[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anaplastic-astrocytoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anaplastic-astrocytoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,53,78,107,139,160,181,206,232,255,281,323],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100541748","early-phase-1-lorlatinib-for-newly-diagnosed-high-grade-glioma-with-ros-or-alk-fusion-100541748",false,"NCT06333899","Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion","A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion","Inclusion Criteria:\n\n1. Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment on TarGeT-SCR.\n2. Diagnosis:\n\n   Patients with newly diagnosed high-grade glioma (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors harbor an ALK or ROS-1 fusion alteration are eligible. Patients must have had histologically verified high-grade glioma from diagnostic biopsy or resection. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4. All other HGGs must be Grade 3 or 4.\n3. Disease Status:\n\n   Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is intended to be given. MRI of spine must be performed if disseminated disease is suspected clinically by the treating physicians. Patients with primary spinal tumors are eligible only if the patient is to receive either chemotherapy or focal radiation therapy, i.e., no craniospinal RT is intended to be given. Patients with leptomeningeal disease only, with no definitive identifiable primary tumor, and documented ALK or ROS-1 fusion, must be discussed with the Study Chair on a case-by-case basis.\n4. Performance Level:\n\n   Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients 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. Prior Therapy:\n\n   * Patients must not have received any prior anti-cancer chemotherapy.\n   * Prior use of corticosteroids is allowed (see below Exclusion Criteria)\n6. Organ Function Requirements 6.1 Adequate Bone Marrow Function Defined as:\n\n   * Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FμL\n   * Platelet count ≥ 100,000\u002FμL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n   * Hemoglobin \\>8 g\u002FdL (may receive transfusions) 6.2 Adequate Renal Function Defined as:\n   * Serum creatinine within normal institutional limits OR Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 6.3 Adequate Liver Function Defined as:\n   * Total bilirubin ≤ 2 × institutional upper limit of normal\n   * AST(aspartate aminotransferase)\u002FALT(alanine transaminase) ≤ 2.5 × institutional upper limit of normal 6.4 Adequate Pulmonary Function Defined as: Pulse oximetry \\> 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest).\n\n6.5Adequate Cardiac Function Defined as: QTc ≤ 470 msec (by Bazett formula) 6.6 Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n\n6.7 Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n\n   Females of reproductive potential must use an effective non-hormonal method of contraception, since lorlatinib can render hormonal contraceptives ineffective, during study treatment and for at least 6 months after the final dose. Males with female partners of reproductive potential must use effective contraception during treatment with lorlatinib and for 3 months after the final dose.\n2. Concomitant Medications\n\n   * Investigational Agents\u002FDrugs: Patients who have previously received or are currently receiving another investigational drug are not eligible.\n   * Anti-cancer Agents: Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible\n3. Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection.\n4. Patients who have received prior solid organ transplantation are not eligible.\n5. Patients must not have malabsorption syndrome or other condition affecting oral absorption.\n6. Patients must not be receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to treatment with loraltinib. Moderate inducers of CYP3A4 should be avoided\n7. Avoid concomitant use of lorlatinib with certain CYP3A substrates, for which minimal concentration changes may lead to serious therapeutic failures. If concomitant use is unavoidable, increase the CYP3A substrate dosage in accordance with approved product labeling.\n8. P-glycoprotein (P-gp) substrates: Lorlatinib is considered a moderate P-gp inducer. Co-administration of lorlatinib with P-gp substrates including but not limited to digoxin should be avoided as the concentration of these drugs may be reduced by lorlatinib.\n9. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.\n10. Patients with a known personal history of acute or chronic severe psychiatric disorders or current history of suicidal ideation and history of suicide attempt.",true,"ALL","1 Year","21 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.",[28,29,30,31,32,33,34,35,36],"High Grade Glioma","Diffuse Intrinsic Pontine Glioma","Anaplastic Astrocytoma","Infant Type Hemispheric Glioma","Glioblastoma","Glioblastoma Multiforme","WHO Grade III Glioma","WHO Grade IV Glioma","Diffuse Midline Glioma, H3K27-altered",[38,39,28,29],"ALK fusion","ROS fusion","RECRUITING","2026-06-25",{"date":43,"type":44},"2026-06-29","ACTUAL",{"date":46,"type":44},"2025-08-03",{"date":48,"type":22},"2035-06-01",{"name":50,"class":51},"Nationwide Children's Hospital","OTHER",18,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100503755","targeted-pediatric-high-grade-glioma-therapy-100503755","NCT05839379","Targeted Pediatric High-Grade Glioma Therapy","Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n1. Age: Patients must be ≥12 months and ≤39 years of age at the time of enrollment onto this screening protocol.\n2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. Diagnosis must have histologic confirmation from biopsy or resection. The diagnosis of HGG must have been confirmed by pathology review at the local site. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.\n3. Disease Status: There are no disease status requirements for enrollment.\n\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Patients with metastatic\u002Fdisseminated or multifocal disease or gliomatosis cerebri are eligible.\n   * Patients with a primary spinal tumor are eligible.\n   * Patients with secondary, radiation related HGG are eligible.\n4. Prior Therapy for HGG: Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide concurrent with radiation is permissible. Prior administration of avastin\u002Fbevacizumab is allowed (individual treatment arms have different washout period requirements, check individual arm eligibility). No other prior anticancer therapy for HGG will be allowed.\n\n   * Participants screening for assignment to TarGeT-L may not have received radiation.