[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-high-grade-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-high-grade-glioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,68,108,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100492928","phase-1-a-study-of-temodar-with-abexinostat-pci-24781-for-patients-with-recurrent-glioma-100492928",false,"NCT05698524","A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma","A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma","Inclusion Criteria:\n\n* Pathologically proven diagnosis of high grade (aka grade III or IV) glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma)\n* Prior radiation therapy and standard temozolomide; additional therapies for previous progressions are eligible (prior bevacizumab and Optune are allowed)\n* Three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression\n* 19 years of age or older (the age of consent in Nebraska)\n* Fully recovered from any toxicity of prior therapy that, in the opinion of the investigator, could impact tolerance to the study drug\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Adequate bone marrow reserve (ANC count ≥1,500\u002Fmm3, hemoglobin \\> 8 g\u002FdL, platelet count ≥100,000\u002Fmm3)\n* Adequate renal function (a serum creatinine that is at or below 2.0 mg\u002FdL)\n* Adequate hepatic function (serum AST and ALT less than 1.5 times the upper limits of normal, serum alkaline phosphatase less than 2.5 times the upper limits of normal)\n* Able to provide written, informed consent\n* Females of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and\u002For both ovaries)\n* Females of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and up to 6 months following treatment\n\nExclusion Criteria:\n\n* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral PCI-24781\u002FAbexinostat, or put the study outcomes at undue risk\n* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \\> 20 mg\u002Fday) or experimental therapy (other than PCI-24781\u002FAbexinostat PO) within 4 weeks before first dose of study drug\n* Concurrent use of enzyme-inducing antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, felbamate, topiramate and oxcarbazepine)\n* Any other active malignancy other than nonmelanoma skin cancer or controlled prostate cancer\n* Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection (no testing is required for eligibility)\n* Creatinine \\> 1.5 x institutional upper limit of normal (ULN); total bilirubin \\> 1.5 x ULN (unless from Gilbert's disease), and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 x ULN\n* Pregnant or breast-feeding\n* Baseline ECG duration of the ventricular action potential corrected for heart rate (QTc interval) prolongation based on Fridericia's formula is \\> 450 ms in males and \\> 470 ms in females\n* Concomitant valproic acid use, or another histone deacetylases (HDAC) inhibitor\n* Receiving treatment with following medications and unable to discontinue treatment or switch medications prior to study enrollment:\n\n  * Amiodarone (Cordarone, Pacerone)\n  * Arsenic trioxide (Trisenox)\n  * Chlorpromazine (Aralen)\n  * Cisapride (Propulsid)\n  * Clarithromycin (Biaxin)\n  * Disopyramide (Norpace)\n  * Dofetilide (Tikosyn)\n  * Doperidol (Inapsine)\n  * Erythromycin (EryTab, Erythrocin)\n  * Flecanide (Tambocor)\n  * Haloperidol (Haldol)\n  * Ibutilide (Corvert)\n  * Methadone (Methadose, Dolophine)\n  * Moxifloxacin (Avelox)\n  * Pentamidine (Pentam, Nebupent)\n  * Pimozide (Orap)\n  * Procainamide (Procan, Pronestyl)\n  * Quinidine (Cardioquin, Quinaglute)\n  * Sotalol (Betapace)\n  * Thioridazine (Mellaril)\n  * Vandetanib (Zactima)","ALL","19 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781\u002FAbexinostat with metronomic temozolomide.",[26,27,28,29,30],"Recurrent High Grade Glioma","Anaplastic Astrocytoma","Anaplastic Oligodendroglioma","Glioblastoma","Gliosarcoma","RECRUITING","2026-04-13",{"date":34,"type":35},"2026-04-17","ACTUAL",{"date":37,"type":35},"2023-06-26",{"date":39,"type":20},"2029-07",{"name":41,"class":42},"University of