[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioma-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioma-malignant":42},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,64,77,111,136,161,185,205,235,263,298,320,348,369,391,421,443,476,502,524,551,575,596,630,646],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":44,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100053479","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100053479",false,"NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo craniotomy for brain biopsy and\u002For resection\n\n  --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able to achieve a gross total resection of tumor will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","ALL","18 Years","99 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioma","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","High Grade Glioma","Glioma, Malignant","Brain Cancer",[29,36,45,46,47,48,49,50,43],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","RECRUITING","2026-07-10",{"date":54,"type":55},"2026-07-13","ACTUAL",{"date":57,"type":22},"2026-07-16",{"date":59,"type":22},"2032-12-31",{"name":61,"class":62},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":65,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":27,"conditions":68,"keywords":69,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":63},"100624942",{"count":21,"type":22},[25,26],[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],[29,36,45,46,47,48,49,50,43],"2026-07-01",{"date":72,"type":55},"2026-07-02",{"date":74,"type":22},"2026-07-07",{"date":59,"type":22},{"name":61,"class":62},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":63},"100404547","phase-1-phase-1-trial-of-d2c7-it-in-combination-with-2141-v11-for-recurrent-malignant-glioma-100404547","NCT04547777","Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma","A Phase 1 Trial of D2C7-IT in Combination With an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) Administered Intratumorally Via Convection-Enhanced Delivery Followed by Perilymphatic Injections of 2141-V11 and Assessment of the Tumor Monorail for Adult Patients With Recurrent Malignant Glioma","Inclusion Criteria:\n\n1. Study population:\n\n   1. Subgroup #2: Histopathologically confirmed recurrent supratentorial WHO grade 3 or 4 malignant glioma (high grade glioma with molecular features of glioblastoma will be eligible under WHO grade 4 malignant glioma)\n   2. Subgroup #3: Histopathologically confirmed recurrent supratentorial WHO grade 4 malignant glioma (high grade glioma with molecular features of glioblastoma will be eligible under WHO grade 4 malignant glioma) and found amenable for Tumor Monorail Device (TMD) implantation as per the treating neurosurgeon\n2. Patient or partner(s) meets one of the following criteria:\n\n   1. Non-childbearing potential (i.e.) not sexually active, physiologically incapable of becoming pregnant, including people who are post-menopausal or surgically sterile. Surgically sterile people are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation or have had a vasectomy. Postmenopausal for purposes of this study is defined as 1 year without menses.; or\n   2. Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide.\n3. Age ≥ 18 years of age at the time of entry into the study\n4. Karnofsky Performance Score (KPS) ≥ 70%\n5. Hemoglobin ≥ 9 g\u002Fdl prior to biopsy\n6. Platelet count ≥ 100,000\u002Fµl unsupported is necessary for eligibility on the study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000\u002Fµl is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion\n7. Neutrophil count ≥ 1000 prior to biopsy\n8. Creatinine ≤ 1.5 x normal range prior to biopsy\n9. Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)\n10. AST\u002FALT ≤ 2.5 x ULN\n11. Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy. Patients with prior history of thrombosis\u002Fembolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy.\n12. At the time of biopsy, prior to administration of D2C7-IT, the presence of recurrent tumor must be confirmed by histopathological analysis\n13. A signed informed consent form approved by the Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study\n14. Able to undergo brain MRI with and without contrast\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breastfeeding\u002Fchestfeeding\n2. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate\n3. Patients with severe, active co-morbidity, defined as follow:\n\n   1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C)\n   2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection\n   3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)\n   4. Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) \\\u003C 50%) disease or uncontrolled diabetes mellitus\n   5. Patients with albumin allergy\n4. Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks \\[except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\\] prior to starting the study drug unless patients have recovered from side effects of such therapy\n5. Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy\n6. Patients may not have received treatment with tumor treating fields (e.g., Optune) ≤ 1 week prior to starting the study drug\n7. Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation\n8. Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)\n\n   1. If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\n   2. If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial\n9. Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease\n10. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the D2C7-IT infusion\n11. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)\n12. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin\n13. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n14. Only for patients in Subgroup #3 (TMD subgroup): Patients with known allergies to silicone, polyurethane and titanium, which are materials contained in the TMD\n\nSubject Eligibility Salvage Treatment (Effective with Protocol Version v.5.0)\n\nBefore being allowed to proceed with salvage treatment, the subject must satisfy the following inclusion and exclusion criteria. This option is available only for patients treated prior to Protocol Version v.5.0 - Subgroup #1:\n\nInclusion Criteria Salvage Treatment\n\n1. Patients must have a recurrence of their supratentorial WHO grade IV4 malignant glioma based on imaging studies with measurable disease requiring therapy other than per protocol allowed reduced dose bevacizumab\n2. Patients must be ≥ 4 months since their intratumoral administration of D2C7-IT + 2141-V11\n3. A new signed informed consent form for the treatment with 2141-V11 in the CPL area ipsilateral to the tumor approved by the Institutional Review Board (IRB) of record will be required. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of the injection of 2141-V11 in the CPL subcutaneous area.\n4. If the subject is able to produce sperm and is sexually active, they are eligible to enter and receive treatment with 2141-V11 injected in the CPL subcutaneous area if their partner(s) meets the criteria outlined in sub-bullet a. below or if they or their partner(s) are using one of the methods of birth control outlined in sub-bullet b. below. If the subject is potentially able to become pregnant, they are eligible to enter and participate in this study if they meet the following criteria:\n\n   1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including people who are postmenopausal or surgically sterile). Surgically sterile people are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study, is defined as 1 year without menses); or\n   2. Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g., birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g., a condom or diaphragm) used with spermicide.\n   3. Please note: If the patient has had a vasectomy or is using a condom with spermicide, their partner does not need to use additional birth control noted in 4a and 4b.\n5. Total bilirubin ≤ 1.5 x ULN prior to CPL injection (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)\n6. AST\u002FALT ≤ 2.5 x ULN prior to CPL injection.\n7. Neutrophil count ≥ 1000 prior to CPL injection.\n8. Platelet count ≥ 50,000\u002FµL unsupported is necessary prior to CPL injection.\n9. Creatinine ≤ 1.2 x normal range prior to CPL injection.\n\nExclusion Criteria Salvage Treatment\n\n1. Patients who are pregnant or breastfeeding\u002Fchestfeeding\n2. Patients with severe, active co-morbidity, defined as follow:\n\n   1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C)\n   2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection\n   3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)\n   4. Patients with known lung (forced expiratory volume in the first second of expiration \\[FEV1\\] \\\u003C 50%) disease or uncontrolled diabetes mellitus\n3. Karnofsky Performance Score \\\u003C 60%\n4. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the 2141-V11 injection in the CPL area\n5. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months",{"count":85,"type":22},90,[25],"This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.",[42],[90,91,92,36,93,94,95,96,97,98,99,100],"D2C7","D2C7-IT","Glioblastoma","2141-V11","Pro00104852","Duke","Rockefeller","CD40","epidermal growth factor receptor (EGFR)","EGFR","Landi","2026-06-03",{"date":103,"type":55},"2026-06-04",{"date":105,"type":55},"2021-07-09",{"date":107,"type":22},"2028-06",{"name":109,"class":110},"Darell Bigner","OTHER",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100546639","proton-pulsed-reduced-dose-rate-radiotherapy-for-recurrent-cns-malignancies-trial-100546639","NCT06397560","PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial","PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial","POPCORN","Inclusion Criteria:\n\n* Karnofsky performance status ≥ 50\n* Histologically-confirmed or radiographic evidence of recurrent \u002F progressive glioma\n* Prior treatment with radiotherapy to a minimum dose of 45 Gy\n* At least 6 months or greater between completion of prior radiotherapy and enrollment in this study. If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:\n\n  1. New areas of tumor outside the original radiotherapy fields as determined by the investigator.\n  2. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment.\n  3. Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment.\n* Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy\n* Must not be pregnant (positive pregnancy test) or breastfeeding. Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.\n\nHighly effective and acceptable forms of contraception are:\n\n* Male condom plus spermicide\n* Cap plus spermicide\n* Diaphragm plus spermicide\n* Copper T\n* Progesterone T\n* Levonorgestrel-releasing intrauterine system (e.g., Mirena®)\n* Implants\n* Hormone shot or injection\n* Combined pill\n* Mini-pill\n* Patch\n\nIndividuals who meet any of the following criteria will not need contraception:\n\n* Individuals assigned male at birth\n* Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50\n* Radiation-induced oophorectomy with last menses \\> 1 year ago\n* Chemotherapy-induced menopause with \\>1 year interval since last menses\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)\n\nExclusion Criteria:\n\n* Two or more courses of prior radiotherapy\n* Inability to undergo an MRI with contrast\n* Leptomeningeal evidence of recurrent disease\n* Multi-focal disease\n* Any other condition that may put a participant at higher risk, at the discretion of the investigator.",{"count":120,"type":22},28,[122],"NA","The purpose of this research study is to see if a specific type of radiation therapy, called \"proton pulsed reduced dose rate\" or \"PRDR radiotherapy\" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a \"recurrent high-grade glioma\" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.",[36,42,125],"Recurrent Glioma","2026-05-28",{"date":128,"type":55},"2026-06-01",{"date":130,"type":55},"2025-04-30",{"date":132,"type":22},"2029-06",{"name":134,"class":110},"Baptist Health South Florida",2,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":63},"100512623","surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-glioblastoma-100512623","NCT05954858","Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma","Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).\n2. TPFF and\u002For pericranial flap is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n3. Subject intends to participate in another clinical trial\n4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n5. Subject has an active infection requiring treatment.\n6. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n7. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n8. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n9. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":144,"type":22},32,[122],"This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.\n\nThe objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).",[42,92,33,148,41,39,43],"Glioblastoma Multiforme, Adult",[150,151,152,153],"tissue autograft","blood brain barrier","pedicled temporoparietal fascial","pericranial flap",{"date":128,"type":55},{"date":156,"type":55},"2023-06-29",{"date":158,"type":22},"2029-06-30",{"name":160,"class":110},"Northwell Health",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":63},"100514481","omental-tissue-autograft-in-human-recurrent-glioblastoma-multiforme-rgbm-100514481","NCT05979064","Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)","Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).\n2. Omental graft is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject intends to participate in another clinical trial.\n3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.\n10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.\n11. Subject who are unable to have an MRI scan for any reason.",{"count":169,"type":22},10,[122],"This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.",[36,42,92,33,173,39,43,41],"Glioblastoma Multiforme of Brain",[151,175,176,177,178],"omentum autograft","omental autograft","omentum","omental",{"date":128,"type":55},{"date":181,"type":55},"2023-04-04",{"date":183,"type":22},"2028-04",{"name":160,"class":110},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":63},"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":193,"type":22},432,[195],"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.",[92,33,42,39,43,198,148],"Glioblastoma, IDH-wildtype",{"date":128,"type":55},{"date":201,"type":55},"2022-04-27",{"date":203,"type":22},"2028-04-01",{"name":160,"class":110},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":63},"100564975","early-phase-1-window-of-opportunity-study-of-dsp-0390-in-gliomas-100564975","NCT06636162","Window of Opportunity Study of DSP-0390 in Gliomas","Early Phase 1 Window of Opportunity Study of Oral DSP-0390 in Gliomas","Inclusion Criteria\n\n* Patients must have either newly diagnosed and suspected glioma per radiographic features, or radiographic recurrence of a histologically confirmed IDH-mutant glioma with the following grade requirements:\n\n  * ARM A: suspected lower grade glioma, or histologically confirmed grade II IDH-mutant glioma OR\n  * ARM B: suspected high grade glioma, or histologically confirmed grade III or IV glioma.\n* Patient must be a candidate for surgical resection\n* At least 18 years of age.\n* Karnofsky ≥ 70%\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm (patient may not use G-CSF or GM-CSF to achieve this ANC level)\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9 g\u002FdL (patient may not receive transfusion or use erythropoietin to obtain this Hgb level)\n  * Total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with known Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), or activated partial thromboplastin time (aPTT) ≤1.5 x ULN. The use of anticoagulants is permitted as long as the PT\u002F(a)PTT is within therapeutic limits (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to Day 1.\n  * Creatinine Clearance of ≥40 mL\u002Fmin per Cockroft-Gault formula or by a 24 hour urine.\n* If a patient is using an antiepileptic medication, the patient is on a stable dose and without seizures for 14 days prior to Day 1. The antiepileptic medication used must not fall under any prohibited therapy category as defined in the protocol.\n* If the patient is receiving corticosteroids at baseline, the dose administered is stable or decreasing for at least 5 days prior to Day 1. A higher stable dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the sponsor-investigator.\n* The effects of DSP-0390 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (2 forms of acceptable contraception, including one barrier method) prior to study entry, for the duration of study participation, and for 6 months after the last dose of DSP-0390. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria\n\n* Patient has had prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to Day 1.\n* Patient has multifocal disease, leptomeningeal metastasis, or extracranial metastasis.\n* Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \\>450 msec for males and \\>470 msec for females); and\u002For the patient has a history of Torsade de Pointes.\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other condition that may limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Patient is known to have active Crohn's or other inflammatory bowel disease.\n* A history of other malignancy for which all treatment was completed at least 2 years before Day 1 and the patient has no evidence of disease. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, and superficial bladder cancer that has been removed or curatively treated.\n* On active treatment for other, unrelated malignancy or currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390.\n* Patient has taken concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, and other strong or moderate CYP3A4 inhibitors or inducers, and strong CYP2D6 inhibitors within 1 week or 5 half-lives (whichever is greater) prior to Day 1 or expects to use them during the study. Note both oral and IV ondansetron at doses ≤ 8mg q6 hours are permitted.\n* The presence of any active retinal abnormality determined by screening ophthalmologic examination.\n* Patient has significant cardiovascular disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, pectoris, clinically significant cardiac arrhythmias, or stroke in the preceding 6 months prior to Day 1.\n* Uncontrolled intercurrent illness including, but not limited to, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, disorders associated with significant immunocompromised state, or ongoing or active infection.