\n\n   Timing from surgery to start of RT: For patients who have started RT, radiation must have started \\\u003C42 days from definitive surgery or biopsy, however it is strongly recommended patients start RT within 31 days from definitive surgery (if patient had two surgeries, radiation must have started within 31 days from second surgery).\n5. Tumor Sample Availability OR results from previous molecular profiling\u002Ftargeted sequencing\n\n   * If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood, saliva, or buccal swab) must be submitted for comprehensive molecular screening at the time of screening enrollment.\n   * If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review.\n6. Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT (if relevant)\n\n   * Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT (if completing RT).\n   * Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT (if completing RT).\n   * Participants screening for TarGeT-L (lorlatinib) are eligible to enroll on TarGeT-SCR anytime between diagnosis and 31 days post definitive surgery (to allow time for molecular review).\n\nHowever, it is important to note the following:\n\n* For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT.\n* For treatment protocols that only include maintenance\u002Fadjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT\n\n  #SCREENING OPTIONS\n* OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories\n* OPTION2: Molecular screening through a national comprehensive tumor profiling program\n* OPTION3: Clinically validated targeted sequencing or focused profiling\n\nExclusion Criteria:\n\n-Tumors that do not meet HGG and DIPG diagnoses specified above","12 Months","39 Years",{"count":63,"type":22},350,"OBSERVATIONAL","The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.",[28,29,30,32,33,67,68,34,35],"Diffuse Midline Glioma, H3 K27M-Mutant","Metastatic Brain Tumor","2026-06-08",{"date":71,"type":44},"2026-06-10",{"date":73,"type":44},"2024-08-02",{"date":75,"type":22},"2034-08-28",{"name":50,"class":51},21,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100422375","loupe-based-intraoperative-fluorescence-imaging-100422375","NCT04780009","Loupe-Based Intraoperative Fluorescence Imaging","Loupe-Based Intraoperative Fluorescence Imaging for the Guidance of Brain Tumor Surgery","Inclusion Criteria:\n\n* adults with brain malignant gliomas undergoing resection\n* at least 18 years of age\n* able to understand the consent\n\nExclusion Criteria:\n\n* pregnant women\n* under 18 years of age\n* patients undergoing emergency surgery\n* inability to give consent due to dysphagia or language barrier","18 Years","90 Years",{"count":88,"type":22},30,"Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections.\n\nThis study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.",[33,30],[92,93,94,95,96],"fluorescence","resection","5-ALA","fluorescein","optical","2026-06-01",{"date":99,"type":44},"2026-06-03",{"date":101,"type":44},"2017-11-17",{"date":103,"type":22},"2027-08",{"name":105,"class":51},"Guoqiang Yu",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":106},"100153487","phase-1-repeated-super-selective-intraarterial-cerebral-infusion-of-bevacizumab-avastin-for-treatment-of-relapsed-gbm-and-aa-100153487","NCT01269853","Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA","Phase I\u002FII Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed\u002FRefractory Glioblastoma Multiforme and Anaplastic Astrocytoma.","Inclusion Criteria:\n\n* 18 years of age or older.\n* Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).\n* Patients must have at least one confirmed and evaluable tumor site. A confirmed tumor site is one in which is biopsy-proven.\n* Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of 0-2).\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period.\n\nExclusion Criteria:\n\n* Previous treatment with greater than 2 cycles of Bevacizumab at 10mg\u002Fkg (2 IV Infusions).\n* Women who are pregnant or lactating.\n* Patients with significant inter-current medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.",{"count":115,"type":22},54,[117,118],"PHASE1","PHASE2","The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg\u002Fkg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I\u002FII clinical research trial is an extension of that trial in that the investigators seek to test the hypothesis that repeated dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab to improve progression free and overall survival. The investigators expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to the patients in the near future.",[33,30],[122,123,124,125,126,127,32,128,129,130],"GBM","AA","AO","Brain","Tumors","Malignant","Multiforme","Anaplastic","Astrocytoma","2026-05-28",{"date":97,"type":44},{"date":134,"type":4},"2010-10",{"date":136,"type":22},"2029-10",{"name":138,"class":51},"Northwell Health",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":159},"100504051","phase-2-study-of-ribociclib-and-everolimus-in-hgg-and-dipg-or-ribociclib-and-temozolomide-in-dhg-h3g34-mutant-100504051","NCT05843253","Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant","Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG\u002FDIPG Which Harbor Alterations of the Cell Cycle and\u002For PI3K\u002FmTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant","TarGeT-A study strata definitions Part1: Initial Feasibility Study for the combination of ribociclib PfOS formulation with everolimus: Enrollment on this cohort will be limited to patients aged \\\u003C21 years with primary intracranial localized HGG and DIPG\n\nPart 2\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata C-D)\n* Stratum B: Patients with DIPG\n* Stratum C: Patients with primary thalamic, spinal cord, and\u002For secondary\u002Fradiation-related HGG.\n* Stratum D: Patients with metastatic\u002Fdisseminated HGG, multifocal HGG, and\u002For gliomatosis cerebri who received CSI.\n\nStratum E\n\n* Stratum E: Patients with localized DHG, H3G34-mutant.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR. For the Part 1 Initial Feasibility Cohort (receiving ribociclib and everolimus) only: patients must be \\\u003C21 years of age at the time of enrollment on this protocol.\n\n   1.2) Diagnosis: patients with newly-diagnosed HGG, including DIPG are eligible. All patients must have histologic confirmation tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR:\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology, consistent with diffuse WHO grade 2-4 glioma\n   * All other HGGs must be WHO grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Patients without measurable disease are eligible.