[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-idh-wildtype\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-idh-wildtype":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,45,69,97,125,154,177,199,229,257,310,331,357,379,402,429,452,472,510,544,571,593,616,632,653],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628937","phase-1-retifanlimab-with-or-without-difluoromethylornithine-for-the-treatment-of-progressive-high-grade-gliomas-100628937",false,"NCT07468136","Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas","Phase I\u002FIIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of high-grade glioma, including any of the following:\n\n  * Glioblastoma, IDH-wild type (WT)\n  * Grade 3 or 4 IDH1\u002F2 mutant astrocytoma or\n  * Grade 3 oligodendroglioma\n  * Any prior grade 2 astrocytoma or oligodendroglioma that is suspected to have recurred at a higher grade\n  * Other high-grade glioma\n* Plan for surgical resection as part of routine clinical care\n* Radiographic disease progression, with or without tissue confirmation\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 and Karnofsky Performance Status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent for the current study\n* Willing to provide consent for the Neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples\n* Ability to complete forms 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* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Uncontrolled intercurrent illness that by the judgement 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 regimens including, but not limited to:\n\n  * ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy\n  * current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids\n  * active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) ≤ 2 years prior to registration\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements (e.g., drug addiction)\n  * concurrent active Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable hepatitis B virus \\[HBV\\] deoxyribonucleic acid \\[DNA\\]) and Hepatitis C virus (defined as anti-hepatitis C virus \\[HCV\\] antibody \\[Ab\\] positive and detectable HCV ribonucleic acid \\[RNA\\]) infection\n\nEXCEPTIONS:\n\n* Patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive) must have completed at least 4 weeks of HBV antiviral therapy, and the HBV viral load must be undetectable at the time of registration\n* Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment ≥ 4 weeks prior to registration.\n\n  * NOTE: Patients without symptoms or prior history do not require testing prior to registration\n\n    * Co-morbid systemic illnesses or other severe concurrent disease that would make the patient inappropriate for entry into the study or interfere with proper assessment of safety and toxicity\n    * History of myocardial infarction ≤ 6 months prior to registration or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n    * Active autoimmune disease that has required systemic treatment (other than replacement therapy) ≤ 1 year prior to registration\n    * History of allogeneic stem cell transplant\n    * Receiving any other investigational agent with therapeutic intent\n    * Participants who are unable to swallow the DFMO solution or who are at risk for impaired absorption of oral medication.\n* NOTE: This restriction includes, but is not limited to, refractory vomiting, gastric resection\u002Fbypass, and duodenal\u002Fjejunal resection\n\n  * Patients with known hypersensitivity or allergy to DFMO or retifanlimab\n  * Contraindication to MRI or administration of gadolinium","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and\u002For effective in treating patients with progressive high grade glioma.",[27,28,29,30,31,32],"Anaplastic Oligodendroglioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Diffuse Astrocytoma","Glioblastoma, IDH-Wildtype","Malignant Glioma","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":34,"type":37},{"date":40,"type":20},"2030-10-25",{"name":42,"class":43},"Mayo Clinic","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100540606","phase-2-identifying-findings-on-brain-scans-that-could-help-make-better-predictions-about-brain-cancer-progression-the-gable-trial-100540606","NCT06319027","Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial","Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)","GABLE","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age.\n* Patient must have a Karnofsky Performance Status ≥ 60%.\n* Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria.\n* Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma.\n* Patient must have completed an MRI prior to the diagnostic surgery for GBM and have images available for upload into Transfer of Images and Data (TRIAD).\n* Patient must have diagnostic surgery for GBM within 7 weeks prior to registration.\n* Patient must have O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status ordered at time of registration.\n* Patient must have a post-operative (op) MRI completed within 3 weeks after diagnostic surgery for GBM and have images available for upload into TRIAD.\n* Patient must have no contraindications to MRI, including injection of gadolinium-based contrast agents, and demonstrated ability to tolerate MRI on pre-surgical imaging.\n* Patient must have no allergies to agents that may potentially be used for non-standard of care imaging (18F-fluciclovine, MR contrast).\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the interventions being used.\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.",{"count":54,"type":20},100,[24],"This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and\u002For magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor.",[31],"2026-06-16",{"date":60,"type":37},"2026-06-18",{"date":62,"type":37},"2024-04-11",{"date":64,"type":20},"2027-05-31",{"name":66,"class":67},"ECOG-ACRIN Cancer Research Group","NETWORK",12,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100610088","phase-1-a-study-of-177lu-psma-617-in-people-with-gliomas-100610088","NCT07223034","A Study of 177Lu-PSMA-617 in People With Gliomas","LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment","Inclusion Criteria:\n\n* Confirmed histologic diagnosis of a WHO grade 2-4 glioma that is IDH1 R132H-wildtype, including the following:\n\n  * Diffuse astrocytoma, IDH-wildtype (grade 2-4)\n  * Glioblastoma, IDH-wildtype\n  * Diffuse midline glioma, H3 K27-altered\n  * Diffuse hemispheric glioma, H3 G34-mutant\n  * Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample\n* Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma\n* Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical\n* Age ≥ 18\n* ECOG ≤ 2\n* Serum creatinine level \\\u003C 1.5 x ULN or EGFR \\> 60 mL\u002Fmin\n* Liver laboratory values: ALT and AST ≤ 2.5 x ULN; Albumin \\> 2 g\u002F dL; Bilirubin \\\u003C 3 X ULN\n* Normal organ and marrow function as defined as the following\n\n  * Total white blood count \\> 3.0 K\u002FmcL\n  * ANC ≥ 1.5 K\u002FmcL\n  * Platelets ≥ 100 K\u002FmcL\n  * Hemoglobin ≥ 9 g\u002FdL\n* Adequate contraception prior to registration (see section 9.0)\n* Ability to understand, and willingness to sign the informed consent.\n\nExclusion Criteria:\n\n* Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)\n* Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma\n* Life expectancy less than 12 weeks\n* Nonhealing wound, ulcer or bone fracture\n* History of severe brain injury\n* Patient not eligible for sequential MRI evaluations\n* Patients with prior RT to \\> 25% of the skeleton or prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Unable to tolerate the PSMA PET\u002FMR or PSMA PET\u002FCT\n* History of viral hepatitis or chronic liver disease with active symptoms\n* History of pituitary or adrenal dysfunction\n* Previously diagnosed active infection (e.g., human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n* Any condition that in the opinion of the investigator, would preclude participation in this study\n* Receipt of any other investigational agents or participation in a concurrent treatment protocol\n* Known allergies, hypersensitivities, or intolerance to 68Ga-PSMA-11\u002F177Lu-PSMA-617 or its inactive compounding components\n* Current or planned pregnancy\n* Refusal to comply with detailed contraception requirements",{"count":77,"type":20},20,[23],"The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma.",[81,82,83,84,85,86],"Glioma","Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4)","Glioblastoma, IDH-wildtype","Diffuse Midline Glioma, H3 K27-Altered","Diffuse Hemispheric Glioma, H3 G34-mutant","Diffuse Pediatric-type High-grade Glioma, H3-wildtype and IDH-wildtype","2026-06-02",{"date":89,"type":37},"2026-06-04",{"date":91,"type":37},"2025-10-27",{"date":93,"type":20},"2027-10",{"name":95,"class":43},"Memorial Sloan Kettering Cancer Center",7,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":44},"100460101","phase-3-repeated-superselective-intraarterial-cerebral-infusion-siaci-of-bevacizumab-with-temozolomide-and-radiation-compared-to-temozolomide-and-radiation-alone-in-newly-diagnosed-gbm-100460101","NCT05271240","Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM","A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Subject must be able to undergo MRI evaluation.\n6. Subject meets the following laboratory criteria:\n\n   i. White blood count ≥ 3,000\u002FμL ii. Absolute neutrophil count ≥ 1,500\u002FμL iii. Platelets ≥ 100,000\u002FμL iv. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).\n\nExclusion Criteria:\n\n1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.\n3. Subject intends to participate in another clinical trial\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject, if female, is pregnant or is breast feeding.",{"count":105,"type":20},432,[107],"PHASE3","Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology.\n\nThe investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg\u002Fkg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I\u002FII clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.",[110,111,112,113,114,83,115],"Glioblastoma","Glioblastoma Multiforme","Glioma, Malignant","GBM","Brain Cancer","Glioblastoma Multiforme, Adult","2026-05-28",{"date":118,"type":37},"2026-06-01",{"date":120,"type":37},"2022-04-27",{"date":122,"type":20},"2028-04-01",{"name":124,"class":43},"Northwell Health",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100639003","phase-2-laser-interstitial-thermal-therapy-litt-with-cemiplimab-or-other-chemotherapy-in-recurrent-glioblastomas-100639003","NCT07620548","Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab or Other Chemotherapy in Recurrent Glioblastomas","A Randomized Phase II Study of the Efficacy of Laser Interstitial Thermal Therapy (LiTT) Combined With Cemiplimab Versus Physician's Choice Chemotherapy in Recurrent Glioblastomas","Inclusion Criteria:\n\n* Histologically confirmed WHO grade 4 GBM (IDH-wt). Note: GBM variants, including histone-mutant and molecular-defined gliomas per WHO 2021 are allowed. Any number of recurrences are permitted.\n* Unequivocal evidence of tumor progression as documented on the screening biopsy.\n* At least 12 weeks post-completion of standard frontline therapy. Standard frontline therapy in this population includes maximal feasible surgical resection (biopsy alone is allowed), radiotherapy, and temozolomide chemotherapy. There is no restriction on the number of adjuvant temozolomide cycles.\n* Candidate for LITT based on the size, location, and shape of the recurrent tumor as determined by the performing neurosurgeon. Surgical resection\u002Fdebulking prior to LITT is allowed per standard of care but is not required; if the patient undergoes resection or debulking, it must have occurred at least 3 weeks prior to the start of any study treatment.\n* At least 18 years of age.\n* Karnofsky performance status ≥ 60%\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n  * INR or PT ≤ 1.5 x IULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)\n  * aPTT ≤ 1.5 x IULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)\n* The effects of cemiplimab on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation (for patients in the Experimental Arm) OR 14 days after completion of study participation (for people of childbearing potential in the Control Arm) or 4 months (for people able to father a child in the Control Arm).\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received prior treatment with any anti-angiogenic agent (including bevacizumab) within 3 months of date of surgery (LITT). (Note: bevacizumab is otherwise permitted when used outside this window for cerebral edema.)\n* Received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD127, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Received prior treatment with a monoclonal antibody within 4 weeks prior to the first day of study treatment.\n* Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first day of study treatment.\n* Has not recovered (i.e., grade 1 or baseline) from adverse events caused by anti-cancer agents administered no more than 4 weeks prior to consent. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion. Note: if a patient underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications prior to the first day of study treatment.\n* Candidate for curative resection or urgent surgical procedure(s) needed.\n* Presence of brainstem lesions or lesions that are \\\u003C 5 mm from the hypophysis or cranial nerves.\n* Multifocal glioma that is bilateral. Patients with unilateral multifocal gliomas may be eligible if their multifocal disease can be treated effectively and safely in a single LITT procedure. Note: Corpus callosal tumors are eligible even if they are bilateral as long as they satisfy the size and shape limits of LITT as determined by the performing neurosurgeon.\n* Presence of leptomeningeal metastases.\n* Recent (within 8 weeks) history of CNS hemorrhage unless the hemorrhage is located within the tumor that will be removed en total during surgical debulking or ablated during LITT.\n* Requires therapeutic doses of anticoagulants unless anticoagulation can be safely discontinued before surgery per standard practice or an IVC filter can be used in place of anticoagulation. Patients are permitted to resume anticoagulation following LITT at the discretion of their treating physician.\n* Received prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of LITT.\n* Received a live vaccine or live-attenuated vaccine within 28 days prior to the first day of study treatment. Received COVID-19 vaccine within 7 days of first dose.\n* Currently receiving any other investigational agents or has participated in a study of an investigational agent or device within 3 weeks of the first day of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.\n* Dexamethasone \\> 4 mg at the time of consent.\n* 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 to the first dose of trial treatment (with the exception of daily dexamethasone ≤ 4 mg).\n* History of immune related pneumonitis or (non-infectious) interstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease in the last 5 years.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection or infection requiring hospitalization or treatment with IV anti-infectives within 14 days of first dose, myocardial infarction within 12 months of first dose, symptomatic congestive heart failure, unstable angina pectoris, acute coronary syndrome within 12 months of first dose, transient ischemic attack or stroke within 12 months of first dose, or cardiac arrhythmia. New York Heart Association Function Classification of class II, II, or IV are exclusionary.\n* Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Pregnant and\u002For breastfeeding. People of childbearing potential must have a negative pregnancy test within 14 days of study entry and again within 72 hours of initiation of cemiplimab (if applicable).\n* Active or latent tuberculosis.\n* History of HIV infection if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.",{"count":133,"type":20},99,[24],"This study will assess the therapeutic efficacy of the combination of Laser Interstitial Thermal Therapy (LiTT) with adjuvant cemiplimab compared to the therapeutic efficacy of the combination of LiTT with physician's choice of adjuvant chemotherapy in patients with recurrent glioblastoma. Patients will be enrolled and randomized on a 2:1 ratio to either the experimental arm (LiTT + cemiplimab) or the control arm (LiTT + physician\u002Fs choice chemotherapy).",[110,83,137],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype",[113,139,140,141,110,142,143],"Recurrent","IDH-wt","IDH-wildtype","Immunotherapy","LiTT","NOT_YET_RECRUITING","2026-05-26",{"date":87,"type":37},{"date":148,"type":20},"2026-08-31",{"date":150,"type":20},"2032-08-31",{"name":152,"class":43},"Washington University School of Medicine",2,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100600005","continuous-glucose-monitoring-for-the-management-of-hyperglycemia-in-patients-with-glioblastoma-100600005","NCT07091864","Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma","Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma","Inclusion Criteria:\n\n* Presumed newly diagnosed GBM based on imaging findings consistent with GBM on brain MRI (e.g., heterogeneously enhancing mass with central necrosis and surrounding edema), as determined by the treating neuro-oncology team\n* Age ≥ 18 years at the time of consent\n* Karnofsky performance status (KPS) ≥ 70 at baseline\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n* Platelet count ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL\u002Fmin\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* Total bilirubin ≤ 1.5 × ULN\n* Willingness and ability to comply with CGM device use and attend dietary counseling sessions as part of the study protocol\n\nExclusion Criteria:\n\n* Recurrent glioblastoma or prior therapy for glioblastoma beyond surgical resection or biopsy\n* History of eating disorders (e.g., anorexia nervosa, bulimia) or substance use disorder within the past 12 months\n* Any other uncontrolled or inadequately managed medical illness (e.g., unstable cardiovascular, hepatic, renal, or psychiatric condition) that, in the opinion of the investigator, would interfere with study participation or interpretation of results\n* Concurrent diagnosis of another active malignancy requiring treatment\n* Pregnancy or breastfeeding at the time of enrollment\n* Documented history of type 1 diabetes mellitus",{"count":162,"type":20},116,[164],"NA","This clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) levels and improve survival. Glioblastoma is the most common malignant primary brain tumor in adults, with an average survival time of approximately 15-18 months despite therapy. Studies have shown that having a higher-than-normal amount of glucose in the blood (hyperglycemia) during radiation therapy is associated with poorer survival outcomes in glioblastoma patients. Hyperglycemia in glioblastoma patients is often driven by steroids that are commonly used during treatment. CGM uses a device that places a sensor under the skin that monitors glucose levels at regular intervals, providing real-time, or near real-time, glucose information. This can help to identify when a patient has changes in their glucose levels so they may receive necessary interventions or medications sooner. CGM may be an effective way for glioblastoma patients to manage their glucose levels, which may improve survival.",[31,167],"WHO Grade 4 Glioma","2026-05-01",{"date":170,"type":37},"2026-05-07",{"date":172,"type":37},"2025-07-29",{"date":174,"type":20},"2027-11-30",{"name":42,"class":43},3,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100627732","phase-3-temporally-modulated-pulsed-radiation-therapy-versus-standard-radiation-therapy-for-the-treatment-of-newly-diagnosed-idh-wildtype-mgmt-unmethylated-glioblastoma-100627732","NCT07452458","Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, IDH Wildtype, MGMT-Unmethylated Glioblastoma","A Randomized Phase III Study Comparing Temporally-Modulated Pulsed Radiation Therapy (TMPRT) Versus Standard Radiation Therapy With Temozolomide for Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered).\n* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis. Note that tissue for central pathology review and central MGMT assessment must be shipped to the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be shipped by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be completed within 10 business days of receipt of tissue. Results will be entered by the central lab directly into Rave. Note: In the event of an additional tumor resection(s), tissue must be shipped within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection.\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to Step 1 registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* No known leptomeningeal disease or metastatic disease outside the brain.\n* Age ≥ 18\n* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.\n* Karnofsky Performance Status ≥ 70\n* Hemoglobin ≥ 10 g\u002Fdl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 10.0 g\u002Fdl is acceptable)\n* Leukocytes ≥ 2,000\u002Fmm\\^3 OR absolute neutrophil count ≥ 1,500\u002Fmm\\^3\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3 x ULN\n* No prior cranial radiation therapy that would result in overlap of radiation therapy fields.\n* No previous therapy for GBM except surgery, laser interstitial thermal therapy (LITT) or Gliadel wafer.\n\n  * Note: 5-aminolevulinic acid (ALA)-mediated fluorescence-guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to\u002Fduring surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent.\n* No history of unstable angina requiring hospitalization in the last 3 months\n* No history of myocardial infarction within the last 3 months\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)\n* No active infection currently requiring IV antibiotic management\n* No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy\n* No movement disorder that could impede ability to lie still with an immobilization mask for approximately 40 minutes\n* No significant sensory deficits (i.e., blindness, mutism) that would prohibit participation of NCF testing\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to temozolomide\n* PRIOR TO STEP 2 REGISTRATION:\n* The following baseline neurocognitive tests must be completed within 28 days prior to Step 2 registration: (Hopkins Verbal Learning Test - Revised \\[HVLT-R\\], Trail Making Test \\[TMT\\], Controlled Oral Word Association \\[COWA\\]). The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. The following scores must be obtained for patient eligibility: HVLT-R Total Recall \\> 5, HVLT-R Delayed Recall \\> 3, HVLT-R Delayed Recognition \\> -10, TMT Part A . 2738, TMT Part B . 3724, COWA . 12. Central review of the Neurocognitive tests will be completed in Rave within 3 business days after the upload is completed. Users with the Rave clinical research associate (CRA) role will be able to view the results in Rave. The CRA must confirm that the results are available and meet eligibility requirements prior to proceeding with Step 2 Registration.\n\n  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.\n  * Note: Patients whose neurocognitive test scores do not meet the criteria above will not be eligible for the study and will be reported as ineligible due to \"Failure to meet Neurocognitive testing criteria\" on Step 2 registration.\n* Pathology proven diagnosis of IDH-wildtype glioblastoma with unmethylated MGMT promoter confirmed by central pathology review. IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e. IDH-wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2.)\n\n  * Central pathology review will generally be completed within 10 business days of receipt of the tissue. Users with the Rave CRA role will be able to view the results in Rave. It must be confirmed that the results are available and meet eligibility requirements prior to proceeding with Step 2 Registration.\n  * Note: Patients with tissue that is insufficient or inadequate for analysis, has failed MGMT testing, or has indeterminate or methylated MGMT promoter are excluded and will be reported as a \"central pathology review failure\" on step 2 registration.",{"count":185,"type":20},398,[107],"This phase III trial compares temporally-modulated pulsed radiation therapy versus standard radiation therapy in treating patients with newly diagnosed, IDH wildtype, MGMT-unmethylated glioblastoma. After completion of surgery, the standard of care for glioblastoma is radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. For older and frail patients, standard treatment also includes the chemotherapy drug temozolomide. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Approximately 70% of glioblastoma patients have MGMT-unmethylated status. MGMT unmethylated tumors are less likely to respond to temozolomide chemotherapy, so there is more reliance on radiation therapy to kill the tumor cells. Recent clinical trials studying new therapies for MGMT-unmethylated glioblastoma have failed to improve outcomes over temozolomide. These recent studies also indicate that 80% of patients experience a decline in memory and thinking function after treatment. TMPRT differs from standard radiation therapy by delivering the same amount of radiation dose in 10-13 \"pulses\" with 3-minute breaks between pulses. TMPRT with temozolomide may work better than standard radiation therapy with temozolomide in increasing survival, as well as improving memory and thinking function in patients with newly diagnosed, IDH wildtype, MGMT-unmethylated glioblastoma.",[31,189],"MGMT-Unmethylated Glioblastoma","2026-04-28",{"date":192,"type":37},"2026-05-04",{"date":194,"type":20},"2026-06-08",{"date":196,"type":20},"2031-07-15",{"name":198,"class":43},"NRG Oncology",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":77},"100548357","phase-3-lomustine-in-addition-to-standard-of-care-in-patients-with-mgmt-methylated-glioblastoma-100548357","NCT06419946","Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma","Phase III Trial of Temozolomide\u002FLomustine (TMZ\u002FLOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +\u002F- Tumor Treating Fields (Optune)","Inclusion Criteria:\n\n* Newly diagnosed glioblastoma\u002Fgliosarcoma, IDH wild type\n* Methylated MGMT promoter\n* World Health Organization performance status 0-2\n* Age 18-70\n\nExclusion Criteria:\n\n* Previous malignancy within 3 y or malignancy treated non-curatively\n* Previous chemotherapy or radiotherapy involving the head\n* Off-protocol tumor-specific treatment\n* Serious comorbidity","70 Years",{"count":208,"type":20},200,[107],"Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile.\n\nHypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ.\n\nTreatment Plans: The study will randomly assign participants to two groups:\n\n* Control Group: Standard treatment with TMZ during and after radiation therapy.\n* Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy.\n\nOutcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes.",[83,212],"MGMT-Methylated Glioblastoma",[214,215,216,217,218],"precision medicine","temozolomide","lomustine","CCNU","survival","2026-04-07",{"date":221,"type":37},"2026-04-13",{"date":223,"type":37},"2025-02-01",{"date":225,"type":20},"2033-12-15",{"name":227,"class":228},"Vastra Gotaland Region","OTHER_GOV",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":44},"100616104","phase-2-gi-102-alone-or-with-pembrolizumab-before-surgery-for-treatment-of-recurrent-or-progressive-idh-wildtype-glioblastoma-and-idh-mutated-grade-4-astrocytoma-100616104","NCT07301268","GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma","MC230719 Window Of Opportunity Study Of GI-102 In Patients With Recurrent High-Grade Glioblastoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma\n  * Candidates for surgical resection\n* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0\n* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml\u002Fmin (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained ≤ 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)\n* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)\n* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willingness to provide blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples collected on this protocol\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) \\\u003C 30 days prior to registration\n\n    * NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Increasing dexamethasone dose prior to registration\n\n    * NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg\u002Fday at time of registration\n  * Received chemotherapy \\\u003C 30 days prior to registration\n  * Received a live vaccine \\\u003C 30 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery \\\u003C 28 days prior to registration\n  * Radiation therapy \\\u003C 14 days prior to registration\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* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring IV antibiotics\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent at the time of registration\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n\n  * NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":237,"type":20},36,[24],"This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.",[31,241,242,243,244,245,246,247,248],"Progressive Astrocytoma, IDH-Mutant, Grade 4","Progressive Glioblastoma","Progressive Gliosarcoma","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","Recurrent Gliosarcoma","Resectable Astrocytoma","Resectable