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of DSP-0390.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended, as long as the ART agents do not fall under exclusion #8.\n* Patient has a known detectable viral load for hepatitis C, or evidence of a hepatitis B surface antigen.\n* Patient has had a major non-neurologic surgical procedure, surgical resection, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1 or anticipates needing a major surgical procedure during the course of the study.\n* Patient has had a minor surgical procedure, fine needle aspirations, or core biopsies within 7 days prior to Day 1.\n* Patient has received chemotherapy or investigational anticancer therapy within 4 weeks (except 6 weeks for nitrosoureas and immunotherapy, or 8 weeks for an implanted nitrosoureas wafer) prior to Day 1.\n* Patient has had radiotherapy within 12 weeks prior to Day 1, unless relapse is confirmed by tumor biopsy.",{"count":213,"type":22},20,[215],"EARLY_PHASE1","This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant glioma undergoing tumor resection. Tissue will be collected during surgical resection. Blood will be drawn at various time points throughout the 2 weeks of treatment. The hypothesis is that DSP-0390 will accumulate in brain tumor tissue at pharmacologically relevant concentrations, and that alterations in cholesterol metabolism driven by mutant IDH will increase susceptibility to DSP-0390 and lead to tumor cell death.",[42,218],"IDH Mutation",[220,221,222,223,224,225],"DSP-0390","IDH-mutant glioma","brain tumor","brain cancer","low grade glioma","high grade glioma","2026-04-30",{"date":228,"type":55},"2026-05-06",{"date":230,"type":55},"2025-04-03",{"date":232,"type":22},"2027-05-17",{"name":234,"class":110},"Washington University School of Medicine",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":252,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":63},"100481940","early-phase-1-evaluation-of-18f-fluciclovine-positron-emission-tomography---magnetic-resonance-imaging-pet-mri-in-lgg-100481940","NCT05555550","Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG","Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)","Inclusion Criteria\n\n1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.\n2. Participants must have evaluable disease (1x1 cm tumor on MRI)\n3. Scheduled to receive systemic therapy for LGG\n4. Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration\n6. Being on a treatment regimen does not exclude a subject from enrollment.\n\nExclusion Criteria\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Pregnant participants\n3. Participants who weigh less than 8 kg.\n4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.\n5. Participants with a history of abnormal kidney function or creatinine \\>= CTCAE v5.0 grade 2 at time of study registration.\n6. Participants with primary tumors of the spinal cord.","1 Year","21 Years",{"count":245,"type":22},30,[215],"The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.",[36,249,250,42,251],"Low-grade Glioma","Low Grade Glioma of Brain","Glioma Intracranial",[36,249,250,42,251,253],"18F-Fluciclovine","2026-04-24",{"date":256,"type":55},"2026-04-29",{"date":258,"type":22},"2026-07-29",{"date":260,"type":22},"2027-09",{"name":262,"class":110},"Children's Hospital of Philadelphia",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":281,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":297},"100578380","phase-1-safety-and-tolerability-of-tng456-alone-and-in-combination-with-abemaciclib-in-patients-with-solid-tumors-with-mtap-loss-100578380","NCT06810544","Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss","A Phase 1\u002F2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss","Inclusion Criteria:\n\n* Has a tumor with a confirmed MTAP loss\n* Is ≥18 years of age at the time of signature of the main study ICF\n* Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate.\n* Is able to swallow tablets\n* Adequate Organ function\u002Freserve per local labs\n* Negative serum pregnancy test result at screening\n* Has an ECOG performance status score of 0 to 1\n* Has measurable disease based on RECIST v1.1 or a confirmed glioblastoma (IDH-wildtype) with radiographic evidence of disease progression or recurrence defined by RANO 2.0.\n* Has an ECOG performance score of 0 to 1 or for GBM has a Karnofsky performance status score ≥70.\n\nExclusion Criteria:\n\n* A female patient is who is pregnant or breastfeeding\n* Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)\n* Has an active infection requiring systemic therapy\n* Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor\n* Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4\u002F6 inhibitor\n* Clinically relevant cardiovascular disease\n* Has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol",{"count":271,"type":22},191,[25,26],"This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.",[275,276,42,277,278,279,280],"Non Small Cell Lung Cancer","Glioma Glioblastoma Multiforme","Solid Tumor","Non-Small Cell Adenocarcinoma","Lung Cancer","Brain Tumor",[282,283,284,285,286],"MTAP","PRMT5 inhibitor","CDK 4\u002F6","abemaciclib","Tango","2026-04-10",{"date":289,"type":55},"2026-04-13",{"date":291,"type":55},"2025-03-24",{"date":293,"type":22},"2027-09-30",{"name":295,"class":296},"Tango Therapeutics, Inc.","INDUSTRY",15,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":135},"100586631","phase-1-cue-102-in-recurrent-glioblastoma-100586631","NCT06917885","CUE-102 in Recurrent Glioblastoma","Phase Ib Open-label Study of Adjuvant CUE-102, a WT-1-pHLA-IL2-Fc Fusion Protein in Glioblastoma (GBM) Patients at First Recurrence","Inclusion Criteria:\n\n* Have HLA-A\\*0201 genotype as determined by genomic testing performed locally;\n* Have histologically confirmed World Health Organization (WHO) Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence. Patients with gliosarcoma are NOT eligible;\n* Be willing and able to provide written informed consent\u002Fassent for the trial;\n* Be ≥ 18 years of age on day of signing informed consent;\n* Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A);\n* Participants must be at least 4 weeks from start of last chemotherapy cycle (at least 6 weeks for nitrosoureas and at least 1 week for metronomic dosing) and at least 4 weeks or 5 half-lives (whichever is shorter) for any prior investigational agent. There is no minimal time from cessation of Optune TTF nor for prior cancer vaccine therapy.\n* MRI within 14 days prior to registration. MRIs should include vascular imaging when possible. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI scan and the start of treatment, a new baseline MRI or CT is required;\n* Patients must have fully completed initial radiation therapy with or without daily temozolomide including 60 Gy in 30 fractions, 59.4 Gy in 1.8 Gy per fraction or equivalent;\n* At least 12 weeks from completion of radiotherapy +\u002F- temozolomide. Patients \\\u003C 12 weeks from the completion of radiation therapy may be eligible if they have either of the following: 1) histopathologic confirmation of recurrent tumor; or 2) new contrast enhancing disease outside the primary radiation field. Participants who have received investigational therapies as a component of treatment for newly diagnosed GBM as long as remaining eligibility criteria are satisfied;\n* Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (exceptions include alopecia, laboratory values listed per inclusion criteria, and lymphopenia, which is common after therapy with temozolomide);\n* Participants must meet the following organ and marrow function as defined below, all screening labs should be performed within 14 days of registration:\n\n  * Absolute neutrophil count (ANC) ≥1,500 \u002FmcL\n  * Platelets ≥100,000 \u002F mcL\n  * Hemoglobin ≥9 g\u002FdL or ≥5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)\n  * Serum creatinine ≤ 1.5 X institutional ULN OR\n  * Measured or calculated creatinine clearance (CrCl) ≥45 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN (CrCl should be calculated per institutional standard, GFR can also be used in place of creatinine or CrCl)\n  * Serum total bilirubin ≤ 1.5 X institutional ULN OR\n  * Direct bilirubin ≤ institutional ULN for participants with total bilirubin levels \\> 1.5 X institutional ULN\n  * AST (SGOT) and ALT (SGPT) ≤ 3.0 X institutional ULN OR ≤ 5 X institutional ULN for participants with Gilberts syndrome\n  * International Normalized Ratio (INR) OR Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 X institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * Resting baseline oxygen saturation by pulse oximetry ≥92% at rest\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative urine or serum pregnancy within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;\n\n  --Women in the following categories are not considered WOCBP:\n  * Premenarchal\n  * Premenopausal female with 1 of the following:\n\n    * Documented hysterectomy\n    * Documented bilateral salpingectomy\n    * Documented bilateral oophorectomy\n    * Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.\n  * Postmenopausal female\n\n    * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n      -----A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.