[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mgmt-methylated-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mgmt-methylated-glioblastoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,79,107],{"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":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100566028","phase-2-g-csf-after-chemo-radiation-in-patients-with-glioblastoma-100566028",false,"NCT06649851","G-CSF After Chemo-radiation in Patients With Glioblastoma","A Phase 2 Randomized Open-Label Pilot Study of Granulocyte Colony Stimulating Factor (G-CSF) to Preserve Brain Structure and Function Following Standard Chemoradiation in Patients With Newly Diagnosed MGMT-Methylated Glioblastoma","Inclusion Criteria:\n\n* Participants must have confirmed newly diagnosed glioblastoma multiforme (GBM), World Health Organization (WHO) grade 4, IDH wildtype, either by histological or molecular criteria.\n* Molecular analysis needs to confirm a positive MGMT promoter methylation status using standard institutional testing methods.\n* Treatment needs to involve a planned 6-week course of standard of care radiation therapy with concurrent and adjuvant 6 monthly chemotherapy with temozolomide. Patients scheduled to receive an abbreviated radiation course (e.g., 3 weeks in elderly patients) are eligible.\n* Age ≥18 years. GBM is considered a biologically distinct disease in children. Children are excluded from this study but will be eligible for future pediatric clinical trials.\n* Karnofsky Performance Status (KPS) \\> 60, see Appendix A\n* No prior cranial irradiation.\n* No existing diagnosis of clinical dementia or high clinical suspicion for presence of any neurodegenerative disease (e.g., Alzheimer's Disease, Fronto-temporal Dementia (FTD), Parkinson's Disease, Motor Neuron Disease, etc.) prior to diagnosis of GBM.\n* Life expectancy of greater than 6 months.\n* Must be able to undergo repeated brain Magnetic resonance imaging (MRI) studies with administration of gadolinium (contrast enhanced brain MRI).\n* Participants must have adequate organ and bone marrow function (as defined below) to be able to receive standard chemoradiation therapy:\n\n  * leukocytes ≥2,500\u002FmcL\n  * absolute neutrophil count≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT)≤3 × institutional ULN creatinine≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2.\n\nFor patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection by history, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants 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 (use of granulocyte colony stimulating factor (G-CSF)) are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to G-CSF (Filgrastim associated allergic reactions).\n* Participants with uncontrolled intercurrent illness that could influence leukocyte counts, such as severe infection requiring intravenous antibiotics, or known HIV (human immunodeficiency virus), since HIV\u002FAIDS is an immunocompromising disease affecting lymphocyte counts (one of the correlative biomarkers in this study)\n* Pregnant women are excluded from this study because of the use of cytotoxic chemotherapy (temozolomide) and radiation, given as part of standard of care in this trial, is of teratogenic potential or has abortifacient effects. Because there is a risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued if the mother is treated with cytotoxic chemotherapy.\n* Participants must be able to undergo repeated neurocognitive testing in English (or Spanish). As cognitive outcome is one of the main secondary endpoints of this study, the lack of normative and comparison data for non-English or non-Spanish-speaking patients would confound this outcome in our small sample size (see Statistical Analysis Plan for more details). Presence of significant aphasia or any other language impairment at time of diagnosis with GBM is considered an exclusion criterion. Any concerns or questions about a subject's ability to participate in neurocognitive testing can be directed to the study investigators for further discussion and clarification.\n* Participants with active thromboembolic event (pulmonary embolism or deep venous thrombosis) or prior thromboembolic event within 6 months prior to diagnosis of GBM may need to be excluded because of possible risks of thromboembolism with the use of G-CSF and will require further discussion with the PI prior to enrollment on a case-by-case basis.\n* Participants with the following medical conditions are excluded and not eligible based on elevated risk of G-CSF associated toxicity: Sickle cell disease or sickle cell trait, congenital neutropenia, hematological malignancy (leukemia or myelodysplastic syndrome).\n* Patients who are dependent on high doses of corticosteroids equivalent to 8mg of daily dexamethasone or more, or who are expected to be unable to taper steroids post-operatively to a dose of 4mg of dexamethasone or less prior to start of chemo-RT.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This research study involves the study of granulocyte colony stimulating factor (G-CSF) in patients with MGMT-methylated glioblastoma multiforme (GBM) that are undergoing standard chemoradiation. The study aims to evaluate G-CSF's effects on brain health and cognitive function.