Nebraska","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100525823","phase-1-open-label-study-to-evaluate-the-safety-tolerability-and-efficacy-of-the-oncolytic-hsv1-mvr-c5252-100525823","NCT06126744","Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252","The PuMP Trial: \"A Multistage Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252 in Patients With Recurrent High-Grade Glioma\"","PuMP","Inclusion Criteria:\n\n1. Age \\>18 years of age\n2. Disease recurrence of at least 1x1cm and a maximum of 3x3cm of enhancing tumor:\n\n   Dose escalation portion: patients with recurrent high-grade glioma, IDH wt or IDH mutated, grade 3 or grade 4 based on imaging.\n\n   Dose expansion portion: Recurrent, IDH wt, glioblastoma, WHO grade 4. Diagnosis has be made using the 2021 WHO Classification of Tumors of the CNS.\n3. The neurosurgeon must confirm (a) the tumor location (\\> 1 cm from eloquent brain), (b) that the placement of infusion catheter within or through the progressive enhancing tumor is feasible and is at a safe distance to eloquent brain function. These aspects will be determined prior catheter placement on the basis of prior (screening) MRI and then at the time of catheter placement on the basis of a CT scan prior to infusion. The tip of the catheter must be placed as follows:\n\n   1. Within the enhancing portion or in the vicinity of enhancement of target lesion (i.e., infiltrative disease)\n   2. ≥ 0.5 cm from ventricles\n   3. ≥ 1 cm deep into the brain\n   4. ≥ 0.5 cm from the corpus callosum\n4. If a histological or pathological confirmation of recurrence (\\\u003C 6 weeks) is not available, a pre-infusion biopsy will be required to confirm recurrence.\n5. Adequate pulmonary function, with a baseline pulse oximetry of at 90% on room air.\n6. The subject must have received standard radiation therapy plus temozolomide and be refractory to radiation therapy plus temozolomide prior to enrollment.\n7. Prior to administration of MVR-C5252, the presence of recurrent tumor must be confirmed by histopathological analysis. (Distinguishing between recurrent active tumor and radiation necrosis is important to avoid delivering MVR-C5252 when there is no active disease).\n\n   Should participants have further surgical resection at any time following their participation in the study, patients will be invited to make any biospecimens available for correlative research.\n8. Karnofsky Performance Status (KPS) ≥ 70%\n9. Labs:\n\n   1. platelets ≥ 100,000 unsupported at initial screening, but ≥ 125,000 supported prior to biopsy\u002Fcatheter insertion\n   2. hemoglobin ≥ 9 gm\u002FdL, ANC ≥ 1000\u002FµL\n   3. creatinine ≤ 1.5x upper limit of normal (ULN)\n   4. total bilirubin ≤ 1.5 x ULN, AST\u002FALT ≤ 2.5 x ULN (subjects with known or suspected Gilbert's syndrome are excluded if total bilirubin \\> 3.0 x ULN or direct bilirubin \\> 1.5 x ULN)\n   5. PT, aPTT ≤ 1.2 x ULN prior to biopsy (if patient is taking warfarin, INR should be obtained and be \\\u003C 2.0)\n10. Able to undergo MRI brain with and without contrast\n11. If the patient is a sexually active female of childbearing potential, whose partner is male, or if the patient is a sexually active male, whose partner is a female of child bearing 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 at the time of screening and within 48 hours of starting the MVR-C5252 infusion.\n12. Signed informed consent approved by the Institutional Review Board\n\nExclusion Criteria:\n\n1. 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\n2. Patients who are pregnant or breastfeeding\n3. Patients with contrast-enhancing tumor crossing the midline, multifocal tumor, infratentorial tumor, tumor in eloquent brain regions, extensive tumor dissemination (subependymal or leptomeningeal), or in unsafe brain regions per the opinion of the treating neurosurgeon\n4. Unstable systemic disease in the opinion of the treating physician.\n5. Active infection requiring systemic therapy or causing fever (temperature \\> 38.1˚C) or subjects with unexplained fever (temperature \\> 38.1˚C) within 7 days prior to the day of investigational product administration.