\n    * Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n* Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study treatment discontinuation or the initiation of other cancer therapy (whichever is shorter);\n\n  * Highly Effective Contraceptive Methods That Are User Dependent a (Failure rate of \\\u003C 1% per year when used consistently and correctly.)\n  * Combined (estrogen- and progestogen- containing) hormonal contraception\n\n    * i. Oral\n    * ii. Intravaginal\n    * iii. Transdermal\n    * iv. Injectable\n  * Progestogen-only hormonal contraception\n\n    * v. Oral\n    * vi. Injectable\n  * Highly Effective Methods That Have Low User Dependency (Failure rate of \\\u003C1% per year when used consistently and correctly)\n\n    * Progestogen- only contraceptive implant\n    * Intrauterine hormone-releasing system (IUS) Intrauterine device (IUD)\n    * Bilateral tubal occlusion\n    * Vasectomized partner (A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used).\n    * Sexual abstinence (Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant).\n    * NOTES: Use should be consistent with local regulations regarding the use of contraceptive methods for participants of clinical studies.\n\n      * a. Typical use failure rates are lower than perfect-use failure rates (i.e. when used consistently and correctly).\n      * b. If hormonal contraception efficacy is potentially decreased due to interaction with study treatment, condoms must be used in addition to the hormonal contraception during the treatment period and for at least during study treatment and for 120 days after study treatment discontinuation after the last dose of study treatment or the initiation of other cancer therapy (whichever is shorter).\n      * c. If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive implants are limited to those which inhibit ovulation.\n* Male participants must agree to use at least one of the following methods of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy or the initiation of other cancer therapy (whichever is shorter):\n\n  * Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent\n  * Use a male condom plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.\n\n    * a. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.\n\nExclusion Criteria:\n\n* Received any therapy for tumor recurrence other than surgery;\n* More than one episode of recurrent or progressive tumor;\n* Is currently participating or plans to participate in another study of an investigational agent or using an investigational device.\n* Tumor primarily localized to the brainstem or spinal cord;\n* Presence of multifocal tumor, bi-hemispheric tumor (radiographic evidence of tumor extending from one hemisphere into the other through the corpus callosum), diffuse leptomeningeal or extracranial disease;\n* Has a diagnosis of immunodeficiency;\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. Examples include - but are not limited to - unstable angina pectoris, cardiac arrhythmia or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements;\n* Has history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of enrollment;\n* Has evidence of intratumoral or peritumoral hemorrhage on baseline MRI scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans;\n* Has gastrointestinal bleeding or any other hemorrhage\u002Fbleeding event CTCAE Grade \\> 3 within 6 months of enrollment;\n* Has a known additional malignancy that is progressing or requires active treatment within 1 year of start of study drug, except for those treated with surgical therapy only (e.g. basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy);\n* Has active autoimmune disease requiring systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg thyroxine, insulin, or physiologic corticosteroid replacement for adrenal insufficiency or pituitary\u002Fhypothalamic dysfunction, etc.) is not considered a form of systemic treatment;\n* Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis;\n* Has an active infection requiring systemic therapy within 7 days before enrollment;\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;\n* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies) and is receiving antiretroviral therapy.\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected);\n* Has a history of non-healing wounds or ulcers, or bone refractures within 3 months of fracture;\n* Has a history of arterial thromboembolism within 12 months of enrollment;\n* Has had clinically significant cardiovascular disease within 12 months of start of study drug, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty\u002Fstent;\n* Has a known history of active TB (Bacillus Tuberculosis);\n* Has a known hypersensitivity to any of the study therapy products and\u002For any of their excipients;\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment or the initiation of other cancer therapy (whichever is shorter). Pregnant women are excluded because there is an unknown but potential risk for adverse events affecting a developing fetus and\u002For the mother secondary to treatment with CUE-102. There is also an unknown but potential risk for adverse events affecting nursing infants secondary to treatment of the mother with CUE-102, thus, breastfeeding must be discontinued if the mother is treated with CUE-102;\n* Is receiving any form of immunosuppressive therapy (e.g. chronic systemic steroid therapy exceeding dosage of 10 mg daily of prednisone equivalent) within 7 days prior to enrollment;\n* Has received systemic immunosuppressive treatments, aside from systemic corticosteroids (such as methotrexate, chloroquine, azathioprine, etc), within six months of enrollment;\n* Requires treatment with high dose systemic corticosteroids defined as dexamethasone \\> 2 mg\u002Fday or bioequivalent for at least 3 consecutive days within 2 weeks of enrollment;\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n  * Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption).\n  * Physiologic replacement doses of systemic corticosteroids are permitted, ≤10 mg\u002Fday prednisone equivalents.\n  * A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n* Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to enrollment; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed;\n* Has received a live vaccine within 30 days prior to enrollment;\n\n  * Examples of live vaccines include - but are not limited to - the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* History of acute pancreatitis within 3 months before enrollment;\n* Diverticulitis that is clinically significant in the opinion of the Investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant flares within 4 weeks before enrollment.",{"count":306,"type":22},18,[25],"The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM).\n\nThe name of the study drug involved in this study is:\n\n-CUE-102 (a type of fusion protein)",[29,92,42],[92,29,42],"2026-03-03",{"date":313,"type":55},"2026-03-05",{"date":315,"type":55},"2025-07-30",{"date":317,"type":22},"2028-01-31",{"name":319,"class":110},"David Reardon, MD",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100552060","efficacy-of-a-mixed-distancial-neuropsychological-rehabilitation-program-in-patients-with-grade-2-or-3-diffuse-glioma-100552060","NCT06468176","Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma","Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma : a Randomized Controlled Trial","FREEDOME","Inclusion Criteria:\n\n* Age ≥18 years old, no age limit;\n* Histo-molecular diagnosis of grade 2 or 3 diffuse glioma according to World Health Organization (WHO) Classification 2016, regardless of oncological treatments previously received;\n* Patient in satisfactory general condition for the study, defined by a WHO performance index ≤ 2 (ECOG-Performance Status (PS) ≤ 2);\n* Neurosurgical excision (excluding biopsy) performed ≥ 12 months previously;\n* In the case of oncological treatment, patient who has completed his sessions (radiotherapy, chemotherapy) for ≥ 6 months;\n* Patient presenting a cognitive complaint defined as a response rated at least \"Fairly\" to at least one of the 2 items (n°20 and 25) assessing cognitive complaint in the EORTC QLQ-C30 questionnaire (i.e., defined as a score on the \"Cognitive Functioning\" scale ≤ 66.67);\n* Fluent in French;\n* Affiliation to the French Social Security System;\n* Possible regular use of a digital tool with Internet access;\n* Signature of informed consent prior to any study procedure.