Glioblastoma","2026-04-02",{"date":251,"type":37},"2026-04-08",{"date":253,"type":37},"2026-04-01",{"date":255,"type":20},"2034-04-30",{"name":42,"class":43},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":289,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":309},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732","NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).",{"count":265,"type":20},134,[23,24],"This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[269,83,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288],"Diffuse Astrocytoma, IDH-Mutant","Brain Metastases, Adult","Cervical Cancer","Colorectal Cancer","Esophageal Cancer","Esophageal Squamous Cell Carcinoma","Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer","Non-small Cell Lung Cancer","Renal Cell Carcinoma","Small Cell Lung Cancer","Squamous Cell Carcinoma","Urothelial Carcinoma",[290,291,110,141,292,293,113,294,295,296,297,298],"Astrocytoma","IDH-mutant","Brain Metastases","CNS Tumor","NeOnc","Anova","NEO212","NEO100","TMZ","2026-02-27",{"date":301,"type":37},"2026-03-02",{"date":303,"type":37},"2023-11-01",{"date":305,"type":20},"2027-08-31",{"name":307,"class":308},"Neonc Technologies, Inc.","INDUSTRY",6,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":153},"100506812","phase-2-wp1066-and-radiation-therapy-in-treating-patients-with-newly-diagnosed-glioblastoma-100506812","NCT05879250","WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma","A Multi-Arm, Open Label, Phase II Trial of WP1066 and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Newly diagnosed, histologically confirmed World Health Organization (WHO) glioblastoma multiforme (GBM), IDH wild-type\n\n  * External pathology reports are permitted for confirmation of histological diagnosis\n  * Documentation of isocitrate dehydrogenase (IDH) wild-type status will be by IDH1 R123H immunohistochemistry, except for patients =\\\u003C age 54 for whom IDH sequencing will be required to detect noncanonical IDH mutations\n* Documentation of O6-methylguanine-DNA methyltransferase (MGMT) unmethylated status per testing at any Clinical Laboratory Improvement Amendment (CLIA) certified laboratory\n* Cohort 1 only: Patients with prior gross total resection (GTR)\n* Cohort 2 only: Patients without prior gross total resection (GTR)\n* Cohort 2 only: Measurable disease in the brain (per RANO criteria) on brain magnetic resonance imaging (MRI) scan conducted within =\\\u003C 4 weeks prior to initiating trial therapy\n* Cohort 2 only: Patients who would benefit from non-emergent, palliative surgical resection, in the opinion of the local site's tumor board\n* Able to initiate trial therapy within 8 weeks of the initial brain surgical procedure (biopsy or resection) that lead to the patient's initial diagnosis of GBM\n* Age \\>=18 years\n* Karnofsky performance scale score \\>= 60%\n* White blood cell (WBC) count \\>= 3.0 x 10\\^9\u002FL (within =\\\u003C 30 days prior to registration) (without growth factor support and\u002For receipt of blood products within =\\\u003C 14 days prior to testing)\n* Absolute neutrophil count (ANC) \\>= 1.0 x 10\\^9\u002FL (within =\\\u003C 30 days prior to registration) (without growth factor support and\u002For receipt of blood products within =\\\u003C 14 days prior to testing)\n* Platelet count \\>= 75 x 10\\^9\u002FL (within =\\\u003C 30 days prior to registration) (without growth factor support and\u002For receipt of blood products within =\\\u003C 14 days prior to testing)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) or direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 x ULN (within =\\\u003C 30 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x ULN (within =\\\u003C 30 days prior to registration)\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (within =\\\u003C 30 days prior to registration)\n* Creatinine or creatinine clearance within normal institutional limits. A creatinine level above the institutional normal limit is acceptable, provided creatinine clearance (CrCl) is \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (within =\\\u003C 30 days prior to registration). Creatinine clearance should be calculated using the Cockcroft-Gault formula\n* International normalized ratio (INR) =\\\u003C 1.5 x ULN or for subjects receiving anticoagulant therapy, INR must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator (within =\\\u003C 30 days prior to registration)\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN or for subjects receiving anticoagulant therapy, aPTT must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator (within =\\\u003C 30 days prior to registration)\n* Willing and able to tolerate brain MRI with contrast. Patients with any known severe allergy to contrast agent(s) should not participate in the study. Patients with mild allergies to contrast agents (e.g., rash only) may participate in the study per treating investigator discretion; it is recommended that these patients be pretreated with acetaminophen and diphenhydramine \\[or other institutional standard combination of agent(s) for allergy prep\\] prior to injection of the contrast agent\n* Willing and able to follow the below contraception requirements:\n\nFor Females:\n\n* Female subjects of childbearing potential (defined below) must agree to use adequate contraception (e.g., abstinence or 2 methods of birth control, such as a barrier method in combination with hormonal contraception) starting from the time of informed consent, throughout the duration of treatment with WP1066, and for 2 months after the last dose of WP1066. They also must agree to not donate\u002Ffreeze eggs during the same timeframe. A female of reproductive potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets both of the following two criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy\n  * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n\nFor Males:\n\n* Male subjects must agree to use adequate contraception (e.g., abstinence or 2 methods of birth control, such as a barrier method in combination with partner's use of hormonal contraception) starting from the time of informed consent, throughout the duration of treatment with WP1066, and for 4 months after the last dose of WP1066. They also must agree to not donate sperm during the same timeframe Note: The effects of WP1066 on the developing human fetus are unknown. WP1066 could potentially be teratogenic or have abortifacient effects. 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\n  * Subject (or subject's legally authorized representative if subject has impaired decision-making capacity) must have the ability to understand and the willingness to sign a written informed consent document\n  * Both men and women of all races and ethnic groups may participate in this trial\n\nExclusion Criteria:\n\n* Receipt of investigational agents within =\\\u003C 2 weeks prior to registration\n* Prior receipt of gene therapy, at any time\n* Prior receipt of bevacizumab, at any time\n* Prior receipt of Gliadel, at any time\n* Patients who are on active therapy with Optune and who are unable to safely discontinue Optune prior to initiating trial therapy Note: Patients who can safely discontinue Optune prior to initiating trial therapy may participate\n* Patients who are on active therapeutic anti-cancer therapy and who are unable to discontinue the anti-cancer therapy prior to initiating trial therapy Note: Patients who discontinue anti-cancer therapy prior to initiating trial therapy may participate. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial may participate\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to WP1066 or its excipients\n* Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy Note: These patients are ineligible because of the potential for pharmacokinetic interactions with WP1066. (HIV testing is not required, unless mandated by a local health authority.)\n* Patients who have received drugs that significantly interact with CYP450 enzyme(s) within =\\\u003C 2 weeks prior to planned first study treatment day Note: Patients who are able to safely discontinue the aforementioned agents \\> 2 weeks prior to initiating treatment with WP1066 may participate. The enzymatic metabolism profile of WP1066 is unknown. Drugs that have a minor interaction with CYP450 are allowed, and drugs with a moderate interaction are allowed at the principal investigators (PI's) discretion. Zofran (ondansetron) is allowed\n* Patients who have received any of the following agents within 7 days of planned first study treatment day:\n\n  * Agents that are predominantly CYP2D6, 2C9, or 2C19 substrates\n  * Agents that are strong inhibitors or inducers of CYP2D6, 2C9, or 2C19\n  * Agents that are sensitive substrates of CYP3A4 with narrow therapeutic range Note: Patients who are able to safely discontinue the aforementioned agents \\> 7 days prior to initiating treatment with WP1066 may participate. The enzymatic metabolism profile of WP1066 is unknown. Drugs that are minor CYP2D6, 2C9 or 2C19 substrates; minor inhibitors or inducers of CYP2D6, 2C9, or 2C19; or minor substrates of CYP3A4 are allowed. Moderate drugs will be allowed per PI's discretion. Zofran (ondansetron) is allowed\n* Patients on corticosteroids who require escalation of the corticosteroid dose Note: Patients receiving a stable or decreasing dose for at least one week may participate. Zofran (ondansetron) is allowed\n* History of brain hemorrhage, unless the following exception is met:\n\n  * Exception: Small, asymptomatic brain hemorrhage may be permitted, provided written documentation of PI approval has been obtained Note: The potential for further hemorrhaging with the use of WP1066 is unknown. It will be at the PIs discretion to enroll a patient who has a small, asymptomatic brain hemorrhage, but patients who have had symptomatic hemorrhages will be excluded\n* Uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drug\n* Lesion(s) larger than 50 mm in maximal diameter on MRI, or with midline shift exceeding 5 mm, or with hydrocephalus\n* Diffuse leptomeningeal disease Note: Because one of the objectives is PFS based on radiographic volumetric analysis of the tumor, the presence of diffuse leptomeningeal disease is excluded. This is secondary to the inadequacy of measuring the extent of the tumor burden within this setting and the very poor prognosis of these patients\n* Corrected QT (QTc) B interval \\>= 450 ms These patients are excluded because the cardiac toxicities of WP1066 are unknown. Concomitant use of agents that prolong the QT interval should be avoided whenever feasible, or used with caution. Zofran (ondansetron) is allowed\n* Subjects who are at increased risk for radiation therapy (RT)-associated toxicities, such as those with known active collagen vascular disease (e.g., scleroderma, Sjogren's disease, etc.) or other inherited RT-hypersensitivity syndromes (e.g., Gorlin syndrome, Fanconi anemia, ataxia-telangiectasia, etc.)