\n6. Patients on \\>4 mg per day of dexamethasone within the 2 weeks prior to admission for MVR-C5252 infusion or systemic therapy with immunosuppressive agents within 28 days prior to admission for MVR-C5252 infusion\n7. Patients who have not completed standard of care treatment prior to participation in this trial\n8. 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 of recurrent tumor\n9. Treated with immunotherapeutic agents prior to MVR-C5252 treatment, within 4 weeks, alkylating agents within 4 weeks, nitrosoureas within 6 weeks, or non-alkylating chemotherapy within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy\n10. Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy\n11. Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period\n12. Prior treatment with any oncolytic virus, cell therapy or gene therapy.\n13. Prior antitumor treatment with intracranial implants, such as Carmustine\n14. 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 MVR-C5252 prescription, including glycerol.\n15. Systemic use (other than topical) of anti-HSV drugs (including, but not limited to, acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir, etc.)\n16. Patients with cardiac risks including congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry, or a history of myocarditis.","18 Years",{"count":54,"type":20},51,[23],"This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.",[26],"2026-04-10",{"date":60,"type":35},"2026-04-15",{"date":62,"type":35},"2024-06-11",{"date":64,"type":20},"2028-12-01",{"name":66,"class":42},"Duke University",2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":43},"100629920","phase-1-dual-targeting-car-nk-cells-for-recurrentprogressive-glioblastoma-and-high-grade-glioma-100629920","NCT07480941","Dual-Targeting CAR-NK Cells for Recurrent\u002FProgressive Glioblastoma and High-Grade Glioma","A Phase 1, First-in-Human, Biomarker-Guided, Dose-Escalation and Expansion Study of Locoregional Dual-Targeting CAR-NK Cells Directed Against IL13Rα2, EGFR\u002FEGFRvIII, and\u002For B7-H3 (CD276) in Adults With Recurrent or Progressive Glioblastoma or High-Grade Glioma","DUAL-CAR-NK-GB","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically confirmed glioblastoma (WHO grade 4) or diffuse high-grade glioma (WHO grade 3 or 4) that is recurrent or progressive after standard therapy.\n* Planned clinically indicated tumor resection or stereotactic biopsy (or availability of adequate archived tumor tissue) to support antigen testing and locoregional catheter placement.\n* Tumor demonstrates expression of at least two of the following antigens above protocol-defined thresholds: IL13Rα2, EGFR (wild-type) and\u002For EGFRvIII, B7-H3 (CD276).\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Adequate organ function (hematologic, renal, hepatic) as defined by protocol laboratory criteria.\n* Ability to undergo brain MRI with contrast (unless contraindicated and alternative imaging is permitted).\n* Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled bacterial, viral, or fungal infection).\n* Known HIV infection with uncontrolled viral load; active hepatitis B or hepatitis C with detectable viral load (unless permitted per protocol).\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Requirement for high-dose systemic corticosteroids (e.g., \\>4 mg\u002Fday dexamethasone equivalent) within 7 days prior to lymphodepletion\u002Finfusion (physiologic replacement permitted).\n* Prior gene-modified cellular therapy (e.g., prior CAR-T\u002FCAR-NK) within 6 months, or prior therapy targeting IL13Rα2, EGFR\u002FEGFRvIII, or B7-H3 where residual engineered cells could confound safety assessments.\n* Diffuse leptomeningeal disease as the only site of disease, or anatomy that precludes safe catheter placement (unless specifically allowed by protocol).\n* Uncontrolled seizures despite optimal medical therapy.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk with lymphodepletion or infusion procedures.