\n\nThe name of the study drugs involved in this study are:\n\n* G-CSF (also called Filgrastim)\n* Temozolomide (TMZ), a standard of care chemotherapy drug",[26,27,28],"MGMT-Methylated Glioblastoma","Glioblastoma (GBM)","Newly Diagnosed Glioblastoma Multiforme",[30,31,32,33],"MGMT-methylated glioblastoma multiforme (GBM)","Newly diagnosed MGMT-methylated glioblastoma multiforme (GBM)","Glioblastoma","Glioblastoma Multiforme (GBM)","RECRUITING","2026-05-03",{"date":37,"type":38},"2026-05-05","ACTUAL",{"date":40,"type":38},"2025-04-02",{"date":42,"type":20},"2030-01-31",{"name":44,"class":45},"Massachusetts General Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"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":56,"type":20},200,[58],"PHASE3","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.",[61,26],"Glioblastoma, IDH-wildtype",[63,64,65,66,67],"precision medicine","temozolomide","lomustine","CCNU","survival","2026-04-07",{"date":70,"type":38},"2026-04-13",{"date":72,"type":38},"2025-02-01",{"date":74,"type":20},"2033-12-15",{"name":76,"class":77},"Vastra Gotaland Region","OTHER_GOV",20,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100554845","phase-1-db107-rrv-db107-fc-and-radiation-therapy-with-or-without-temozolomide-tmz-for-high-grade-glioma-100554845","NCT06504381","DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma","A Phase I\u002FIIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination With DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients With Newly Diagnosed High Grade Glioma","Inclusion Criteria:\n\nEach patient must meet all of the following inclusion criteria to be eligible for study entry:\n\n1. Participant has provided written informed consent.\n2. Participant is between 18 years of age and 75 years of age, inclusive.\n3. Participant must have a Karnofsky Performance Scale (KPS) of \\>= 70.\n4. Participant must have newly diagnosed adult-type diffuse gliomas (World Health Organization Classification 2021) that has not been previously treated with surgery, radiation or chemotherapy (specifically astrocytoma, Isocitrate dehydrogenase (IDH)-mutant or glioblastoma, IDH-wildtype).\n5. Based on the pre-operative evaluation by neurosurgeon, participant is a candidate for \\>= 80% resection of the enhancing region.\n6. The primary tumor must be made available for central testing for IDH1 mutation, O6-methylguanine-DNA methyl-transferase (MGMT) methylation status.\n7. Willing to provide a blood sample to determine Denovo Genomic Marker 7 (DGM7) status.\n8. Laboratory values adequate for patient to undergo surgery, including:\n\n   1. Platelet count \\>= 60,000\u002Fmm\\^3\n   2. Hemoglobin \\>= 10 g\u002FdL\n   3. Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n   4. Absolute lymphocyte count \\>= 500\u002Fmm\\^3\n   5. Total bilirubin \\\u003C=1.5 x upper limit of normal (ULN) (unless patient had Gilbert's syndrome)\n   6. alanine aminotransferase (ALT) \\\u003C= 2.5 x ULN\n   7. Estimated glomerular filtration rate of at least 50 mL\u002Fmin by Cockcroft Gault Formula\n9. Female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30-days prior to the first administration of study drug, for the duration of study participation, and for 90-days following completion of the therapy. Should a female participant become pregnant or suspect a pregnancy while participating in this study, the treating physician must be informed immediately. IF a male participant impregnates or is suspected of impregnating a woman while participating in this study, the treating physician must be informed immediately.\n\n   • A female of child-bearing potential is any women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n   * Has not undergone a hysterectomy or bilateral oophorectomy or\n   * Has not had \\>= 12 months of non-therapy-induced amenorrhea.\n10. Participants must not be breastfeeding.\n11. Participants must have the ability to understand, and the willingness to comply with the scheduled visits, treatment schedule, laboratory testing and other requirements of the study.\n\nExclusion Criteria:\n\nParticipants may not meet any of the following exclusion criteria to be eligible for study entry:\n\n1. Prior treatment for High Grade Glioma (HGG).\n2. History of other malignancy unless the participant has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is not exclusionary regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment.\n3. Histological confirmed oligodendroglioma (IDH-mutant and 1p.19q-codeleted) or mixed glioma.\n4. A contrast-enhancing brain tumor that is any of the following:\n\n   1. Multi-focal (defined as 2 separate areas of presumed tumor whether contrast enhancing or not, measuring at least 1cm in 2 planes that are not contiguous\n   2. Associated with either diffuse subependymal or leptomeningeal dissemination or\n   3. \\> 5cm in any dimension.\n5. Participant has or had an active infection requiring antibiotic, antifungal or antiviral therapy in the 4 weeks preceding study Cycle 1: Day 1.\n6. Participant has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti-inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be interrupted for surgery.\n7. Participant is HIV positive.\n8. Participant has Hepatitis B (positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and positive test for hepatitis B Virus (HBV) DNA) or Hepatitis C (positive tests for hepatitis C Virus (HCV) Antibody and HCV-RNA) or Hepatitis B and C co-infection (positive test for HBsAg or HBcAb and positive test for HCV Antibody).\n9. Participant has a history of allergy or intolerance to flucytosine (DB107-FC).\n10. Participant has a gastrointestinal disease that would, in the opinion of the Investigator, prevent him or her from being able to swallow or absorb flucytosine.\n11. Participant intends to undergo treatment with the Gliadel® wafer at the time of resection surgery or has received Gliadel® wafer \\\u003C 30 days from Cycle 1: Day 1.