\n\nExclusion Criteria:\n\n* Visual or auditory deficit not corrected to normal and\u002For preventing use of computer tools (i.e., homonymous lateral hemianopia is not a criterion for non-inclusion) ;\n* Concurrent participation in a study with cognition as primary endpoint (e.g., \"POLCA\", \" POLO \" clinical trials) ;\n* Legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent form or completing the study ;\n* Unstable or uncontrolled psychiatric syndrome (i.e., psychotropic treatments are not a criterion for non-inclusion if doses are stable) ;\n* Known severe cognitive impairment (e.g., neurodegenerative disease, sequelae of head trauma, etc.) or defined by a score ≤ 20 on the MoCA test or impacting the ability to use digital tools at home ;\n* Oncological treatment (radiotherapy and\u002For chemotherapy and\u002For surgery) planned within 4 months of inclusion. Targeted anti-Isocitrate DeHydrogenase (IDH) therapies are authorized.",{"count":329,"type":22},187,[122],"Diffuse low-grade glioma are rare brain tumors affecting young subjects (median age at diagnosis 38 years for grade 2 and 49 years for grade 3). Cognitive symptoms are common in these patients, including memory, attention and executive function disorders. These disorders may have a deleterious impact on patients' professional, family and social lives, and have a negative impact on their quality of life. The benefits of cognitive rehabilitation have been demonstrated in other neurological pathologies. Furthermore, due to limited access to rehabilitation by neuropsychologists, some studies have evaluated the impact of digital cognitive rehabilitation programs. However, it cannot replace human support.",[42],[334,335,336,337],"Oncology","Neurologic Disorder","Neuropsychological rehabilitation","Diffuse Glioma","2025-12-12",{"date":340,"type":55},"2025-12-19",{"date":342,"type":55},"2024-07-05",{"date":344,"type":22},"2027-12-15",{"name":346,"class":110},"Institut du Cancer de Montpellier - Val d'Aurelle",8,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":243,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":356,"briefSummary":357,"conditions":358,"keywords":359,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":63},"100481748","early-phase-1-18f-fluciclovine-pet-mri-in-high-grade-glioma-100481748","NCT05553041","18F-Fluciclovine PET-MRI in High-grade Glioma","Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)","Inclusion Criteria\n\n* 1\\. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating \\>=2\u002F3 of the pons).\n* 2\\. Measurable disease, measuring at least 1x1 cm.\n* 3\\. Life expectancy of greater than 8 weeks.\n* 4\\. Age \\> 1 years but \\< 21 years of age at enrollment.\n\nFor those without planned surgery:\n\n* 1\\. Participants with clinical and\u002For radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan.\n\nor\n\n* 2\\. Participants with suspicion for TP or PsP on first post-radiation MRI\n\nFor those with planned surgery:\n\n* 1\\. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.\n\nExclusion Criteria:\n\n* 1\\. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n* 2\\. Pregnant or breastfeeding participants.\n* 3\\. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).\n* 4\\. Participants who weigh less than 8 kg.\n* 5\\. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.\n* 6\\. Participants with a history of abnormal kidney function or creatinine \\>= CTCAE v5.0 grade 2 at time of study registration.\n\n  7\\. Participants with primary tumors of the spinal cord.",{"count":245,"type":22},[215],"The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.",[36,41,42,251,337],[36,41,42,251,337,360],"18F fluciclovine","2025-12-03",{"date":363,"type":55},"2025-12-04",{"date":365,"type":55},"2024-08-07",{"date":367,"type":22},"2027-12",{"name":262,"class":110},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":381,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":63},"100611650","phase-1-a-phase-iiia-study-of-c5252-in-patients-with-intracranial-tumor-100611650","NCT07243340","A Phase I\u002FIIa Study of C5252 in Patients With Intracranial Tumor","A Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Herpes Virus C5252 Injection in Patients With Intracranial Tumor","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed recurrent malignant high-grade (WHO grade 3-4) glioma who have received standard therapy and no available treatment.\n* Measurable lesions exist in accordance with RANO criteria.\n* Sufficient space for ≥1 mL drug infused into tumor cavity post resection.\n* Ommaya reservoir has been placed in the operation area, and drug administration conditions are available.\n* Karnofsky Performance Status (KPS) ≥ 60%\n* Life expectancy \\> 12 weeks.\n* No severe hematological, cardiovascular, liver or kidney diseases.\n* If the patient is a sexually active female of childbearing potential or if the patient is a sexually active male whose partner is a female of childbearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of before the C5252 infusion.\n* Capable of understanding and complying with protocol requirements.\n\nKey Exclusion Criteria:\n\n* Inability to undergo MRI examination for any reason.\n* Active hemorrhage observed before enrollment.\n* Imaging test: a. lesion located in non-cerebral regions; b. there are other lesions outside target tumor cavity; c. extra-cranial metastasis.\n* Tumor lesion locates in ventricular system or there is a clear perforation between the tumor cavity and the ventricle after tumor resection.\n* History of encephalitis, multiple sclerosis or other central nervous system infections\n* Treated with steroid hormones and\u002For more than 5 mg dexamethasone per day or other immunosuppressive drugs for systemic treatment within 4 weeks.\n* Persistent or active infection, and cannot be controlled by treatment.\n* Subjects with bleeding tendency or need to take anticoagulant drugs, antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs) and are unable to discontinue.\n* Uncontrolled disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris.\n* Other malignant tumor within 5 years.\n* Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period.\n* In the period of recurrent herpes simplex virus infection, with corresponding clinical manifestations.\n* Systemic use (other than topical) of anti-HSV drugs\n* Prior treatment with any oncolytic virus, cell therapy or gene therapy.\n* Participants have a history of splenectomy, organ transplantation, bone marrow transplantation or stem cell transplantation\n* Prior antitumor treatment with intracranial implants, such as Carmustine.\n* Previous history of allergic reactions to similar biological components such as HSV-1, IL-12 or anti-PD-1 antibodies, or with known allergic reactions to any component of the C5252 prescription, including glycerol.\n* Developed ≥Grade 3 irAE during previous immunotherapy\n* History of frequent drug use (including \"recreational use\") or drug abuse (including alcohol abuse) within one year prior to signing the informed consent form.\n* Other situation that PI consider subjects not appropriate to participate in the study.",{"count":377,"type":22},36,[25,26],"This study includes phase I dose escalation part and phase IIa dose expansion part. The goal of this clinical trial is to learn if C5252 treatment is safe and well tolerated in patients with intracranial tumor and to learn preliminary efficacy of C5252. In this study, participants will be given single or multiple doses of C5252 according to protocol followed by toxicity observation, safety follow-up and long-term follow-up.",[42],"NOT_YET_RECRUITING","2025-11-19",{"date":384,"type":55},"2025-11-21",{"date":386,"type":22},"2025-12-15",{"date":388,"type":22},"2028-12-15",{"name":390,"class":296},"ImmVira Pharma Co. Ltd",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":410,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":63},"100588492","phase-1-imaging-of-solid-tumors-using-18f-trx-100588492","NCT06942104","Imaging of Solid Tumors Using 18F-TRX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Advanced solid tumor malignancy in one of the following cohorts:\n\n  * Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging\n  * Cohort 2 (n = 50):\n\n    * WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging; e.g., enhancing necrotic and\u002For hypervascular intrinsic brain tumor) high grade (WHO grade 3 or 4) glioma (n = 10), Locally advanced or metastatic clear cell renal cell carcinoma with at least three metastatic lesions on conventional imaging (n = 10).\n    * Metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging including cross-sectional imaging of the chest, abdomen and pelvis and whole body bone scan or prostate-specific membrane antigen (PSMA) PET scan (n = 30).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Negative serum or urine pregnancy test (women of childbearing potential only) within 72 hours of baseline procedures.\n* Absolute neutrophil count \\> 1.5 x 10\\^6\u002FL.\n* Platelets \\> 75,000 x 10\\^6\u002FL.\n* Hemoglobin \\> 8 g\u002FdL.\n* Total bilirubin \\\u003C 1.5 x upper limit of normal.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Creatinine clearance \\> 50 ml\u002Fmin, calculated using the Cockcroft-Gault equation.\n\nExclusion Criteria:\n\n* Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.\n* Individuals receiving strong inhibitors or inducers of CYP3A4.\n* Uncontrolled active infection or other medical condition that would preclude safe participation in the study as judged by the Investigator.\n* Individuals who are pregnant.\n\n  * Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of 18F-TRX to the study participant.\n  * A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n* Individuals who are breastfeeding\u002Fchestfeeding.\n\n  * Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of 18F-TRX to the study participant.\n  * Breastfeeding\u002Fchestfeeding should be discontinued before administration of 18F-TRX.",{"count":398,"type":22},56,[25],"This phase I trial tests the safety and effectiveness of 18F-TRX in detecting tumors (cancer) patients with solid tumors. 