\n* For female patients of childbearing potential only:\n\nPatients with a positive serum beta-human chorionic gonadotropin (HCG) pregnancy test within =\\\u003C 2 days prior to planned start date for trial therapy or who are immediately planning to become pregnant\n\n* Breastfeeding patients who are unwilling\u002Funable to discontinue breastfeeding while receiving WP1066 Note: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WP1066, breastfeeding should be discontinued if the mother is treated with WP1066. Patients who discontinue breastfeeding prior to initiating treatment with WP1066 may participate\n* Uncontrolled intercurrent illness or condition including, but not limited to any of the following:\n\nOngoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection;\n\n* Symptomatic congestive heart failure\n* Unstable angina pectoris\n* Cardiac arrhythmia\n* Psychiatric illness\u002Fsocial situation that would limit compliance with study requirements\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the subject's safety or study endpoints",{"count":318,"type":20},39,[24],"This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma. Glioblastoma is difficult to treat effectively because the cells within the tumor vary widely and are controlled by factors within and around the tumor, requiring multiple approaches to treat the tumor. The study drug WP1066 targets a specific pathway, known as STAT3, which is responsible for promoting tumor growth and causing the body's immune system to avoid attacking the tumor. Radiation therapy prevents glioblastoma from growing. Giving WP1066 with radiation therapy may prevent glioblastoma from growing and prolong survival.",[31,189],"2025-12-26",{"date":324,"type":37},"2025-12-30",{"date":326,"type":37},"2024-05-22",{"date":328,"type":20},"2028-12-27",{"name":330,"class":43},"Northwestern University",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":21,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":96},"100435049","phase-2-oxidative-phosphorylation-targeting-in-malignant-glioma-using-metformin-plus-radiotherapy-temozolomide-100435049","NCT04945148","Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide","OPTIMUM","Inclusion Criteria:\n\n1. Provision of signed informed consent for selection and treatment phase obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures,\n2. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations including follow-up,\n3. Newly-diagnosed histologically-confirmed supra-tentorial IDHwt glioblastoma (Grade 4 malignant glioma by World Health Organization, including gliosarcoma),\n4. OXPHOS+ subtype by the central laboratory\n5. No prior treatment for GBM other than surgery,\n6. Substantial recovery from surgical resection, no major ongoing safety issues (eg, infection requiring I.V. antibiotics) following surgery,\n7. Without corticosteroids or with stable dose of corticosteroids (ie ≤ dexamethasone 6 mg, methylprednisolone 30 mg or prednisone 38 mg),\n8. ECOG (Eastern Cooperative Oncology Group) performance status 0-2,\n9. Able to receive concomitant radio-chemotherapy according to the Stupp protocol (60Gy) based on investigator judgment,\n10. Adequate bone marrow and normal hepatic function,\n11. Creatinine clearance ≥ 30 mL\u002Fmin (between 30 and 50 ml\u002Fmin, patients will be prescribed no more than 1500mg of metformin),\n12. Able to start RT within 7 weeks after histological diagnosis,\n13. Patients must have life expectancy ≥ 16 weeks,\n14. Patients affiliated to an appropriate health insurance system,\n15. Age ≥ 18 years old,\n16. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to the start of study drug,\n17. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception from the signing of the informed consent and continue throughout period of taking study treatment and for 30 days after last dose of study drug (duration of ovulatory cycle) plus the time required for the investigational drug to undergo five half-lives (both TMZ and metformin). The terminal half-life of temozolomide is 1.8 hours. The terminal half-life for metformin is 6.5 hours.\n18. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception throughout the period of taking study treatment and for 6 months plus the time required for the investigational drug to undergo five half-lives (both TMZ and metformin). The terminal half-life of temozolomide is 1.8 hours. The terminal half-life for metformin is 6.5 hours.\n19. White blood cells (WBC) ≥ 2000\u002FμL\n20. Neutrophils ≥ 1500\u002FμL,\n21. Platelets ≥ 100 x103\u002FμL,\n22. Hemoglobin ≥ 9.0 g\u002FdL,\n23. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (using the Cockcroft-Gault formula) Female CrCl = (140-age in years) x weight in kg x 0.85 72 x serum creatinine in mg\u002FdL Male CrCl = (140-age in years) x weight in kg x 1.00 72 x serum creatinine in mg\u002FdL\n24. Aspartate AminoTransferase (AST) ≤ 3.0 x ULN,\n25. Alanine Aminotransferase (ALT) ≤ 3.0 x ULN,\n26. Total Bilirubin ≤ 1.5 x ULN (except patients with Gilbert Syndrome who may have a total bilirubin \\\u003C 3.0 x ULN).\n\nExclusion Criteria:\n\n1. Prior treatment for GBM (other than surgical resection) including Gliadel wafer,\n2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years,\n3. Any known metastatic extracranial or leptomeningeal disease,\n4. IDH mutant,\n5. Secondary GBM (ie, progression from prior low-grade or anaplastic glioma),\n6. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy, or interfere with the interpretation of study results,\n7. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication (inflammatory bowel disease, major bowel resection),\n8. Pregnant or breast-feeding women,\n9. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving anti-viral therapy,\n10. Patients with known active hepatitis (i.e., Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)),\n11. Patients with a known hypersensitivity to metformin and temozolomide or any of the excipients of the products,\n12. Patients with severe renal insufficiency ie, CrCl \\\u003C 30 mL\u002Fmin (who should not receive contrast materials),\n13. History or evidence upon physical\u002Fneurological examination of other central nervous system condition (eg, seizures, abscess) unrelated to cancer, unless adequately controlled by medication or considered not potentially interfering with protocol treatment,\n14. Patients unable (eg, due to pacemaker or Implantable Cardioverter Defibrillator (ICD) device) or unwilling to have a contrast-enhanced MRI of the head,\n15. Any acute medical condition that may impair renal function such as dehydration, severe infection, shock,\n16. Any disease which may cause tissue hypoxia such as decompensated heart failure, respiratory failure, recent myocardial infarction\n17. Past Diabetic precoma\n18. Past Acute metabolic acidosis,\n19. Alcohol intoxication and Alcoholism,\n20. Persons protected by a legal regime (guardianship, trusteeship),\n21. Prisoners or patients who are involuntarily incarcerated,\n22. Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.",{"count":339,"type":20},640,[24],"Tailored approaches targeting crucial oncogenes and pathways have shown successful results in a number of cancer types and offer exciting perspective in neuro-oncology. IDH (Isocitrate dehydrogenase) wild-type (IDHwt) glioblastoma (GBM) (10%) present a unique and homogenous energetic metabolism which is specifically dependent on the oxidative phosphorylation (OXPHOS) rather than on the aerobic glycolysis. OXPHOS+ IDHwt GBMs overexpress mitochondrial markers and can be specifically inhibited by mitochondrial inhibitors in vitro and in vivo.\n\nMetformin is an oral inhibitor of mitochondrial complex I and is a widely used drug in diabetic and non-diabetic patients, safe and well tolerated in association with radiotherapy and chemotherapy.\n\nBasing on drastic effect, the investigators have observed in vivo (reduction of \\>50% of tumor growth) and hypothesize that metformin could be specifically efficient to treat up-front patients affected by OXPHOS+ GBM, in association with the standard first-line treatment with radiotherapy and temozolomide (RT-TMZ).\n\nThe investigators set up a dedicated molecular analysis including RNA assay and expression of OXPHOS markers for formalin-fixed paraffin-embedded tumors (FFPE), which allows to detect OXPHOS+ GBM at diagnosis.\n\nHere a phase II, open label, non-randomized multicenter trial including five French neurooncology centers (H. Foch-Suresnes, Pitié-Salpêtrière-Paris, Saint Louis-Paris, Lyon, Marseille) and one in Italy (Istituto Besta, Milan) is proposed.