\n   * Patients with metastatic or multifocal disease or gliomatosis cerebri who received upfront CSI are eligible\n   * Patients with a primary spinal HGG are eligible\n   * Patients with secondary, radiation-related HGG are eligible.\n2. Inclusion criteria for assignment to TarGeT-A, for all strata:\n\n2.1) Presence of at least one relevant actionable somatic alteration, detailed here:\n\n* Pathogenic alterations presumed to cause activation of cell cycle:\n* Amplification of CDK4 or CDK6\n* Deletion of CDKN2A, CDKN2B, or CDKN2C\n* Amplification of CCND1 or CCND2\n* Pathogenic alterations presumed to cause activation of the PI3K\u002FmTOR pathway:\n* Deletion or mutation of PTEN\n* Mutation or amplification of PIK3CA\n* Mutation of PIK3R1\n* Deletion or mutation of TSC1 or TSC2\n* Patients with evidence of homozygous (biallelic) RB1 loss by sequencing are excluded from TarGeT-A\n* Patients whose tumors harbor other alterations suspected to activate the cell cycle and\u002For PI3K\u002FmTOR pathway could potentially also be eligible, but only following consensus recommendation by the international multidisciplinary molecular screening committee.\n* For Stratum E: H3G34 (R\u002FV) mutation\n\n2.2) Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of ag. Patients 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.\n\n2.3) Prior Therapy for HGG:\n\n* Surgery, RT, dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible. Avastin\u002Fbevacizumab use is permitted given the last dose was administered \\> 21 days prior to enrollment. No other prior anticancer therapy for HGG will be allowed.\n* Patients must have received photon or proton RT.\n* Patients must have started RT \\\u003C 42 calendar days from initial diagnosis defined as the date of diagnostic biopsy or resection. If a patient underwent 2 upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n* RT delivered via photon or proton beam, must have been administered at a standard dose including (54 Gy in 30 fractions for DIPG, 54-59.4 Gy in 30-33 fractions), 45 Gy-54 Gy for primary spinal disease, and\u002For 36 Gy-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54 Gy-60 Gy for intracranial metastasis. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.\n* Patients must enroll and start treatment No later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.\n\n2.4) Organ Function Requirements\n\n2.4.1) Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Hemoglobin \\>8 g\u002FdL (may be transfused)\n\n2.4.2) Adequate Renal Function Defined as:\n\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows: 1 to \\\u003C 2 years=0.6 mg\u002FdL for males and females; 2 to \\\u003C 6 years=0.8 mg\u002FdL for males and females; 6 to \\\u003C 10 years= 1.0 mg\u002FdL for males and females; 10 to \\\u003C 13 years=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.4.3) Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 times institutional upper limit of normal for age\n* AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional upper limit of normal\n* Serum albumin ≥ 2g\u002FdL\n\n2.4.4) Adequate Cardiac Function Defined as:\n\n* Ejection fraction of ≥ 50% by echocardiogram\n* QTc ≤ 450 msec (by Bazett formula)\n\n2.4.5) Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not strong inducers or inhibitors of CYP3A4\u002F5.\n\n2.4.6) Adequate Pulmonary Function Defined as: No evidence of dyspnea at rest, and a pulse oximetry \\>94% on room air if there is clinical indication for determination.\n\n2.5) Ability to take medications by mouth: For ribociclib and everolimus strata, patients must be able to take study medications by mouth as administration via NG\u002FNJ\u002FG tube is not allowed.\n\n2.6) Informed Consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\n2.7) Contraception: Male and female patients of childbearing potential must be willing to use a highly effective contraception method.\n\nExclusion Criteria\n\n1. Pregnant or Breast-Feeding Pregnant or breast-feeding women will not be entered on this study due to known potential risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use at least one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD)\n   * Intra Uterine hormone releasing system\n   * Bilateral tubal occlusion\n   * Vasectomized partner\n   * Sexual abstinence (avoiding having heterosexual intercourse) The following contraceptive measures are NOT considered effective\n   * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation\n   * Male or female condom with or without spermicide\n   * Cap, diaphragm or sponge with spermicide\n2. Concomitant Medications\n\n   * Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Patients who are currently receiving another investigational drug are not eligible.\n   * Patients who are currently receiving other anti-cancer agents are not eligible, with the exception of temozolomide given concurrently with RT only.\n   * Patients who are receiving enzyme inducing anticonvulsants that are strong inducers or inhibitors of CYP3A4\u002F5 are not eligible.\n   * Patients who are receiving strong inducers or inhibitors of CYP3A4\u002F5 are not eligible and should be avoided from 14 days prior to enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible.\n   * Patients who are receiving therapeutic anticoagulation with warfarin or other coumadin-derived anticoagulants are not eligible. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed as long as the patient has adequate coagulation defined as aPTT \\\u003C 1.5Xs ULN and INR \\\u003C 1.5.\n3. Patients who have an uncontrolled infection are not eligible.\n4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n5. Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n6. Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the subject, or could impair the assessment of study results are not eligible.",{"count":147,"type":22},120,[118],"The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K\u002FmTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant.\n\nThe main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG\u002FDIPG or DHG H3G34-mutant.",[28,29,30,32,33,67,68,34,35,151],"Diffuse Hemispheric Glioma, H3 G34-Mutant","2026-05-27",{"date":154,"type":44},"2026-05-29",{"date":156,"type":44},"2024-08-22",{"date":75,"type":22},{"name":50,"class":51},20,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":106},"100536404","phase-2-db107-retroviral-replicating-vector-rrv-combined-with-db107-flucytosine-fc-in-patients-with-recurrent-glioblastoma-or-anaplastic-astrocytoma-100536404","NCT06264388","DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma","A Biomarker-Guided Phase 2 Study of DB107-RRV (Retroviral Replicating Vector) Combined With DB107-Flucytosine Extended-Release Tablets in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma","Inclusion Criteria:\n\n1. Patients 18-75 years old.