18F-TRX is an imaging tracer that is used to visualize tumors using a PET scan. It specifically targets and detects labile (unstable) iron levels within tissues, including tumors. Diagnostic procedures, such as 18F-TRX PET\u002FCT or PET\u002FMRI, may help detect tumors in patients with solid tumors",[277,402,403,404,405,406,407,408,409,42],"Solid Carcinoma","Castration-Resistant Prostate Carcinoma","Locally Advanced Clear Cell Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8",[411],"Imaging Studies","2025-07-17",{"date":414,"type":55},"2025-07-18",{"date":416,"type":55},"2025-07-03",{"date":418,"type":22},"2026-09-30",{"name":420,"class":110},"Rahul Aggarwal",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":63},"100456661","phase-1-safety-and-tolerability-of-fb-pmt-in-recurrent-glioblastoma-100456661","NCT05226494","Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma","A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n* Histologically proven intracranial glioblastoma, with first or second recurrence\n* On stable or decreasing dose of steroids, if taken prior to screening\n* Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT\n* Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery\u002Fbiopsy and radiotherapy\n* Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery\n* Life expectancy of more than three months\n* Karnofsky Performance Status of ≥ 70\n* Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication\n* Adequate bone marrow and organ function, confirmed by laboratory testing at screening\n* Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary\n* Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug\n* Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug\n\nExclusion Criteria:\n\n* Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug\n* Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment\n* Prior therapy with fb-PMT or related drugs\n* Currently pregnant or breastfeeding\n* Active infection or serious intercurrent medical illness\n* Surgery of any type within the preceding 28 days that has not fully healed\n* A serious or non-healing wound, ulcer, or bone fracture\n* A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment\n* A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.\n* Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment\n* Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.\n* New York Heart Association classification of heart disease greater than Class 2\n* QTc interval \\> 450 msec in males or \\> 470 msec in females at screening\n* Use of concomitant medications that prolong the QT\u002FQTc interval or risk inducing Torsades de Pointes\n* Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment\n* Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment\n* A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment\n* History of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months\n* History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",{"count":429,"type":22},34,[25],"Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.",[42],[92,33],"2025-05-29",{"date":436,"type":55},"2025-06-04",{"date":438,"type":55},"2022-06-23",{"date":440,"type":22},"2027-10",{"name":442,"class":296},"NanoPharmaceuticals LLC",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":63},"100475718","concurrent-fluorescence-and-sonographically-guided-eradication-of-contrast-enhancing-gliomas-and-metastases-100475718","NCT05474573","Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases","Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial","CONFLUENSE","Inclusion Criteria:\n\n* single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)\n* one or several brain metastases from any cancer\n* newly diagnosed\n* Karnofsky Performance Status 60-100%\n* age 18-79 years\n* performed magnetic resonance imaging with contrast enhancement\n\nExclusion Criteria:\n\n* tumor spreading to corpus callosum or brainstem\n* previously performed brain radiotherapy\n* planned supratotal tumor resection until neurophysiologically revealed eloquent areas\n* known hypersensibility to 5-aminolevulinic or to porphyrin\n* hepatic or renal insufficiency\n* porphyria\n* pregnancy\n* breast feeding","79 Years",{"count":453,"type":22},52,[122],"Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.",[42,457],"Metastases to Brain",[459,460,461,462,463,464,465],"contrast-enhancing glioma","brain metastasis","sonography","ultrasound","fluorescence","5-aminolevulinic acid","5-ALA","2025-05-13",{"date":468,"type":55},"2025-05-16",{"date":470,"type":55},"2022-09-01",{"date":472,"type":22},"2027-08-31",{"name":474,"class":475},"Sklifosovsky Institute of Emergency Care","OTHER_GOV",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":484,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":488,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":381,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":4},"100540942","integrated-analysis-of-therapy-response-and-resistence-in-embryonal-tumors-and-gliomas-100540942","NCT06323408","Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas","Prospective Collection of Clinical and Imaging Data, Radiotherapy Planning and Biomaterials for Integrated Analysis of Therapy Response and Resistance and Detection of Molecular Targets in Adolescents and Young Adults With CNS Tumors","BZKF-AYA","Inclusion Criteria:\n\n1. first diagnosis of high-risk CNS tumors including glioma IDHmutated, medulloblastoma, ependymoma and other intra-axial primary brain tumors\n2. adolescents and young adults (AYA; 15 to 39 years)\n3. Karnofsky status of 60 or higher\n4. resection, extended biopsy or stereotactic biopsy with sufficient tissue volume\n5. multimodal therapy planned at the discretion of the treating specialist\n6. expected survival time of at least 6 months\n7. informed consent from the patient or the patient's legal guardian prior to the first study procedure\n8. complete material collection expected.\n\nExclusion Criteria:\n\n1. synchronous independent tumor disease other than basal cell carcinoma and carcinoma in situ\n2. participation in interventional clinical trial except in standard arms of interventional clinical trials.","15 Years","39 Years",{"count":487,"type":22},72,"OBSERVATIONAL","The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape.",[42,491,492,493],"Embryonal Tumor","Medulloblastoma","Ependymoma",{"date":495,"type":55},"2025-03-25",{"date":497,"type":22},"2025-05",{"date":499,"type":22},"2026-03",{"name":501,"class":110},"University Hospital Regensburg",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":243,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":135},"100529347","phase-2-fet-pet-in-differentiating-tumour-progression-from-pseudoprogression-in-high-grade-glioma-100529347","NCT06172595","FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma","18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas","FET PET in HGG","Inclusion Criteria:\n\n* Men or Women, aged 21 years or older at time of screening\n* Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour\n* With enlarging contrast-enhancing and\u002For T2W\u002FFLAIR-hyperintense lesion(s) on MRI within the previous RT field\n* Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry\n* Subject must consent to undergo all study procedures\n\nExclusion Criteria:\n\n* Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17\n* Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.\n* Proven cerebral metastases\n* IDH-mutated gliomas\n* Pregnancy\u002F breast-feeding",{"count":511,"type":22},22,[26],"The goal of this clinical trial is to evaluate the performance characteristics of O-(2-\\[18F\\]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \\[18F\\]FET-PET in delineating disease. The main question\\[s\\] it aims to answer are:\n\n* whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression\n* whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET\u002FCT of the brain in SGH.",[42],"2024-11-28",{"date":517,"type":55},"2024-12-03",{"date":519,"type":55},"2023-12-21",{"date":521,"type":22},"2026-02-28",{"name":523,"class":110},"Singapore General Hospital",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":63},"100561082","phase-1-clinical-study-on-the-safety-and-efficacy-of-ts-2021-in-the-treatment-of-recurrent-malignant-glioma-100561082","NCT06585527","Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma","A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas","Inclusion Criteria:\n\n* The patient signed the informed consent voluntarily.\n* Age ≥18 years and ≤65 years, male or female.\n* After the initial surgery, the imaging showed that the tumor was completely removed, followed by conventional radiotherapy or (and) chemotherapy, and no recurrence was observed within two months after the end of radiotherapy. The patient had a recurrence of supratentorial high-grade glioma. The pathological diagnosis was glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma recurrence.\n* After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was tumor recurrence at the distant site.\n* With PET\u002FMRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm.\n* KPS score ≥70 before treatment.\n* Normal bone marrow reserve function and normal liver and kidney function: Neutrophil absolute value ≥ 1,500\u002Fmm3, hemoglobin ≥10 g\u002FdL, platelet count ≥100,000\u002Fmm3, total bilirubin level ≤1.5×ULN, glutamic pyruvic transaminase\u002Fglutamic oxalacetic transaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normal and the follow-up compliance was good.