[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-astrocytoma-idh-mutant-grade-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-astrocytoma-idh-mutant-grade-4":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,70,90,119],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100582229","phase-1-testing-the-addition-of-an-anti-cancer-drug-triapine-to-the-usual-radiation-therapy-for-recurrent-glioblastoma-or-astrocytoma-100582229",false,"NCT06860594","Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma","A Phase I Trial Combining Triapine With Radiation Therapy for Recurrent Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:\n\n  * GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)\n  * Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)\n  * Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.\n* Tumors ≤ 6 cm in maximal diameter.\n\n  * Patients who had recent resection for recurrent tumor must have measurable disease.\n* Patients must have at least a 6-month break from last dose of radiation therapy.\n\nRe-irradiation within 6 months may increase risk for radiation necrosis\u002Fedema, which will affect toxicity assessment and patient safety. Additionally, GBM and other high-grade astrocytic tumors can exhibit pseudo-progression within 6 months from completing definitive, 1st line radiation therapy, and re-irradiation during this period will increase risk for misattribution of effect.\n\n* Prior history of standard dose radiation for gliomas of 59.4-60 gray (Gy) in 1.8-2 Gy per fraction (or equivalent or lower) is allowed.\n* Patients who received non-standard radiation dose regimen (e.g., 40 Gy, 34-35 Gy, 25 Gy) or stereotactic radiosurgery are eligible as long as there is at least one of the following:\n\n  * A new tumor outside the original radiotherapy field as determined by the investigator.\n  * There is histologic confirmation of tumor on biopsy or resection.\n  * Imaging findings are consistent with true progressive disease (on standard MRI sequences, MRI spectroscopy\u002Fperfusion, or nuclear medicine imaging).\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of triapine in patients \\\u003C 18 years of age, children are excluded from this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).\n* Absolute neutrophil count ≥ 1,500\u002FmcL.\n* Hemoglobin ≥ 8 g\u002FdL.\n* Platelets ≥ 100,000\u002FmcL.\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN.\n* Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.\n* Patients must be able to swallow whole capsules.\n* Patients must be able to undergo MRIs with contrast. Patients with non-compatible devices with MRI can be eligible if CT scans of sufficient quality are obtained. However, patients without non-compatible devices may not use CT scans to meet this requirement.\n* The effects of triapine on the developing human fetus are unknown. For this reason and because ribonucleotide reductase (RNR) inhibitor agent and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after finishing study treatment. People of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 2 weeks of registration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of triapine administration.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents.\n* Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials \\[primaquine, chloroquine\\], cyclophosphamide, and ifosfamide).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.\n* Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.\n* Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.\n* Pregnant women are excluded from this study because triapine is a RNR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine. These potential risks may also apply to the radiation used in this study.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and\u002For effective in treating patients with recurrent glioblastoma or astrocytoma.",[26,27,28,29,30,31,32],"Astrocytoma, IDH-Mutant, Grade 2","Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant","Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant","Recurrent Astrocytoma, IDH-Mutant","Recurrent Astrocytoma, IDH-Mutant, Grade 3","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","RECRUITING","2026-06-27",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2025-07-30",{"date":41,"type":20},"2027-06-30",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",43,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100578725","phase-1-intracranial-genetically-modified-immune-cells-tgfr2koil13r2-car-t-cells-for-the-treatment-of-recurrent-or-progressive-glioblastoma-or-grade-3-or-4-idh-mutant-astrocytoma-100578725","NCT06815029","Intracranial Genetically Modified Immune Cells (TGFβR2KO\u002FIL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma","A Phase 1 Trial to Evaluate the Safety of IL13Rα2-Targeting Chimeric Antigen Receptor (CAR) T Cells With CRISPR Knockout of TGFβR2 in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with surgery\u002FRickham placement and CAR T cell infusion only after the translated main consent form is signed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 70%, Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy ≥ 4 weeks\n* If the participant has a shunt, they must be informed of the following:\n\n  * If the shunt is not programmable, the participant must be willing to have a programmable