\n2. Histologically proven HGG that have recurred\u002Fprogressed (first or second recurrence).\n3. Patients with unresectable or resectable HGG (AA or GBM) will be enrolled.\n4. Measurable disease on MRI as evidenced by 1 cm on two separate dimensions on MRI fluid attenuated inversion recovery (FLAIR) (non-enhancing) or contrast-enhancement.\n5. Last temozolomide dosage 4 weeks prior to surgery.\n6. Patients with prior radiation therapy are allowed, but histological tumor diagnosis of recurrent tumor must be confirmed according to the RANO criteria. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI. If first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.\n7. Presence of Denovo Genomic Marker 7 (DGM7) biomarker in blood.\n8. Laboratory values (Platelet count ≥ 80,000, hemoglobin \\[Hg\\] ≥10 g\u002FdL, absolute neutrophil count (ANC) \\> 1,500 cells\u002Fmm3, absolute lymphocyte count (ALC) \\> 500\u002Fmm3) and adequate liver function, total bilirubin\\\u003C 1.5 upper limit of normal (ULN), alanine transaminase (ALT) \\\u003C2.5 ULN. Estimated glomerular filtration rate (eGFR) should be \\> 50 mL\u002Fmin (Cockcroft Gault Formula). Patients with aspartate transaminase (AST) or ALT values \\>3 ULN and total bilirubin \\>1.5 mg\u002FdL will be excluded.\n9. Patients cannot be pregnant at the time of enrollment or during the study. Patients willing to use one (1) effective method of contraception in addition to barrier methods (condoms) from the time of signing the informed consent form until 12 months after receiving the last dose of DB107-RRV or until there is no evidence of DB107-RRV in their blood, whichever is longer.\n10. Karnofsky Performance Score (KPS) ≥ 70.\n11. Patient is able to consent and abide by protocol.\n\nExclusion Criteria:\n\n1. History of active other malignancy (other than non-melanoma skin cancers, cervical ductal carcinoma in situ or localized prostate cancer) within 5 years.\n2. Multifocal gliomas that cannot undergo stereotactic biopsy\u002Fadministration of DB107-RRV will be excluded. Patients with 3 or more intracranial recurrences will be excluded.\n3. Histologically confirmed oligodendroglioma or mixed gliomas.\n4. History of human immunodeficiency virus (HIV) infection or other forms of severe immunosuppression.\n5. Patients with impaired renal function (eGFR\\\u003C50 cc\u002Fmin).\n6. Patients with bone marrow depression, such as those with a hematological disease or who are being treated with radiation or drugs that depress bone marrow or individuals who have a history of treatment with drugs or radiation that depress bone marrow within 1 month of enrollment.\n7. The patient intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer \\\u003C 30 days from surgery.\n8. Allergy to 5-FC.\n9. Gastrointestinal diseases that prevent absorption of medications such as 5-FC.\n10. Pregnancy or patients who are actively breast-feeding.\n11. Recent use of cytosine arabinoside (\\\u003C 3 weeks).\n12. Recent treatment with bevacizumamab (\\\u003C 3 weeks).\n13. Recent treatment with temozolomide (\\\u003C4 weeks).\n14. History of bleeding diathesis or current anti-coagulant or anti-platelet usage, including nonsteroidal anti-inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery.\n15. Sustained dependence on systemic dexamethasone (\\>8 mg\u002Fday) one month prior to surgery.\n16. Severe systemic illnesses including cardiopulmonary dysfunction (New York Heart Association \\> Grade 2 congestive heart failure (CHF), uncontrolled arrhythmias, significant pulmonary disease \\> Grade 2 dyspnea) or other serious medical condition or social situations that in the judgement of the Investigator(s) would interfere or limit compliance with study requirements\u002Ftreatments.\n17. The patient has or had any active infection requiring systemic antibiotic, antifungal or antiviral therapy within the past 4 weeks.\n18. Current or active coronavirus disease (COVID-19) disease, positive quantitative polymerase chain reaction (qPCR) result.\n19. Patients with impaired decision-making capacity.\n20. Patients who are currently receiving investigational medications or medical device(s) within 4 weeks (or 5 half-lives of the investigational medication(s), whichever is shorter) prior to enrollment.\n21. Patients who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the patient's compliance or place the patient at higher risk of potential treatment complications.","75 Years",{"count":169,"type":22},33,[118],"The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent\u002Fprogressive, resectable or unresectable disease and increase the time that disease is controlled.",[28,30],"2026-05-26",{"date":131,"type":44},{"date":176,"type":44},"2024-05-01",{"date":178,"type":22},"2034-05-01",{"name":180,"class":51},"Ashish Shah",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":106},"100492928","phase-1-a-study-of-temodar-with-abexinostat-pci-24781-for-patients-with-recurrent-glioma-100492928","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)","19 Years",{"count":190,"type":22},24,[117],"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.",[194,30,195,32,196],"Recurrent High Grade Glioma","Anaplastic Oligodendroglioma","Gliosarcoma","2026-04-13",{"date":199,"type":44},"2026-04-17",{"date":201,"type":44},"2023-06-26",{"date":203,"type":22},"2029-07",{"name":205,"class":51},"University of Nebraska",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":106},"100270475","phase-2-super-selective-intra-arterial-repeated-infusion-of-cetuximab-erbitux-with-reirradiation-for-treatment-of-relapsedrefractory-gbm-aa-and-aoa-100270475","NCT02800486","Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed\u002FRefractory GBM, AA, and AOA","Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed\u002FRefractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age\n* Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)\n* Patients with pathology confirmed histologic EGFR overexpression\n* Patients must have at least one confirmed and evaluable tumor site.∗\n\n  \\*A confirmed tumor site is one in which is biopsy-proven\n* Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.