\n* Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment.\n\nExclusion Criteria:\n\n* Pregnant or lactating patients.\n* Patients with encephalitis disease, multiple sclerosis, or other CNS (Central Nervous System) infection.\n* Patients with a history of organ transplantation or waiting for organ transplantation.\n* Patients with uncontrolled infectious diseases or other serious diseases, such as HIV positive.\n* Patients with any unstable systemic illness (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 12 months before enrollment, severe arrhythmia requiring medical treatment, liver or kidney failure, etc.)\n* Patients with systemic autoimmune diseases or immunodeficiency diseases.\n* Patients with severe allergic constitution.\n* Patients with chronic diseases requiring long-term treatment with immune agents or glucocorticoids.\n* Patients with mental disorders.","65 Years",{"count":245,"type":22},[25],"The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will :\n\n* Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.\n* Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events.\n\nUsing the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.",[33,42],[537,538,33,42,539,540,541],"Oncolytic Virus","Adenovirus","Ki-67","TGF-β2","IL-15","2024-10-29",{"date":544,"type":55},"2024-10-31",{"date":546,"type":55},"2024-08-29",{"date":548,"type":22},"2026-01-01",{"name":550,"class":110},"Beijing Neurosurgical Institute",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":381,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":573,"locationsCount":63},"100535914","phase-1-niraparib-and-temozolomide-in-patients-glioblastoma-100535914","NCT06258018","Niraparib and Temozolomide in Patients Glioblastoma","A Phase I-II Study of Niraparib Plus Temozolomide \"One Week on, One Week Off\" in Patients With Recurrent Isocitrate Dehydrogenase (IDH) Wild Type Glioblastoma and IDH Mutant Gliomas.","ONC-2022-001","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Ability to understand and willingness to sign an ethics committee approved written informed consent document (or that of legally authorized representative, if applicable).\n3. Patients with diagnosis of recurrent\\\\progressive IDH wild-type GBM (WHO 2021, grade 4). All the GBM histological variants are allowed.\n4. Patients with diagnosis of recurrent\u002Fprogressive IDH mutant gliomas (WHO 2021, grade 2-4). Both astrocytoma and oligodendroglioma may be included.\n5. Both MGMT methylated and unmethylated patients are allowed.\n6. Unequivocal evidence of tumor progression with at least one target lesion based on MRI scan according to Response Assessment in Neuro-Oncology criteria (RANO) or low-grade gliomas (LGGs) Response Assessment in Neuro-Oncology (RANO) criteria for non-enhancing tumors\n7. Patients with IDH wild-type GBM (WHO grade 4) must have received at least the standard front-line therapy defined as below:\n\n   \\- Surgery (biopsy alone is allowed), concomitant radio-chemotherapy (hypo-fractionated regimens are allowed) and maintenance temozolomide chemotherapy (up to 6 cycles completed).\n8. Patients with IDH mutant gliomas (WHO 2021 grade 2-4, both astrocytoma and oligodendroglioma may be included) must have received at least:\n\n   \\- Surgery (biopsy alone allowed), radiotherapy (hypo-fractionated regimens allowed) and\u002For one chemotherapy line \\[temozolomide, Procarbazine (PC) scheme\\].\n9. Enrollment of patients after salvage surgery for recurrent disease is allowed if point number 6 is matched.\n10. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky performance status of ≥ 70.\n11. Life expectancy \\> 12 weeks.\n12. Ability to swallow intact solid oral dosage form (without chewing, crushing, or opening).\n13. Normal bone marrow and organ function as defined below:\n\n    Neutrophils ≥ 1500\u002Fmm3 Platelets ≥ 150x103\u002Fmm3 Hemoglobin ≥ 9.0 g\u002FdL Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula) Aspartate aminotransferase (AST) ≤ 2 x ULN Alanine aminotransferase (ALT) ≤ 2 x ULN Bilirubin≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n14. international normalized ratio (INR) ≤ 1.5 x ULN\n15. partial thromboplastin time (PTT) ≤ 1.5 x ULN\n16. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    Is not a woman of childbearing potential (WOCBP). or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), from the Screening Visit through at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment (see also Appendix A).\n\n    A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours prior to the first dose of study treatment. (The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy).\n17. A male participant of reproductive potential is eligible to participate if he agrees to the following starting with the first dose of study treatment through at least 90 days (a spermatogenesis cycle) after the last dose of study treatment:\n\nrefrain from donating sperm plus, either: be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a WOCBP who is not currently pregnant\n\nExclusion Criteria:\n\n1. 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 subject to receive the planned therapy (including brain surgery), or interfere with the interpretation of study results.\n2. Anticancer treatment within the last 14 days before the start of trial treatment, for example chemotherapy, radiotherapy, immunotherapy. A shorter interval can be approved by the principal investigator, if deemed appropriate.\n3. Previous G4 hematological toxicity (anemia, neutropenia, thrombocytopenia) during concomitant and\u002For adjuvant TMZ treatment.\n4. Previous treatment with a PARP inhibitor.\n5. Presence of diffuse and unequivocal leptomeningeal or extra-cranial disease.\n6. Steroid therapy with dexamethasone \\> 4 mg daily.\n7. Chronic (at least 4 weeks) use of drugs with known risk of QT prolongation.\n8. Use of anticoagulant agents at therapeutic dose (e.g. Low-molecular-weight heparin ( LWMH), new anti-coagulation oral drug (NAO) , Warfarin). Prophylactic dose is allowed. Antiplatelet agents are allowed.\n9. Known primary immunodeficiency or active HIV.\n10. Known active or chronic viral hepatitis indicated by positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA).\n11. Clinically significant cardiovascular disease within 6 months prior to enrollment (or randomization), including:\n\n    Prior events including myocardial infarction, pericardial effusion, and myocarditis.\n\n    Prior cardiac arrhythmia including atrial fibrillation and atrial flutter or requiring concurrent use of drugs or biologics with pro-arrhythmic potential.\n\n    New York Heart Association (NYHA) Class II or greater heart failure. If cardiac function assessment is clinically indicated or performed, an Ejection fraction (LVEF) less than normal per institutional guidelines, or \\\u003C 55%, if threshold for normal is not otherwise specified by institutional guidelines.\n\n    corrected QT interval (QTc) prolongation \\> 470 millisecond or other significant ECG abnormality noted within 14 days of treatment.\n\n    Uncontrolled hypertension, hypertensive crisis, history of hypertensive encephalopathy or history of posterior reversible encephalopathy syndrome (PRES).\n\n    Clinically significant peripheral vascular disease or vascular disease, including rapidly growing aortic aneurysm or abdominal aortic aneurysm \\> 5 cm or aortic dissection.\n\n    Unstable angina.\n12. Patients with a history of cerebrovascular accident or transient ischemic attack within 6 months prior to study enrollment are not eligible.\n13. Evidence of hemorrhage on the baseline MRI or CT scan other than those that are ≤ grade 1 and either post-operative or stable on at least two consecutive scans.\n14. Active diverticular disease of active and\u002For uncontrolled inflammatory bowel disease (IBD).\n15. Gastrointestinal disorders that would impact on drug absorption.\n16. Prior history of myelodysplastic syndrome (MDS) and\u002For myeloid acute leukemia (AML).\n17. Other invasive malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only.\n18. History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.\n19. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n20. Participant is at an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to start of study treatment).\n21. Participant has received a live vaccine within 28 days of planned start of study therapy. Coronavirus Disease 19 (COVID19) vaccines that do not contain live viruses are allowed.\n22. Participants have received a transfusion (platelets or red blood cells), colony-stimulating factors (e.g., granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment.\n23. Participants must not have had radiotherapy encompassing \\> 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.\n24. Women who are breast-feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG).\n25. Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study and unsterilized males not willing to abide by requirements for contraception.",{"count":560,"type":22},86,[25,26],"The study evaluates safety, tolerability, pharmacokinetics at recommended phase II dose (RP2D) and preliminary antitumor activity of Niraparib + dd-TMZ \"one week on, one week off\" in patients affected by recurrent GBM IDH wild-type and recurrent IDH mutant (WHO grade 2-4) gliomas.