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or could interfere with protocol adherence.","75 Years",{"count":78,"type":20},36,[23],"This is a draft, ClinicalTrials.gov-style example record for a first-in-human Phase 1 study evaluating locoregional administration of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in adults with recurrent or progressive glioblastoma (GBM) or other high-grade glioma (HGG). Participants will undergo tumor antigen profiling for IL13Rα2, EGFR\u002FEGFRvIII, and B7-H3 (CD276). Based on this assessment, each participant will receive the most suitable dual-target CAR construct to reduce antigen-escape risk.",[29,82,83,84,85],"High-grade Glioma","Malignant Glioma","Recurrent Glioblastoma","Recurrent High-grade Glioma",[87,88,89,90,91,92,93,94,95,96,97],"CAR-NK","dual targeting","IL13Rα2","EGFR","EGFRvIII","B7-H3","CD276","locoregional","intracavitary","Ommaya reservoir","biomarker-guided","2026-03-14",{"date":100,"type":35},"2026-03-18",{"date":102,"type":35},"2026-02-02",{"date":104,"type":20},"2028-03-17",{"name":106,"class":107},"Beijing Biotech","INDUSTRY",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100528502","recurrent-high-grade-glioma-treated-by-litt-100528502","NCT06161610","Recurrent High Grade Glioma Treated by LITT","Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy","REGALITT","Inclusion Criteria:\n\n1. Aged 18 years old or above;\n2. Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment;\n3. Meet any of the following:\n\n   1. Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;\n   2. At least one image other than T1 contrast indicates progression;\n   3. Pathology shows progression or recurrence;\n   4. Other progress determined by the Clinical Events Committee (CEC);\n4. All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;\n5. Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;\n6. The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients may benefit from other treatments or may not benefit from this trial;\n2. No more than three months since the patient underwent craniotomy;\n3. MRI contrast cannot be performed;\n4. Severe coagulation disorder;\n5. Women who are pregnant, lactating, or planning to become pregnant within 6 months;\n6. Participated in any other clinical trials of drugs or medical devices within 3 months;\n7. Combined diseases that may interfere with treatment or prognosis assessment;\n8. Refuse or unlikely to complete follow-up assessment;\n9. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.",{"count":117,"type":20},135,[119],"NA","This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients.\n\nThe main questions it aims to answer are:\n\n* The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments.\n* The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment.\n\nThe primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.",[26],[123,26],"laser interstitial thermal therapy","2024-11-26",{"date":126,"type":35},"2024-11-29",{"date":128,"type":35},"2023-09-19",{"date":130,"type":20},"2027-09-19",{"name":132,"class":42},"Beijing Tiantan Hospital",9,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":43},"100539597","phase-1-cd200ar-l-and-allogeneic-tumor-lysate-vaccine-immunotherapy-for-recurrent-hgg-and-newly-diagnosed-dmgdipg-in-children-and-young-adults-100539597","NCT06305910","CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG\u002FDIPG in Children and Young Adults","Phase I Trial: CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy With Adjuvant Reirradiation for Recurrent High-Grade Glioma and Newly Diagnosed Diffuse Midline Glioma\u002FDiffuse Intrinsic Pontine Glioma in Children and Young Adults","Inclusion Criteria:\n\n* Histologically confirmed newly diagnosed DIPG\u002FDMG with documented H3K27M alteration (based on IHC or DNA sequencing performed in a CLIA-certified laboratory) or recurrent HGG. Patients cannot enroll until they are a minimum of 14 days and preferably within 30 days from the last dose of radiation.\n* Diagnosis of recurrent HGG based on MRI findings. Recurrent HGG must have received standard of care radiation at diagnosis. Prior biopsy material will be required to confirm diagnosis of HGG; however, biopsy of the recurrent\u002Fprogressive lesion will not be required for study enrollment.