\n* No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol\n* Patients must have adequate hematologic reserve with WBC≥3000\u002Fmm3, absolute neutrophils ≥1500\u002Fmm3 and platelets ≥100,000\u002F mm3. Patients who are on Coumadin must have a platelet count of ≥150,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5X the institutional upper limit of normal (IUNL); AST or ALT\\\u003C2.5X IUNL and creatinine\\\u003C1.5X IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Women of childbearing potential and fertile men will be informed of the potential unknown risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period\n* Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring\n* Patients with radiological evidence of leptomeningeal disease\n* Patients with history of allergic reaction to CTX\n* Patients who completed chemo\u002FRT less than 6 months prior to enrollment\n* Patients who have not failed standard Stupp protocol",{"count":214,"type":22},37,[118],"Primary 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. GBM often has a high expression of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg\u002Fm2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.",[32,30,218,219,220,221,222,223,224],"Anaplastic Oligoastrocytoma","Glioma","Brain Neoplasm","Brain Cancer","Brain Tumor","Brain Tumor, Recurrent","Brain Neoplasm, Malignant","2026-04-08",{"date":197,"type":44},{"date":228,"type":44},"2016-05",{"date":230,"type":22},"2036-05",{"name":138,"class":51},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":106},"100332064","phase-1-hsv-tk-and-xrt-and-chemotherapy-for-newly-diagnosed-gbm-100332064","NCT03603405","HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM","Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination With Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.","Inclusion Criteria:\n\n* All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease defined as multiple lesions greater than 2 cm separate from the primary treatment target, or brainstem involvement as well as radiographic evidence consistent with these diagnoses.\n* Life expectancy ≥ 12 weeks.\n\n  \\- Patient can receive second treatment of HSV-tk after 6 months\n* Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor, but no radiation or chemotherapy has been received, ECOG performance status of 0-1. No evidence of other active malignancy (except squamous or basal cell skin cancers).\n* Patients with leptomeningeal disease may be considered for enrollment into the study.\n* Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his\u002Fher designee) with the aid of written information.\n* Willing to provide biopsies as required by the study.\n* WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating.\n* WOCBP and men must practice an effective method of birth control\n* Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol:\n* serum creatinine \\\u003C 1.5 mg\u002FdL\n* T. bilirubin \\\u003C 2.5 mg\u002FdL, ALT, AST, GGT and Alk Phos \\\u003C 2 x normal\n* Platelet count \\> 100,000\u002Fml , ANC\\> 1500\u002Fml , Hgb\\> 10 gm\u002FdL\n* Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)\n\nExclusion Criteria:\n\n* Prior treatment with immunomodulatory therapy, immunotherapy, and\u002For gene vector therapy in the past 3 months.\n* Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start.\n* Evidence of substantial multifocal disease defined as multiple lesions greater than 2cm separate from the primary treatment target, or brainstem involvement. Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI scan are not considered multifocal disease, as this represents a single tumor.\n* Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.\n* Patients on immunosuppressive drugs (other than steroids for brain edema).\n* In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.\n* In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled.\n* Liver disease, such as cirrhosis or active\u002Fchronic hepatitis B or C.\n* History of or current alcohol misuse\u002Fabuse within the past 12 months.\n* Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector\u002FValacyclovir).\n* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).\n* No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 3 years.\n* The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging\n* The presence of active untreated cellulitis or untreated wound infections. Treated and resolving cellulitis and infections are not an exclusion criteria.\n* Active IV drug abuse or severe opioid abuse\n* Pregnant or breastfeeding women or women\u002Fmen able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment.\n* Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.\n* Patients \\\u003C 18 years of age\n* Unwilling or unable to comply with the study protocol.",{"count":240,"type":22},62,[117,118],"Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).",[32,30],[245],"GBM, AA, Glioblastoma, Astrocytoma","2026-03-25",{"date":248,"type":44},"2026-03-30",{"date":250,"type":44},"2018-02-28",{"date":252,"type":22},"2026-12-31",{"name":254,"class":51},"The Methodist Hospital Research Institute",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":106},"100445745","phase-1-study-of-pembrolizumab-and-m032-nsc-733972-100445745","NCT05084430","Study of Pembrolizumab and M032 (NSC 733972)","A Phase I\u002FII Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent\u002FProgressive and Newly Diagnosed Glioblastoma Multiforme, Grade 3 or Grade 4 Astrocytoma, or Gliosarcoma","Inclusion Criteria:\n\nPhase I\u002FCohort I: Participants are eligible to be included in the study only if all of the following criteria apply:\n\nPatients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, and is deemed a potential candidate for resection of the recurrent tumor.\n\nPrior therapy: Patients must have failed external beam radio-therapy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy. All radiation and additional chemotherapies must have been completed at least 4 weeks prior to enrollment. Prior therapy with nitrosoureas must have been completed at least 6 weeks prior to enrollment.\n\nPhase I\u002FCohort II or Phase II: Participants are eligible to be included in the study only if all of the following criteria apply:\n\nPatient must have MRI findings consistent with probable malignant glioma, have no previous diagnosis of glioma, and have had either no history of any surgery for brain tumor. The exception to this requirement is that patients who have under-gone biopsy for diagnosis only and have not received any other treatment. All patients must be potential candidates for resection of the probably malignant glioma tumor.\n\nShould a patient in Phase I\u002FCohort II or Phase II be found on final pathologic diagnosis to not have a glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, he\u002Fshe will receive no other doses of M032 other than that administered at the time of craniotomy, nor will he\u002Fshe receive any doses of Pembrolizumab. He\u002Fshe will be followed for evidence of toxicity of M032 only and will be considered off-study for all efficacy and other secondary endpoints.