\n\nThe treatment will be administered until progressive disease, unacceptable toxicity, consent withdrawal, lost to follow-up or death.\n\nThe entire study is expected to last approximately 40 months.",[42],[36,565,566],"Niraparib","Temodal","2024-08-28",{"date":569,"type":55},"2024-08-30",{"date":571,"type":22},"2024-09",{"date":260,"type":22},{"name":574,"class":110},"Armando Santoro, MD",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":488,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":381,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":63},"100554480","in-vitro-models-from-pediatric-brain-tumors-100554480","NCT06499636","In Vitro Models From Pediatric Brain Tumors","In Vitro Models Derived From Pediatric Glial Tumors and Pediatric Embryonal Tumors for Drug Testing and Molecular Studies","PBTS23","Inclusion Criteria:\n\n* Children and young adults who undergo standard surgical resection for suspected primary brain tumors or recurrent brain tumors\n* signed written informed consent\n\nExclusion Criteria:\n\n* no informed consent","35 Years",{"count":585,"type":22},100,"Tumors of the Central Nervous System (CNS) represent the leading cause of cancer-related deaths in children. Current treatment options are not curative for most malignant histologies, and intense preclinical and clinical research are necessary to develop more effective therapeutic interventions against these tumors, most of which meet the FDA definition for orphan diseases. The majority of malignant CNS tumors in children and adolescents belong to two broad histologic tumor entities: those of glial origin, such as high-grade glioma (HGG)and ependymoma (EPN), and those of neuronal origin, also identified as embryonal tumors, that include medulloblastoma and AT\u002FRT(1). Over the last few years, whole-genome sequencing, gene-expression profiling and genome-wide methylation studies have greatly deepened our understanding of the biology and genetics of these tumors, allowing for robust stratification in clinically relevant molecular subgroups. The advancement of single-cell omics over the last decade have highlighted the enormous heterogeneity of tumors, a complex mixture of co-existing cancer subclones and supportive normal cell populations.\n\nHowever, current treatments have remained largely static, and 5-year survival rate for children with malignant CNS tumors only achieves a modest 57.5%.\n\nMore effective treatment strategies should include novel chemotherapeutic agents that take into account high intrinsic tumor heterogeneity as well as the complex regulations of transcriptional and translational mechanisms that control protein expression. Identification of novel drugs and treatment strategies is further limited by the paucity of appropriate preclinical models, which mirror the molecular characteristics of distinct tumor subgroups.\n\nWe propose to establish patient-derived in vitro models to predict chemotherapeutic drug sensitivity\u002Fresistance in malignant pediatric CNS tumors. Next, we propose to perform molecular analyses in tissues of pediatric CNS tumors to determine whether in vitro findings have clinical correlates.",[42,493,492],"2024-07-08",{"date":590,"type":55},"2024-07-12",{"date":592,"type":22},"2024-09-01",{"date":158,"type":22},{"name":595,"class":110},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":63},"100545424","personalized-rendering-of-motor-system-functional-plasticity-potential-to-improve-glioma-resection-and-quality-of-life-100545424","NCT06381726","Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life","Inclusion Criteria (ARM 1):\n\n* Patients signing informed consent for participation in the study\n* Males and females\n* Age ≥ 18 years\n* Patients with lower-grade gliomas with involvement of the motor pathways who are candidates for surgery\n\nInclusion Criteria (ARM 2\u002F3\u002F4):\n\n* Patients signing informed consent for participation in the study\n* Males and females\n* Age ≥ 18 years\n* Patients with lower-grade gliomas treated over two years with tumors only biopsied and\u002For partially resected and eligible for second surgery\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to adhere to standard study controls\n* Subjects unable to understand and freely provide consent to the study",{"count":603,"type":22},400,[122],"Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT\u002FSTR.\n\nHypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and\u002For by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.\n\nAims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and\u002For chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR\u002FSTR preserving hand dexterity.\n\nExperimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and\u002For chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.\n\nExpected Results\n\n1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.\n2. Identify demographic, clinical and imaging variables associated with functional reorganization.\n3. Describe the gain induced by up-front treatment.\n4. Distinguish \"patterns\" predicting chance for GTR\u002FSTR from \"patterns\" suggesting need for up-front treatment.\n\nImpact On Cancer Results will increase the achievement of GTR\u002FSTR, preserving motor integrity, with dramatic impact on LGGs natural history.",[36,42],[36,608,609,610,611,612,613,614,615,616,617,618,619,620],"Neurosurgery","Chemotherapy, Neoadjuvant","Motor Rehabilitation","Magnetic Resonance Imaging","Diffusion Magnetic Resonance Imaging","Resting State Functional Magnetic Resonance Imaging","Functional Magnetic Resonance Imaging","Functional Connectomics","Structural Connectomics","Neuronal Plasticity","Higher Nervous Activity","Neurological Rehabilitation","Antineoplastic Protocols","2024-04-18",{"date":623,"type":55},"2024-04-24",{"date":625,"type":55},"2024-03-07",{"date":627,"type":22},"2028-02-28",{"name":629,"class":110},"University of Milan",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":637,"phases":4,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":640,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":644,"locationsCount":63},"100466636","glioblastoma-and-individualized-therapies-100466636","NCT05356312","Glioblastoma and Individualized Therapies","Retrospective Analysis of Glioblastoma Patients With Immune Therapies","Inclusion Criteria:\n\n* malignant glioma, IDH WT\n\nExclusion Criteria:\n\n* na","EXPANDED_ACCESS","The treatment of patients with World Health Organization (WHO) grade 4 malignant glioma has not seen any significant breakthrough the past years. Following surgery and radio \u002F chemotherapy patients still experience a very high recurrence risk and the prognosis is dismal. The investigators observed patients with grade IV malignant glioma receiving individualized treatment based on their molecular profile including fully personalized vaccines.",[42],"AVAILABLE","2024-02-29",{"date":643,"type":55},"2024-03-01",{"name":645,"class":110},"Zentrum fur Humangenetik Tuebingen",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":488,"phases":4,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":63},"100531722","monitoring-of-patients-with-diffuse-gliomas-using-circulating-mirnas-100531722","NCT06203496","Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs","GliomiR","Inclusion Criteria:\n\n* Major patient\n* Grade 4 diffuse glioma\n* Surgery in the neurosurgery department of Caen University Hospital\n* Patient affiliated to a social security scheme\n* Patient followed at Caen University Hospital\n* No opposition from patient\n\nExclusion Criteria:\n\n* \\- Patients who underwent biopsy (lack of material for study, limited interest of monitoring for these patients without surgical excision).\n* Patients with grade 1 circumscribed glioma or grade 2 or 3 diffuse glioma.\n* Other non-glial histologies, glioneuronal histology\n* Minor patients\n* Patient not affiliated to a social security scheme\n* A minor under guardianship or protection\n* Patient opposed to study",{"count":654,"type":22},60,"MicroRNAs are small non-coding RNAs involved in the post-transcriptional regulation of genes and, consequently, of intracellular signalling pathways that govern cellular behaviour (Komatsu et al., 2023). They are widely implicated in oncogenesis, and in particular in mechanisms promoting cell migration, invasion and proliferation (Romano et al., 2021). Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumor rates in gliomas (Jones et al., 2021; Levallet et al., 2022; Morokoff et al., 2020). Morokoff's study showed encouraging but insufficient results on the possibility of using microRNAs to differentiate radionecrosis versus recurrence. These results need to be consolidated prospectively, with homogeneous samples taken from all patients.\n\nThe aim of this study is to describe the evolution over time of plasma levels of pro-oncogenic microRNAs, after surgery for grade 4 glioma, in order to assess whether they can be used to identify false-positive recurrences on MRI (radionecrosis).",[42],[92,36,658,659],"Biomarker","Radionecrosis","2024-01-03",{"date":662,"type":55},"2024-01-12",{"date":664,"type":22},"2024-01-01",{"date":666,"type":22},"2026-12-31",{"name":668,"class":110},"University Hospital, Caen"]