\n12. Severe pulmonary, cardiac or other systemic disease, which as per Investigator assessment would prevent surgical resection.\n13. Participant who have any other disease or condition, which as per Investigator assessment may affect the participant's compliance or place the participant at higher risk of potential treatment complications.",{"count":87,"type":20},70,[89,23],"PHASE1","This is a multicenter, open-label study of DB107-RRV (formerly Toca 511) and DB107-FC (formerly Toca FC) when administered following surgical resection in newly diagnosed High Grade Glioma (HGG) patients. The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC when added to standard of care provides clinical benefit to newly diagnosed HGG when compared to historical performance previously determined in well controlled clinical trials published in the peer reviewed literature. This study is going to be conducted in newly diagnosed HGG patients receiving with maximum surgical resection treatment followed by radiation and temozolomide treatment using the established Stupp Protocol for O6-methylguanine-DNA methyl-transferase (MGMT) methylated patients or radiation therapy for MGMT unmethylated patients.",[92,93,26],"High Grade Glioma","MGMT-Unmethylated Glioblastoma",[95,96],"Gene therapy","Combination therapy","2026-03-09",{"date":99,"type":38},"2026-03-11",{"date":101,"type":38},"2025-01-08",{"date":103,"type":20},"2042-01-31",{"name":105,"class":45},"University of California, San Francisco",5,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":46},"100592259","phase-2-ruxolitinib-with-radiation-and-temozolomide-compared-to-radiation-and-temozolomide-for-newly-diagnosed-glioblastoma-100592259","NCT06991101","Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma","Randomized Phase 2 Trial of Ruxolitinib in Combination With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma.","Inclusion Criteria:\n\n1. Provision of signed informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.\n4. Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated, unmethylated, or indeterminate MGMT.\n5. Confirmation that patient has sufficient tissue to undergo MGMT and IDH testing, as mandated.\n6. Must have a Karnofsky performance status (KPS) ≥ 70% (i.e., the patient must be able to care for themself with occasional help from others).\n7. Adequate organ (liver and renal) and bone marrow function within 14 days before randomization. For all parameters listed below, the most recent results available must be used:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.\n   2. Platelet count ≥ 100,000\u002Fmm3. Note: Platelet transfusion is not allowed within 1 week prior to registration.\n   3. Total bilirubin (TBL) ≤ 1.5 × institutional upper limit of normal (ULN).\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n   5. Serum albumin ≥ 2.5 g\u002FdL.\n8. Patients able to become pregnant: use of highly effective contraception for at least one (1) month prior to screening and agreement to use such a method. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Such individuals must have a negative pregnancy test.\n9. Patients must have no concurrent malignancy except curatively treated early-stage bladder and prostate cancer that has been completed resected, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ 3 years.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.\n2. Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).\n3. Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study.\n4. Patients who have had repeat craniotomy for tumor therapy after receiving radiation therapy and temozolomide treatment.\n5. Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment.\n6. Patient has previously taken ruxolitinib or is allergic to components of the study drug.\n7. Patients using warfarin.\n8. Uncontrolled immunodeficiency virus infection or active tuberculosis.\n9. Patients with active serious infections requiring systemic therapy.\n10. Known Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Participants with previous positive serology results must have negative polymerase chain reaction results.\n11. Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, New York Heart Association (NYHA) Grade ≥2 heart failure, uncontrolled hypertension, valvular disease, pericarditis, myocardial infarction, or other thrombosis events like including pulmonary embolism or deep vein thrombosis within 6 months of screening.\n12. Any other serious medical\u002Fpsychiatric condition, in the judgement of the investigator, that likely to interfere or limit compliance with study requirements\u002Ftreatment.",{"count":115,"type":20},190,[23],"The purpose of this research is to test the safety and effectiveness of the investigational drug ruxolitinib when it is combined with standard of care treatment (radiation therapy and temozolomide) for the treatment of newly diagnosed glioblastoma. Half the people in the study will be assigned to take the study drug ruxolitinib in addition to the standard of care temozolomide and radiation therapy and the other half will be assigned to the standard of care temozolomide and radiation therapy only. This assignment will be randomized in a 1-to-1 ratio, like the flip of a coin.",[32,119,120,121,122,93,26],"Brain Cancer","Glioblastoma Multiforme","Glioblastoma Multiforme of Brain","Glioblastoma Multiforme, Adult","2025-12-23",{"date":125,"type":38},"2025-12-26",{"date":127,"type":38},"2025-12-03",{"date":129,"type":20},"2030-12",{"name":131,"class":45},"Baptist Health South Florida"]