGIBILITY CRITERIA: Able and willing to complete questionnaires in English\n\nExclusion Criteria:\n\n* PATIENT ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation\n* PATIENT ELIGIBILITY CRITERIA: Poor performance status (Karnofsky performance status \\[KPS\\] \\\u003C 60) that prevent the ability to complete the questionnaires\n* CAREGIVER ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation",{"count":667,"type":22},117,[25],"This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.",[28,671,672],"WHO Grade II Glioma","WHO Grade III Glioma","2026-07-17",{"date":650,"type":33},{"date":676,"type":33},"2019-06-05",{"date":678,"type":22},"2027-02-02",{"name":658,"class":40}]