\n\nAll patients, whether in Phase I\u002FCohort II or Phase II shall also be required to meet the following eligibility and be subject to the exclusion criteria below:\n\n1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of M032 in patients \\\u003C16 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.\n2. Karnofsky Performance Status (KPS) ≥70% (see Appendix B).\n3. Life expectancy of greater than 4 weeks.\n4. Preoperatively, the lesion must be ≥1.0 cm in diameter as determined by MRI.\n5. The effects of M032 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for six months after receiving the final dose of M032. Because it is currently unknown if M032 can be transmitted by sexual contact, a barrier method of birth control must be employed and for six (6) months following the administration of the last dose of this study drug. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. Subjects should also refrain from donating blood during the trial.\n6. Ability to understand and the willingness to sign a written informed con-sent document.\n7. Females of childbearing potential must not be pregnant; this will be con-firmed by a negative serum pregnancy test within 14 days prior to starting study treatment.\n8. Patients must have normal organ and marrow function as defined below:\n\n   1. leukocytes……………………. \\>3,000\u002Fμl\n   2. absolute neutrophil count………. \\>1,500\u002Fμl\n   3. platelets…………………………... \\>100,000\u002Fμl\n   4. total bilirubin……………………. within normal institutional limits\n   5. AST(SGOT)\u002FALT(SGPT)………… \\\u003C2.5 X institutional upper limit of normal creatinine within normal institutional limits Or\n   6. creatinine clearance……………... \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above insti-tutional normal\n\n      Exclusion Criteria:\n\n      A Woman of Child Bearing Potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to allocation.(see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n      Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).\n\n      Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.\n\n      Note: Participants must have recovered from all adverse events (AEs) due to previous thera-pies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.\n\n      Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n\n      Has received a live vaccine within 30 days prior to the first dose of study drug. 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\n      Is currently participating in or has participated in a study of an interventionally-directed investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n      Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent or if the agent is directed at analysis and not treatment (e.g., certain PET tracers, etc.).\n\n      Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 2 mg daily of dexamethasone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n\n      Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n      Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n\n      Has active autoimmune disease that has required 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 therapy for adrenal or pitu-tary insufficiency, etc.) is not considered a form of systemic treatment.\n\n      Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n\n      Has an active infection requiring systemic therapy.\n\n      Has a known history of Human Immunodeficiency Virus (HIV).\n\n      Has a known history of Hepatitis B (defined as Hepatitis B surface anti-gen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n\n      Has a known history of active Bacillus Tuberculosis (TB).\n\n      Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n\n      Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n      Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening vis-it through 120 days after the last dose of trial treatment.\n\n      Patients who have had chemotherapy, cytotoxic therapy, immunotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas), surgical resection within 4 weeks prior to entering the study, or have received experimental viral therapy or gene therapy at any time (e.g., adenovirus, retrovirus or herpes virus protocol). However, this does not preclude re-treatment with M032 at a later date.\n\n      Patients who have not recovered from adverse events due to therapeutic interventions administered more than 4 weeks earlier.\n\n      History of allergic reactions attributed to compounds of similar biologic composition to M032 or to IL-12.\n\n      Tumor involvement which would require ventricular, brainstem, basal ganglia, or posterior fossa inoculation or would require access through a ventricle in order to deliver treatment.\n\n      History of encephalitis within the past 5 years, any history of multiple sclerosis or other CNS infection. Bacterial infections associated with previous cranial operations such as bone flap infections, cerebral abscesses, etc., that have been completely treated will not be exclusions for this trial\n\n      For Phase I, Cohort I: Required steroid increase within 2 weeks of scheduled M032 administration. All study candidates: When possible, the patient should be on a dexamethasone equivalent dose of ≤ 2mg daily at the time of treatment.\n\n      Active herpes lesion.\n\n      Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).\n\n      Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery.\n\n      Patients with known history of allergic reaction to IV contrast material that is not amenable to pre-treatment by protocol.\n\n      Patients with pacemakers, ferro-magnetic aneurysm clips, metal infusion pumps, metal or shrapnel fragments or certain types of stents.\n\n      Receipt of Gliadel Therapy.