shunt placed prior to CAR T cell infusion, and\n  * If the shunt is programmable, in order to proceed to the treatment portion of the study, the participant must be able to tolerate their shunt being functionally closed for at least 2 hours\n* Participant has a prior histologically-confirmed diagnosis of a grade 3 or 4 IDH-mutant astrocytoma or glioblastoma, or has a prior histologically-confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 3 or 4 IDH-mutant astrocytoma\n* Relapsed disease: radiographic evidence of recurrence\u002Fprogression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy\n* COH clinical pathology confirms IL13Rα2+ tumor expression by immunohistochemistry (H-score ≥ 80)\n* No known contraindications to leukapheresis, steroids, or tocilizumab\n* White blood cell (WBC) \\> 2000 \u002Fdl (or absolute neutrophil count \\[ANC\\] ≥ 1,000\u002Fmm\\^3) (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Platelets ≥ 75,000\u002Fmm\\^3 (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Hemoglobin ≥ 8g\u002Fdl (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Serum creatinine ≤ 1.6 mg\u002FdL (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Oxygen (O2) saturation ≥ 95% on room air (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded\n* Participant has not yet recovered from toxicities of prior therapy\n* Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring intravenous (IV) antibiotics (e.g., minor scalp infection is not an exclusion)\n* Known history of human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Other active malignancy. Note: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":54,"type":20},27,[23],"This phase I trial tests the safety, side effects and best dose of TGFβR2KO\u002FIL13Rα2 chimeric antigen receptor (CAR) T-cells given within the skull (intracranial) in treating patients with glioblastoma or IDH-mutant grade 3 or 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. When the cells are taken from the patient's own blood, it is known as autologous. Then the gene for special receptors that bind to a certain proteins on the patient's tumor cells are added to the T cells in the laboratory. The special receptors are called CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving TGFβR2KO\u002FIL13Rα2 CAR T cells may be safe, tolerable, and\u002For effective in treating patients with recurrent or progressive glioblastoma or grade 3 or 4 IDH-mutant astrocytoma.",[30,31,58],"Recurrent Glioblastoma","2026-06-25",{"date":61,"type":37},"2026-06-29",{"date":63,"type":37},"2025-06-17",{"date":65,"type":20},"2030-10-11",{"name":67,"class":68},"City of Hope Medical Center","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":69},"100634846","phase-1-locoregional-administration-of-genetically-engineered-cells-egfril13r2-pool-car-t-cells-for-the-treatment-of-recurrent-or-progressive-high-grade-gliomas-100634846","NCT07544992","Locoregional Administration of Genetically Engineered Cells (EGFR\u002FIL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas","A Phase 1 Trial to Evaluate the Safety of EGFR\u002FIL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","Main Inclusion Criteria\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.\n* Age 18 years and older.\n* KPS ≥ 70%, ECOG ≤ 2 (Appendix A).\n* Life expectancy ≥ 4 weeks.\n* Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma.\n* Relapsed disease: radiographic evidence of recurrence\u002Fprogression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy.\n* COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):\n\n  * IL13Rα2+ expression by IHC \\> 20, and\n  * EGFR gene-altered by NGS or FISH analysis\n* No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.\n* WBC \\> 2000 \u002Fdl (or ANC ≥ 1,000\u002Fmm3)\n* Platelets ≥ 75,000\u002Fmm3\n* Hemoglobin \\> 9g\u002FdL\n* Total bilirubin ≤ 1.5x ULN\n* AST ≤ 2.5x ULN\n* ALT ≤ 2.5x ULN\n* Serum creatinine ≤1.6 mg\u002FdL\n* O2 saturation ≥ 95% on room air.\n* Seronegative for HIV Ag\u002FAb combo, HCV, and active HBV\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells.\n\nMain Exclusion Criteria\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.\n* Participant has not yet recovered from toxicities of prior therapy.\n* Participant has received any live vaccine within 30 days prior to enrollment.\n* Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Clinically significant uncontrolled illness.\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.\n* Other active malignancy.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":78,"type":20},24,[23],"This phase I trial studies the side effects and best dose of EGFR\u002FIL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR\u002FIL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.",[31,32],"2026-06-10",{"date":84,"type":37},"2026-06-12",{"date":86,"type":20},"2026-12-24",{"date":88,"type":20},"2031-11-04",{"name":67,"class":68},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":69},"100616104","phase-2-gi-102-alone-or-with-pembrolizumab-before-surgery-for-treatment-of-recurrent-or-progressive-idh-wildtype-glioblastoma-and-idh-mutated-grade-4-astrocytoma-100616104","NCT07301268","GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma","MC230719 Window Of Opportunity Study Of GI-102 In Patients With Recurrent High-Grade Glioblastoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma\n  * Candidates for surgical resection\n* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0\n* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml\u002Fmin (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained ≤ 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)\n* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)\n* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willingness to provide blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples collected on this protocol\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) \\\u003C 30 days prior to registration\n\n    * NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Increasing dexamethasone dose prior to registration\n\n    * NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg\u002Fday at time of registration\n  * Received chemotherapy \\\u003C 30 days prior to registration\n  * Received a live vaccine \\\u003C 30 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery \\\u003C 28 days prior to registration\n  * Radiation therapy \\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring IV antibiotics\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent at the time of registration\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n\n  * NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":98,"type":20},36,[100],"PHASE2","This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.",[103,104,105,106,31,32,107,108,109],"Glioblastoma, IDH-Wildtype","Progressive Astrocytoma, IDH-Mutant, Grade 4","Progressive Glioblastoma","Progressive Gliosarcoma","Recurrent Gliosarcoma","Resectable Astrocytoma","Resectable Glioblastoma","2026-04-02",{"date":112,"type":37},"2026-04-08",{"date":114,"type":37},"2026-04-01",{"date":116,"type":20},"2034-04-30",{"name":118,"class":68},"Mayo Clinic",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":69},"100499910","phase-1-allogenic-adipose-derived-mesenchymal-stem-cells-for-the-treatment-of-recurrent-glioblastoma-or-recurrent-astrocytoma-in-patients-undergoing-craniotomy-100499910","NCT05789394","Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy","Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma","Inclusion Criteria:\n\n* Participants \\>= 18 years\n* Karnofsky Performance Scale (KPS) \\>= 60\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system , who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor\n* There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria\n* Serum creatinine and urea \\\u003C= 2 times the upper limit of normal (=\\\u003C 3 weeks prior to registration)\n* Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =\\\u003C 3 times the upper limit of normal, and bilirubin =\\\u003C 2.5 mg\u002FdL (=\\\u003C 3 weeks prior to registration)\n* Prothrombin time =\\\u003C 1.5 times upper limit of normal (=\\\u003C 3 weeks prior to registration)\n* International normalized ratio (INR) and partial thromboplastin time (PTT) =\\\u003C 1.5 times the upper limit of normal (=\\\u003C 3 weeks prior to registration)\n* Hemoglobin \\>= 9 g\u002FdL (=\\\u003C 3 weeks prior to registration)\n* Platelets \\>= 100 x 10\\^9\u002FL (=\\\u003C 3 weeks prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (=\\\u003C 3 weeks prior to registration)\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Patient or legally authorized representative (LAR) is able to fully understand and provide written and verbal consent for the protocol\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to undergo Ommaya reservoir placement and provide cerebrospinal fluid (CSF) samples for correlative research\n\nExclusion Criteria:\n\n* Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention\n* Tumors located solely in the brain stem, midbrain, or thalamus without inclusion\u002Finvolvement of surrounding brain matter\n* Previous treatment with bevacizumab\n* Radiographic evidence of leptomeningeal disease",{"count":127,"type":20},20,[23],"This phase I trial tests the safety, side effects, and best dose of allogenic adipose-derived mesenchymal stem cells (AMSCs) in treating patients with glioblastoma or astrocytoma that has come back (recurrent) who are undergoing brain surgery (craniotomy). Glioblastoma is the most common and most aggressive form of primary and malignant tumor of the brain. Currently, the standard of care for this disease includes surgical resection, followed by radiation with chemotherapy and tumor treating fields. Despite this aggressive therapy, the survival after finishing treatment remains low and the disease often reoccurs. Unfortunately, the available therapy options for recurrent glioblastoma are minimal and do not have a great effect on survival. AMSCs are found in body fat and when separated from the fat, are delivered into the surgical cavity at the time of surgery. When in direct contact with tumor cells, AMSCs affect tumor growth, residual tumor cell death, and chemotherapy resistance. The use of AMSCs delivered locally into the surgical cavity of recurrent glioblastoma during a craniotomy could improve the long-term outcomes of these patients by decreasing the progression rate and invasiveness of malignant cells.",[32,31,131],"Astrocytoma, Grade IV","2026-03-31",{"date":110,"type":37},{"date":135,"type":37},"2023-06-16",{"date":137,"type":20},"2027-07-24",{"name":118,"class":68}]