\n\nNewly diagnosed IDH wild-type GBM patients with the OXPHOS+ signature will be eligible for inclusion in this trial. The investigators expect to screen 640 patients and to include 64 patients over a period of 24 months with 24 months of follow-up.",[83],[110,344,345,346,347],"FGFR3-TACC3","Metformin","Radio-chemotherapy","OXPHOS+","2025-11-18",{"date":350,"type":37},"2025-11-21",{"date":352,"type":37},"2024-05-10",{"date":354,"type":20},"2028-05",{"name":356,"class":43},"Hopital Foch",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":21,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":44},"100510673","phase-2-phase-2-open-label-single-arm-study-on-the-use-of-metformin-as-adjunctive-therapy-in-high-grade-glioma-100510673","NCT05929495","Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma","Inclusion Criteria:\n\n* Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;\n* hypomethylation or hypermethylation of MGMT assessed post-surgery;\n* adult patients (≥18 years), both sexes;\n* Patients undergoing Stupp protocol including patients aged \\> 70 years performing the hypofractionated protocol and three weeks of chemotherapy;\n* Karnofsky Performance Status (KPS)\\> 60 assessed post-surgery;\n* life expectancy at least 6 months defined by size and location of lesion tumor;\n* freely given written informed consent prior to any activity related to the study. Patients must be able to communicate with the investigator and comply with the study procedures;\n* Women of childbearing age must test negative for pregnancy at enrollment and, if they have sexual intercourse, they must agree to use specific contraceptive methods. Female subjects of childbearing age, i.e., fertile, after menarche and until post-menopause unless they are permanently infertile, who are sexually active, must apply a highly effective method of birth control with a low failure rate (i.e., less than 1 percent per year), such as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral intravaginal, or transdermal), progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone delivery system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks after the last dose of the study treatment. Hormonal methods other than levonorgestrel-containing devices or medroxyprogesterone injections should be supplemented with the use of a male condom. Women of nonfertile age may be included if surgically sterile or postmenopausal for at least 2 years. The investigator is responsible for determining whether the patient has adopted an appropriate method of contraception for participation in the study.\n* Male subjects with female partners of childbearing age must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n* Multicenter GBMs;\n* Patients diagnosed with diabetes or diabetes-related conditions;\n* other active malignancies;\n* hypersensitivity, intolerance to metformin or excipients;\n* Impaired renal function with creatinine clearance \\\u003C 60 mL\u002Fmin assessed at recruitment, liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use;\n* taking metformin, insulin or other biguanides, regardless of the reason;\n* pregnancy or lactation;\n* patient has serious pre-existing medical conditions that, in the opinion of the investigator, would preclude participation in this study.",{"count":5,"type":20},[24],"About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies.\n\nThis is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months.\n\nThe clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.",[83,345,367],"Malignancies",[345,369,113],"Gliomas","2025-07-24",{"date":372,"type":37},"2025-07-25",{"date":374,"type":37},"2024-02-12",{"date":376,"type":20},"2026-01-01",{"name":378,"class":43},"University of Milano Bicocca",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":21,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100506821","phase-1-evaluation-of-eflornithine-plus-temozolomide-in-patients-with-newly-diagnosed-glioblastoma-or-astrocytoma-100506821","NCT05879367","Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A\u002FB intact) per WHO 2021 tumor classification.\n* Completed external beam radiation therapy per standard of care.\n* Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.\n* Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.\n* Willing to abstain from intercourse or use acceptable contraceptive methods.\n* If taking corticosteroids, must be on a stable or decreasing dose.\n\nExclusion Criteria:\n\n* Recent history of recurrent or metastatic cancer that could confound response assessments\n* Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).\n* Prior Optune treatment.\n* Active infection or serious intercurrent medical illness.\n* Poorly controlled seizures.\n* Significant cardiac disease within 6 months of enrollment.\n* Poorly controlled diabetes.\n* Use of another investigational agent within 30 days of enrollment.",{"count":387,"type":20},66,[23],"The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.",[83,110,111,137,113,290,391],"Astrocytoma, IDH-Mutant","2025-06-19",{"date":394,"type":37},"2025-06-25",{"date":396,"type":37},"2023-07-24",{"date":398,"type":20},"2026-06-30",{"name":400,"class":308},"Orbus Therapeutics, Inc.",8,{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":21,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":44},"100511576","stem-cell-analysis-omics-including-immunomics-and-artificial-intelligence-in-glioblastoma-100511576","NCT05941234","Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma","Improving Personalised Glioblastoma Care by Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence Approaches","IPerGlioGEM","Inclusion Criteria:\n\nTo be enrolled in the study patients must:\n\n1. Have a radiological diagnosis of supratentorial glioblastoma, or\n2. Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria;\n3. Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery Fondazione Policlinico Gemelli IRCCS;\n4. Be of an age of 18 years or above;\n5. Provide written informed consent for participation to the study.\n\nExclusion criteria\n\nTo be enrolled in the study patients must not:\n\n1. Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;\n2. Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2021 World Health Organization classification.",{"count":411,"type":20},120,[164],"The study aims at:\n\n1. Perform a multilayer analysis relying on tight integration of in-depth multi-omics approaches with clinical data to discover immune markers, with attention to age and sex differences, predicting prognosis and defining key life\u002Fenvironmental elements, to guide AI-driven personalised treatments and ensure improved care and QoL of glioblastoma patients.\n2. To deepen glioblastoma knowledge through the study of glioblastoma stem cell cultures and to assess the sensitivity of glioblastoma stem cell cultures to a number of chemotherapeutics in different experimental conditions.\n3. To create a comprehensive, stakeholder-generated guidelines for the ethical use of patient data for artificial intelligence-assisted prediction systems in glioblastoma, including an online, easily accessible patient information brochure to increase patient empowerment in the field.",[83],[416,417,418,419],"glioblastoma","tumor microenvironment","cancer stem cell","artificial intelligence","2025-03-11",{"date":422,"type":37},"2025-03-13",{"date":424,"type":37},"2024-02-29",{"date":426,"type":20},"2026-12-30",{"name":428,"class":43},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":21,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":44},"100548216","phase-1-neoadjuvant-radio-chemotherapy-safety-pilot-study-in-patients-with-glioblastoma-100548216","NCT06418113","Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma","GLINERA","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Unifocal disease.\n* Unilobar tumor.\n* Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.\n\nExclusion Criteria:\n\n* Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease.\n* Midline shift greater than 1 cm.\n* Intracranial hypertension symptoms requiring corticosteroid treatment.\n* Synchronous neoplasia.\n* Any contraindication for surgery, radiotherapy, or TMZ treatment.\n* Cognitive impairment.\n* Rejection of informed consent.\n* Inability to follow up for 2 years.\n* Women of childbearing potential according to the Clinical Trial Facilitation Group (CTFG) criteria. (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01-About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1.pdf)\n* Hypersensitivity to the active ingredient or any excipients of the investigational drug.","75 Years",{"count":68,"type":20},[23],"The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are:\n\n* What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula?\n* What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life?\n\nParticipants will undergo the following tasks and treatments:\n\n* Stereotactic biopsy and diagnosis confirmation.\n* Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide.\n* Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring.\n* Maintenance temozolomide administration for 6 months.\n\nResearchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.",[110,111,83,441,442],"Radiotherapy; Complications","Cancer Brain","2024-05-13",{"date":445,"type":37},"2024-05-16",{"date":447,"type":37},"2024-03-21",{"date":449,"type":20},"2027-03-21",{"name":451,"class":43},"Hospital San Carlos, Madrid",{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":458,"enrollmentInfo":459,"targetDuration":4,"studyType":21,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":44},"100541253","phase-2-evaluate-the-efficacy-and-safety-of-atorvastatin-combined-with-temozolomide-in-the-treatment-of-glioblastoma-100541253","NCT06327451","Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma","Inclusion Criteria:\n\n1. age ≥18 years old and \\\u003C 60 years old, both sexes;\n2. sufficient evidence of glioma by MRI scan;\n3. According to the 2021 WHO latest classification, the molecular pathology of postoperative glioma samples was diagnosed as WHO 4 glioblastoma;\n4. The immunohistochemical results of postoperative glioma samples showed that EGFR score was 3 (standard: 0 was negative, 1-3 was positive);\n5. normal blood routine and liver function;\n6. fully understand the nature of the trial and sign the informed consent;\n7. be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;\n8. no serious diseases or accidents requiring surgery;\n9. normal immune function.