\n\n      Receipt of Bevacizumab (Avastin) therapy within 4 weeks of scheduled M032 administration. (Receipt of Bevacizumab (Avastin) greater than 4 weeks of scheduled M032 administration does not exclude patient.",{"count":263,"type":22},28,[117,118],"This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of M032 (provided by the Phase I) when given in conjunction with Pembrolizumab for recurrent malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or glio-sarcoma).",[33,30,196],[268,269,270,271],"Recurrent","Progressive","M032","Pembrolizumab","2026-01-20",{"date":274,"type":44},"2026-01-22",{"date":276,"type":44},"2022-02-25",{"date":278,"type":22},"2028-03-01",{"name":280,"class":51},"University of Alabama at Birmingham",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":312,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":106},"100404034","phase-1-phase-i-study-of-oral-onc206-in-recurrent-and-rare-primary-central-nervous-system-neoplasms-100404034","NCT04541082","Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms","A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms","Inclusion Criteria:\n\nPatients must meet all the following criteria to participate in the study:\n\n1. Patients aged ≥18 years with a recurrent, primary CNS neoplasm. For all cohorts, patients must have a histologically confirmed primary CNS neoplasm. Primary CNS neoplasms in this study include, but are not limited to, the following: glioblastoma and glioblastoma histologic subtypes, gliosarcoma, primary CNS sarcomas, anaplastic glial neoplasms including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed neuronal-glial tumors, and pilocytic astrocytoma with anaplastic features, diffuse astrocytoma, oligodendroglioma, gliomatosis cerebri, pleomorphic xanthoastrocytoma, anaplastic pleomorphic xanthoastrocytoma, diffuse midline gliomas and histone mutated gliomas (NOTE: Patients with H3 K27M-mutant diffuse gliomas are excluded unless the primary tumor is located in the pons or spinal cord, or the patient has completed front line radiation or received ONC201 therapy prior to 01 January 2023), ependymoma, anaplastic ependymoma, and all ependymoma subtypes, medulloblastoma and all medulloblastoma subtypes, atypical teratoid\u002Frhabdoid tumor, primary CNS embryonal\u002Fprimitive neuroectodermal tumors, atypical and anaplastic meningiomas, choroid plexus tumors, and pineal region tumors.\n2. Patients must have recurrent and measurable disease as defined by RANO criteria, using either the HGG and\u002For LGG RANO criteria based on tumor type, after having received established standard of care treatment for their disease and have no standard treatment options available as determined by the investigators. There is no limit on the number of total recurrences or prior therapies. However, prior therapies with known clinical benefit (including radiation) for specific tumor types are required. If patients are deemed ineligible for such therapies in the opinion of the Investigator, the Investigator must document the reason the patient is considered ineligible.\n3. Patients must have a Karnofsky Performance Score (KPS) of greater than or equal to 70. Patients with severe paraparesis\u002Fparaplegia who need minimal assistance for self-care due to their motor deficit but are otherwise functionally independent will be considered eligible.\n4. (Inclusion Criterion #4 was removed in Amendment 3.)\n5. Patients must not have received prior investigational or approved cytotoxic chemotherapy within 28 days prior to the first dose of study drug (Cycle 1, Day 1); 42 days in the case of nitrosoureas; 42 days in the case of bevacizumab; 28 days or 5 half-lives (whichever is less; but not less than 14 days) in case of investigational or approved molecularly targeted agent; 14 days in the case of radiotherapy.\n6. (Inclusion Criterion #6 was removed in Amendment 7.)\n7. Patients with AEs Grade ≥2 related to prior therapies (chemotherapy, radiotherapy, and\u002For surgery) must have all their AEs resolved prior to the first dose of study drug (Cycle 1, Day 1), except for alopecia or neuropathy; Grade 1 or 2 lymphopenia is allowed.\n8. Patients must not have undergone major surgery 4 weeks prior to the first dose of study drug (Cycle 1, Day 1) and must have completely recovered from any surgery (minor surgical procedures such as skin biopsies and port placement done on an outpatient basis do not require a waiting period).\n9. Patients must have normal organ and marrow function as defined below:\n\n   * Absolute neutrophil count (ANC) ≥1,500\u002FmcL.\n   * Platelets ≥100,000\u002FmcL.\n   * Hemoglobin ≥9.0 mg\u002FdL without transfusion in 2 prior weeks.\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert's syndrome may be included with total bilirubin \\>1.5 × ULN if direct bilirubin is ≤1.5 × ULN).\n   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × ULN.\n   * Measured or estimated creatinine clearance (CLcr) ≥40 mL\u002Fminute for patients with creatinine levels above normal. CLcr will be calculated by the Cockcroft-Gault equation for renal function.\n10. (Inclusion Criterion #10 was removed in Amendment 3)\n11. Patients must provide a tumor specimen (paraffin-embedded block and\u002For frozen tissue) from a prior resection or biopsy available that is sufficient to perform biomarker assays, ≥15 unstained slides for immunohistochemistry (IHC) analysis must be received by the NOB by the first dose of study drug (Cycle 1, Day 1). For patients with ≥10 to \\\u003C15 slides, eligibility will be reviewed on a case-by-case basis.\n12. Dependent upon dose level assignment and drug formulation (i.e., capsules versus powder in bottle \\[PIB\\]), patients must be able to either swallow oral capsules or swallow liquids.\n13. Patients must provide study-specific informed consent prior to enrollment. No Durable Power of Attorney or Next of Kin can provide initial consent.\n14. Patients must be able to tolerate a magnetic resonance imaging (MRI) study with intravenous gadolinium contrast.\n15. (Inclusion Criterion #15 was removed in Amendment 6)\n16. Patients must have a negative COVID-19 test within 72 hours of the first dose of study drug (Cycle 1, Day 1). Patients who had documented COVID-19 infection within 90 days of treatment but more than 20 days from infection do not need to be tested.\n17. (Inclusion Criterion #17 was removed in Amendment 6)\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. (Exclusion Criterion #1 was removed in Amendment 3)\n2. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC206 (e.g., ONC201) or its excipients.\n3. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n4. Patients who are unable or unwilling to abide by the study protocol or cooperate fully with the Investigator.\n5. Patients with a known HIV-positive test on combination anti-retroviral therapy are ineligible for this initial first-in-human trial because of the potential for PK interactions with ONC206.\n6. Patients with active cardiac disease, including any of the following:\n\n   * Corrected QT interval (QTc) ≥470 msec on screening electrocardiogram (ECG; using the QTc by Fridericia's \\[QTcF\\] formula);\n   * Angina pectoris that requires the use of anti-anginal medication;\n   * Ventricular arrhythmias except for benign premature ventricular contractions;\n   * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\n   * Conduction abnormality requiring a pacemaker;\n   * Valvular disease with documented compromise in cardiac function; and\u002For\n   * Symptomatic pericarditis.