\n* Maximal safe resection is preferred prior to clinical trial enrollment if indicated and feasible.\n* Clinically stable on a dose of corticosteroids not to exceed an equivalent of dexamethasone 0.1 mg\u002Fkg\u002Fday (maximum 4 mg) for at least 2 weeks prior to study enrollment.\n* Prior therapy wash-out is required\n* Minimum of 28 days since last dose of any targeted therapy (including bevacizumab), immunotherapy, investigational agents.\n* Minimum of 10 days since any anti-cancer intervention: cytoreductive surgery\u002Flaser ablation and a minimum of 28 days since any viral therapy\n* Voluntary written consent obtained by patient if ≥18 years of age or a parent or guardian if \\\u003C18 years of age before the performance of any study-related procedure not part of standard medical care\n* Able to comply with follow-up visit schedule (i.e., return to clinic for follow-up visits).\n* Willing to allow for collection of pre-treatment research related blood collection \\[1-5 mL red top tube and 2-10 mL green top tubes (or to a max of 2 ml\u002Fkg of body weight)\\] for immune characterization. If a patient does not subsequently enroll in the study, the samples will be destroyed according to institutional protocol.\n* Lansky play performance score ≥60 (\\\u003C16 years) or Karnofsky (≥16 years) performance score of ≥60\n* Sexually active persons of child-bearing potential or with partners of childbearing potential must agree to use a highly effective form of contraception during the 2-year treatment period. Urine pregnancy tests will be obtained at defined time points during protocol therapy.\n* Adequate bone marrow reserve: Absolute neutrophil (segmented and bands) count (ANC) ≥1.0 x 10E9\u002FL, platelets ≥75 x 10E9\u002FL; Hemoglobin ≥8 g\u002FdL\n* Hepatic: Bilirubin ≤1.3 mg\u002FdL and SGPT (ALT) ≤2.5 x upper limit of normal (ULN) for age\n* Renal: Normal serum creatinine for age or creatinine clearance \\>60 ml\u002Fmin\u002F1.73 mE2\n\nExclusion Criteria:\n\n* Known sensitivity to the GBM6-AD tumor lysate vaccine, CD200AR-L, or imiquimod.\n* Unable to complete a standard upfront course of radiotherapy due to disease progression or intolerance of therapy.\n* Radiographic evidence of diffuse leptomeningeal disease.\n* Prior history of malignancy within 5 years of enrollment.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Concurrent use of tumor treatment field devices (e.g., Optune) - permitted until the time of consent.\n* History of any laboratory findings consistent with any uncontrolled immune system abnormalities such as hyper-immunity (e.g., autoimmune diseases, thyroid dysfunction, lupus, scleroderma, etc.) and hypo-immunity \\[e.g., myelodysplastic disorders, marrow failures, human immunodeficiency virus\u002Facquired immunodeficiency syndrome (HIV\u002FAIDS), transplant immune-suppression, etc.\\]. Any known autoimmune disease must be clinically silent and without associated laboratory abnormalities for at least 1 year in the absence of any disease directed therapy or systemic steroids.\n* Any conditions that could potentially alter immune function (e.g., HIV\u002FAIDS, hepatitis B, untreated hepatitis C, multiple sclerosis, renal failure).\n* Receiving ongoing treatment with any immunosuppressive drug for any reason, excluding those patients requiring a low dose of corticosteroids equivalent to dexamethasone 0.1 mg\u002Fkg\u002Fday (maximum 4 mg) or less for treatment of tumor-related edema.\n* Not able to tolerate an MRI or radiation therapy even with reasonable accommodations or sedation.\n* Known pregnancy or anticipated conception during the 1-year study period","2 Years","25 Years",{"count":19,"type":20},[23],"This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.\n\nThe primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma\u002FDiffuse Intrinsic Pontine Glioma (DIPG\u002FDMG).",[147,26],"Diffuse Midline Glioma, H3 K27M-Mutant","2024-03-05",{"date":150,"type":35},"2024-03-12",{"date":152,"type":20},"2024-03-15",{"date":154,"type":20},"2027-01-15",{"name":156,"class":107},"OX2 Therapeutics"]