\n\nExclusion Criteria:\n\n1. allergy to atorvastatin or its components;\n2. concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;\n3. other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral hernia and other serious complications;\n4. History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic diseases;\n5. abnormal liver function or liver disease, including uncontrolled hepatitis;\n6. other diseases that might interfere with the study, as determined by 2 attending neurosurgeons;\n7. patients enrolled in a clinical trial within the past 4 weeks;\n8. pregnant or lactating patients;\n9. patients with poor compliance who could not complete the treatment;\n10. other conditions that made the patient ineligible for enrollment as determined by the study investigator;\n11. patients with a history of HIV and\u002For HBV\u002FHCV or presence of HIV\u002FHCV;\n12. patients with a history of tuberculosis or known existence of tuberculosis;\n13. patients with severe infection or signs\u002Fsymptoms of infection within 2 weeks before the first dose of study drug;\n14. patients who received live attenuated vaccine within 4 weeks before the first dose of study drug;\n15. patients with previous solid organ transplantation or hematopoietic stem cell transplantation.\n\nThose who meet any of the above criteria will not be selected.","60 Years",{"count":460,"type":20},50,[24],"Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression.\n\nThe investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight.\n\nThe results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety.",[83],{"date":465,"type":37},"2024-03-25",{"date":467,"type":20},"2024-04-01",{"date":469,"type":20},"2027-02-28",{"name":471,"class":43},"Tianjin Medical University General Hospital",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":480,"enrollmentInfo":481,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":484,"conditions":485,"keywords":490,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":401},"100537907","the-recsur-study-resection-versus-best-oncological-treatment-for-recurrent-glioblastoma-encram-2302-100537907","NCT06283927","The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)","The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)","RECSUR","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. The tumor is suitable for resection (according to neurosurgeon)\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Medical reasons precluding MRI (e.g., pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Clinical data unavailable for the newly diagnosed setting","90 Years",{"count":482,"type":20},464,"OBSERVATIONAL","Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.\n\nThis study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study has been approved by the Medical Ethics Committee (METC Zuid-West Holland\u002FErasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.",[110,111,83,486,115,487,488,489],"Glioblastoma Multiforme of Brain","Recurrent Glioblastoma","Astrocytoma, Malignant","Astrocytoma of Brain",[110,491,492,493,494,495,496,497,498,499,500],"Radiotherapy","Chemotherapy","Re-resection","Resection","Overall survival","Progression-free survival","Neurological morbidity","Safety","Serious Adverse Events","Quality of life","2024-02-21",{"date":503,"type":37},"2024-02-28",{"date":505,"type":37},"2023-01-01",{"date":507,"type":20},"2028-01-01",{"name":509,"class":43},"Jasper Gerritsen",{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":480,"enrollmentInfo":518,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":520,"conditions":521,"keywords":526,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":541,"leadSponsor":542,"locationsCount":401},"100537080","the-recmap-study-resection-with-or-without-intraoperative-mapping-for-recurrent-glioblastoma-100537080","NCT06273176","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)","RECMAP","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)19\n4. The tumor is suitable for resection (according to neurosurgeon)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Multifocal contrast-enhancing lesions\n3. Medical reasons precluding MRI (e.g., pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Clinical data unavailable for the newly diagnosed setting",{"count":519,"type":20},225,"Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.\n\nThis study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[83,110,486,488,522,523,524,525,487],"Brain Neoplasms","Brain Neoplasms, Adult, Malignant","Brain Neoplasms, Adult","Recurrent Adult Brain Tumor",[110,139,493,494,527,528,529,530,531,532,495,496,497,500,533,534,535,536],"Intraoperative mapping","Awake mapping","Awake craniotomy","Asleep mapping","Motor mapping","Language mapping","Functional area","Eloquent","Extent of resection","Residual tumor volume","2024-02-20",{"date":539,"type":37},"2024-02-22",{"date":505,"type":37},{"date":507,"type":20},{"name":543,"class":43},"Erasmus Medical Center",{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":480,"enrollmentInfo":552,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":554,"conditions":555,"keywords":562,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":401},"100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206","NCT06118723","The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","SUPRAMAX","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Multifocal contrast enhancing lesions\n3. Medical reasons precluding MRI (e.g. pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin",{"count":553,"type":20},784,"A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[110,556,83,557,115,558,559,488,522,560,524,561],"High-grade Glioma","Glioblastoma, IDH-mutant","Astrocytoma, Grade IV","Astrocytoma, Grade III","Brain Neoplasm, Primary","Brain Neoplasm, Malignant",[110,563,564,565,497,500,495,496],"Supramaximal resection","FLAIRectomy","Non-contrast enhancement",{"date":539,"type":37},{"date":568,"type":37},"2022-01-01",{"date":507,"type":20},{"name":509,"class":43},{"id":572,"slug":573,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":591,"locationsCount":44},"100528424","analyzing-and-solving-exceptional-long-term-survivors-in-solid-tumors-with-poor-prognosis-100528424","NCT06160596","Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis","Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study","ROSALIND","Inclusion Criteria:\n\nFOR SURVIVORS\n\n* To be eligible the exceptional survivor patients must fulfill the following inclusion criteria:\n\n  1. Adult patient (≥18 years old at diagnosis).\n  2. Three distinct cohorts, one of patients harbouring metastatic pancreatic ductal adenocarcinoma, glioblastoma IDHwt, extensive small cell lung cancer.\n  3. Long-term survival is defined as an exceptionally long survival ≥ 5 years from stage IV diagnosis for PDAC, extensive SCLC, and ≥ 3 years for GBM-IDHwt.\n  4. Availability of at least one block sample and associated clinical annotations with following characteristics:\n\n     * One block sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses, according to requirements specified in Lab manual\n     * Any treatment prior to sample acquisition must be reported - all treatments accepted (standard \u002F targeted);\n     * Samples should be at least 5 years old for PDAC and SCLC and 3 years old for GBM\n\nFor CONTROL GROUPS :\n\n* To be eligible the control patients must fulfill the following inclusion criteria:\n\n  1. ≥18 years old at diagnosis.\n  2. Three distinct cohorts, one of patients suffering from metastatic pancreatic ductal adenocarcinoma, one for glioblastoma, one for extensive small cell lung cancer.\n  3. Paired to long-term survivors as mentioned in the methodology section\n  4. Death or median overall survival with a variation of 10% before of beyond as reported in pivotal clinical trials in the specific type disease\n  5. Availability of at least one tumor sample and associated clinical annotations with following characteristics:\n\n     * Sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses\n     * Any treatment prior to sample acquisition must be reported (treatment-naive samples should be preferred) - all treatments accepted (standard \u002F targeted).\n\n     Exclusion Criteria for both groups :\n* Patient must not be enrolled if he\u002Fshe fulfils one of the following non-inclusion criteria:\n\n  1. \\\u003C18 years old at diagnosis.\n  2. Hematological malignancy or solid tumors, which are not in the scope of tumor types, described in the inclusion criteria.\n  3. Tumor sample not available or not reaching the required quality for multi-omic analyses.",{"count":580,"type":20},1020,"This is a retrospective, exploratory, multi-center, translational, 3 cohorts case control matched study conducted in patients harboring a solid tumor with poor prognosis who presented a long-term (case) and standard (standard) survival.\n\nPatients with:\n\n* Cohort A: metastatic pancreatic ductal adenocarcinoma\n* Cohort B: glioblastoma IDHwt\n* Cohort C: extensive small cell lung cancer\n\nThis research aims to integrate data generated from clinical records, imaging, multi-omics and bioinformatics approaches to discriminate case and control and then to identify new therapeutic targets. Analyses will be performed depending on the tumor samples available with at least 3 omics levels and according to scientific advances; genomic, epigenomic, proteomics, metabolomics, transcriptomic, microbiomic.",[583,584,83],"Pancreas Adenocarcinoma","Small-cell Lung Cancer","2023-11-29",{"date":587,"type":37},"2023-12-07",{"date":303,"type":37},{"date":590,"type":20},"2028-05-01",{"name":592,"class":43},"Cure 51",{"id":594,"slug":595,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":480,"enrollmentInfo":600,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":613,"leadSponsor":615,"locationsCount":401},"100527359","the-palsur-study-palliative-care-versus-surgery-in-high-grade-glioma-patients-encram-2203-100527359","NCT06146738","The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)","PALSUR","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Inability to give written informed consent\n3. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n4. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin",{"count":601,"type":20},1015,"There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.",[110,111,83,115],[605,606,607,494,500,608,110],"Palliative care","Best supportive care","Biopsy","Survival","2023-11-18",{"date":611,"type":37},"2023-11-27",{"date":505,"type":37},{"date":614,"type":20},"2029-01-01",{"name":509,"class":43},{"id":617,"slug":618,"hasResults":11,"nctId":619,"briefTitle":620,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":480,"enrollmentInfo":623,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":625,"conditions":626,"keywords":627,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":630,"leadSponsor":631,"locationsCount":401},"100527358","the-resbiop-study-resection-versus-biopsy-in-high-grade-glioma-patients-encram-2202-100527358","NCT06146725","The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)","RESBIOP","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Medical reasons precluding MRI (e.g. pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin",{"count":624,"type":20},564,"There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.",[110,83,111,115,486],[494,607,608,500],{"date":611,"type":37},{"date":505,"type":37},{"date":614,"type":20},{"name":509,"class":43},{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":206,"enrollmentInfo":639,"targetDuration":4,"studyType":21,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":44},"100504013","phase-2-elemene-plus-stupp-protocol-versus-stupp-protocol-alone-for-newly-diagnosed-glioblastoma-100504013","NCT05842746","Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma","Efficacy and Safety of Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma: A Multi-center Phase II Randomized Controlled Trial","Inclusion Criteria:\n\n* newly-diagnosed supratentorial glioblastoma, IDH-wildtype, WHO grade 4\n* male or female adult patients \\\u003C 70 years old\n* Karnofsky performance status (KPS) score higher or equal to 60\n* a minimum life expectancy of 12 weeks\n* adequate bone marrow function (white blood cell ≥ 2.0 × 10\\^9\u002FL, neutrophils ≥ 1.5 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, and platelets ≥ 100 × 10\\^9\u002FL)\n* adequate hepatic function (direct bilirubin and indirect bilirubin ≤ 1.5 mg\u002FdL, and alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 4 times the upper limit of normal)\n* adequate renal function (creatinine \\\u003C 80 umol\u002FL)\n* adequate coagulation function (international normalized ratio \\[INR\\] ≤ 1.3)\n* voluntary to participate in this trial, complete all pre-specified treatment regimens, and complete required follow-up\n\nExclusion Criteria:\n\n* unwilling to participate or accept the pre-specified treatment regimen and required follow-up schedule\n* prior treatment (surgery, radiotherapy, chemotherapy) for glioblastoma\n* pregnant or lactating patients\n* allergic to Elemene and its components\n* severe liver and kidney dysfunction, coagulation disorders, or decreased hematopoietic ability\n* serious infection\n* serious hyperlipidaemia\n* medical illness or psychosocial circumstance that may compromise participant safety",{"count":640,"type":20},74,[24],"The goal of this phase II randomized clinical trial is to compare the safety and efficacy of Elemene plus Stupp Protocol (the new protocol) and Stupp Protocol alone (the standard protocol) in patients with newly-diagnosed glioblastomas (ndGBMs). The main questions to answer are:\n\n* Whether the new treatment protocol (Elemene plus Stupp Protocol) is clinically safe for ndGBM patients.\n* Whether the new treatment protocol (Elemene plus Stupp Protocol) brings better survival benefits for ndGBM patients compared to the standard-of-care Stupp Protocol.\n\nStudy participants will be enrolled in 5 hospitals in China and randomly assigned to receive either the new protocol or the standard protocol. The overall survival (OS) rate in the 12th month, the progression-free survival (PFS) rate in the 6th month, OS, PFS, and adverse events assessed by the CTCAE (Common Terminology Criteria for Adverse Events) will be evaluated for all patients.",[83],"2023-04-22",{"date":646,"type":37},"2023-05-06",{"date":648,"type":20},"2023-05",{"date":650,"type":20},"2027-05",{"name":652,"class":43},"Peking Union Medical College Hospital",{"id":654,"slug":655,"hasResults":11,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":483,"phases":4,"briefSummary":662,"conditions":663,"keywords":664,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":44},"100464333","therapeutic-outcomes-related-to-gut-microbiome-in-glioblastoma-gbm-patients-receiving-chemo-radiation-therabiome-gbm-100464333","NCT05326334","THERApeutic Outcomes Related to Gut microBIOME in Glioblastoma (GBM) Patients Receiving Chemo-radiation (THERABIOME-GBM)","THERApeutic Outcomes Related to Gut microBIOME in Glioblastoma (GBM) Patients Receiving Chemo-radiation: A Prospective Observational Study","THERABIOME-GBM","Inclusion Criteria:\n\n* Patients with newly diagnosed WHO grade 4 glioblastoma, IDH-1 R132H wild type\n* Maximum safe resection (≥70% of initial tumor volume resected)\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 or ECOG 2 if on ≤ 8 mg\u002Fday of dexamethasone (or bioequivalent)\n* Plan to receive 60 Gy \u002F 30 fractions of radiation with temozolomide within 12 weeks of surgery\n* Patient or substitute decision maker able to provide written informed consent\n\nExclusion Criteria:\n\n* Metastatic cancer or secondary cancer that could affect interpretation of primary and secondary study outcomes\n* Receiving additional systemic therapy \u002F clinical intervention for glioblastoma that would prevent a uniform treatment cohort with temozolomide and radiation x 6 weeks followed by adjuvant temozolomide 150-200 mg\u002Fm2 on days 1-5 every 28 days for up to 6 cycles.\\*\n* Inability to collect study stool samples\n* Any diagnosis or medical condition, physical and \u002F or psychological, that the investigator feels precludes the patient from participation in the study.\n\n  * If there is a new standard of care treatment for newly diagnosed GBM before the first patient is enrolled (e.g., Optune Tumor Treating Fields), then we will allow all patients on this study to adopt the new standard of care therapy. To allow for maximum patient accrual, if patient chooses to enroll on an open label randomized therapeutic study whereby the control arm involves only the standard of care treatment, then patients enrolled in the control arm could be eligible for this study at the discretion of the investigator.",{"count":77,"type":20},"This is a pilot or feasibility study to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. Eligible participants (adults with newly diagnosed glioblastoma multiforme \\[GBM\\] and had a good tumour resection \\[\\>= 70% of initial tumour volume\\] and plan to receive 6 weeks of chemoradiation followed by up to 6 months of chemotherapy) are asked to donate their own stool samples at 4 different time points during their treatment course. Participants will also complete a 7-day diet diary and two questionnaires about their health-related quality of life.\n\nGlioblastoma multiforme (GBM) is the most common and aggressive form of primary brain cancer in adults. The current best evidence-proven treatment for GBM includes maximum safe tumour resection, brain radiation over a 6-week period given with chemotherapy pills called temozolomide (Brand name: Temodal or Temodar), followed by approximately 6 months \u002F cycles of temozolomide. Despite these treatments, the average life expectancy is generally less than 2 years.\n\nResearchers are recognizing that the immune system has an important role in directing the effectiveness of chemotherapy, radiation, and newer therapies such as immunotherapies. Some immunotherapies have been quite successful in improving cancer control and survival in other cancers like melanoma (an aggressive skin cancer), but when these drugs were given to patients with GBM, there appeared to only be a small effect. Therefore, finding ways to make existing and new treatments work better should be a priority. Recent scientific studies have shown that the bacteria that make up our stool, often referred to as the gut microbiome, play a major role in regulating the immune system. For example, researchers were able to make patients with melanoma who previously did not respond to immunotherapy become responsive to the treatment after receiving a stool transplant from responders to immunotherapy. This provides proof of concept that we could modify the body's immune environment to favour cancer killing by changing a person's gut bacteria environment.\n\nThe role of the gut bacteria in patients with brain cancer is poorly understood as very few studies have been published about it in this population. We believe that understanding the composition of the gut microbiome and how it relates to the effectiveness and side effects of treatments in GBM patients will be an important first step to understanding how we can modify the gut microbiome to improve outcomes for patients living with GBM.",[83],[665,666],"Gut microbiome","Glioblastoma multiforme","2023-04-12",{"date":669,"type":37},"2023-04-18",{"date":671,"type":37},"2023-03-02",{"date":673,"type":20},"2029-09",{"name":675,"class":43},"Ottawa Hospital Research Institute"]