\n7. Patients with a history of cardiac dysfunction including any of the following:\n\n   * Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction function;\n   * History of documented congestive heart failure (New York Heart Association functional classification III-IV); and\u002For\n   * Documented cardiomyopathy.\n8. Patients who have had an ischemic or hemorrhagic stroke in the last 3 months. If the patient has had a recent tumor resection, cerebral ischemic or hemorrhagic changes that occur peri operatively are not an exclusion.\n9. Patients with refractory epilepsy are excluded. Patients with primarily or secondarily generalized seizures in the 28 days prior to study enrollment will be excluded. Peri-operative seizures, defined as seizures occurring within the 7 days after a stereotactic biopsy, open biopsy, or surgical resection will not be an exclusion as long as the patient has had no generalized seizures starting 8 days after the surgical procedure. Patients with prior seizures must be on stable doses of 1 or 2 seizure medications for at least 14 days prior to study enrollment.\n10. Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ONC206 (uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n11. Patients who have been treated with any hematopoietic colony-stimulating growth factors (CSFs) (e.g., granulocyte-CSF, granulocyte-macrophage-CSF) ≤2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued.\n12. Patients who are currently taking therapeutic doses of warfarin sodium or any other coumadin derivative anticoagulant.\n13. Patients who are taking strong inhibitors or inducers of cytochrome P450 (CYP) 3A4, 2D6, 1A2, 2C9, and 2C19 within at least 14 days prior to the first dose of study drug (Cycle 1, Day 1); these medications are excluded throughout the study.\n14. Women who are pregnant or breast feeding.\n15. Women of child-bearing potential with a positive serum pregnancy test ≤72 hours prior to the first dose of study drug (Cycle 1, Day 1).\n16. Patients who are receiving concomitant standard and\u002For investigational anti-cancer therapy.\n17. Patients with alcohol or substance abuse which, in the opinion of the Investigator, would interfere with compliance or safety.\n18. Patients with the presence of any other serious and\u002For unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with patients' safety, obtaining informed consent or compliance to the study procedures as determined by the Investigators.\n19. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, or men who do not agree to use highly effective contraception during treatment and for 16 additional weeks after the final dose of study drug.\n\n    Highly effective contraception is defined as either:\n    * True abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Sterilization: Females must have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n    * Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * If patients are not practicing true abstinence and\u002For if the patient or sexual partner have not had a sterilization procedure as listed above, patients and their sexual partners must follow double barrier contraception in accordance with the guidelines for contraception below:\n\n      * Females of childbearing potential:\n\n        * Must use an intrauterine device or intrauterine system, during dosing of any study agent and for 16 weeks after final dose of study drug; or\n        * Must use a double barrier method of contraception: use of an occlusive cap (diaphragm or cervical\u002Fvault cap) with spermicide for women combined with use of a condom by their male partners capable of conceiving offspring.\n      * Males capable of conceiving offspring must use condoms during dosing of study agent and for an additional 16 weeks after final dose of study drug.\n\n    Note: Oral, implantable, or injectable contraceptives may be affected by CYP interactions, and are therefore not considered effective for this study.\n20. Previous receipt of ONC201, placebo, or blinded study drug from an ONC201 clinical study, or from any other source for H3 K27M-mutant diffuse glioma on or after 01 January 2023.",{"count":289,"type":22},102,[117],"The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.",[293,32,294,195,30,295,296,297,298,299,67,300,301,302,303,304,305,306,307,308,309,310,311],"Central Nervous System Neoplasms","Gliosarcoma, Adult","Pilocytic Astrocytoma","Oligodendroglioma","Gliomatosis Cerebri","Pleomorphic Xanthoastrocytoma","Anaplastic Pleomorphic Xanthoastrocytoma","Ependymoma","Ependymoma, Anaplastic","Medulloblastoma","Teratoid Rhabdoid Tumor","Neuroectodermal Tumors, Primitive","Neuroectodermal Tumors","Anaplastic Meningioma","Atypical Meningioma","Choroid Plexus Neoplasms","Pineal Tumor","Diffuse Astrocytoma","Glial Tumor",[32,30,195,310,296],"2025-12-17",{"date":315,"type":44},"2025-12-18",{"date":317,"type":44},"2020-10-26",{"date":319,"type":22},"2026-12",{"name":321,"class":322},"Jazz Pharmaceuticals","INDUSTRY",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":106},"100512774","phase-1-treatment-of-relapsedrefractory-intracranial-glioma-in-patients-under-22-years-of-age-100512774","NCT05956821","Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Phase I\u002FII Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Inclusion Criteria:\n\n* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)\n* Must have at least one confirmed and evaluable tumor site\n* Must have a Karnofsky or Lansky performance status ≥60%.\n* No chemotherapy for three weeks prior to treatment\n* Patients must have adequate hematologic reserve with absolute neutrophils≥1000\u002Fmm3 and platelets ≥100,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\\\u003C2.5x IUNL and creatinine\\\u003C1.5x IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL\n* Growth factor(s): Must not have received within 1 week of entry onto this study\n* Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.\n* Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients or their parents\u002Fguardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n* Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating\n* Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study\n* Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring",{"count":159,"type":22},[117,118],"This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \\\u003C 22 years of age.",[33,30,334,296,335,29,336,337],"Fibrillary Astrocytomas","Diffuse Intrinsic Brainstem Glioma","DIPG Brain Tumor","H3 K27M","2025-12-04",{"date":340,"type":44},"2025-12-08",{"date":342,"type":44},"2025-06-19",{"date":344,"type":22},"2029-12-01",{"name":346,"class":51},"University of Miami"]