[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-supratentorial-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-supratentorial-glioblastoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100438637","phase-1-phase-i-cb-nk-tgf-r2-nr3c1--in-rgbm-100438637",false,"NCT04991870","Phase I CB-NK-TGF-ßR2-\u002FNR3C1- in rGBM","A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)","Inclusion Criteria\n\n1. Signed and dated informed consent.\n2. Male or female participants aged ≥ 12 years on the day of signing informed consent.\n3. Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent gliosarcoma with any prior number of recurrences, and who have received prior radiation and temozolomide therapy. Participants will be eligible if the original histology was lower-grade glioma grade 2 or 3 and a subsequent histological diagnosis of recurrent glioblastoma or IDH-mutant grade 4 astrocytoma is made.\n4. Karnofsky Performance Score (KPS) of \\>70 at trial entry. Lansky \\>70 at trial entry for patients less than 16.\n5. Must be at least 12 weeks from receiving conformal radiation, unless RANO criteria for early progression are met.\n6. A baseline brain MRI with Advance Brain Tumor Imaging (ABTI) must be obtained no more than 30 days prior to study registration\n7. Patients having undergone recent surgery are eligible so long as they are at least 3 weeks from resection or at least 1 week from stereotactic biopsy and recovered from any operative or perioperative complications.\n8. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10°9\u002FL with absolute neutrophil count (ANC) ≥ 1.5 x 10°9\u002FL, lymphocyte count ≥ 0.5 x 10°9\u002FL, platelet count ≥ 100 x 10°\u002FL, and Hgb ≥ 9 g\u002F dL (in absence of blood transfusion).\n9. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 x ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5 10. Adequate renal function defined creatinine ≥ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\n11\\. Female participant of childbearing potential should have a negative serum pregnancy test within 14 days (+\u002F-2 working days) of study registration.\n\n12\\. Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study and for 3 months after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n\n13\\. Male participants should agree to use 2 methods of highly effective contraception starting with the first dose of study therapy and for 3 months after the last dose of study therapy.\n\n14\\. For the surgical expansion group (Group 2): there must be at least 1 cm2 of contrast-enhancing disease that is considered resectable by the neurosurgeon.\n\nExclusion Criteria\n\n1. Has received prior therapy with Gliadel or bevacizumab.\n2. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.\n3. Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4 weeks since last dose of agent administration or device use, or is planning to continue or start treatment with Optune® during participation in this trial.\n4. Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.\n5. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1\u002F2 antibodies); HTLV1 and\u002For HTLV2; active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with prior HBV vaccination (anti-HBs positive, HbsAg negative, anti-HBc negative) will NOT be excluded.\n6. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy within 7 days prior to study registration.\n7. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0.\n\n   1. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n   2. Note: If participant received major surgery (other than craniotomy), they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n8. Has had prior radiation therapy less than 12 weeks prior to study registration, unless RANO criteria for early progression are met.\n9. Has had prior therapy with any antibody\u002Fdrug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody within the last three months prior to study registration -.\n10. Has a known additional malignancy that is progressing or requires active treatment.\n\n    Exceptions include but are not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI.\n11. Has known gliomatous cerebri, extracranial disease, or tumor localized primarily to the brainstem or spinal cord.\n12. Brain midline shift greater than 0.5 cm or pending herniation seen on baseline MRI ABTI.\n13. Tumors larger than 5 cm at greatest diameter\n14. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n15. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n16. Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the participant's participation, assessment of experimental treatment toxicity or increase the participant's risk of side effects.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment.\n20. Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n21. Has a contraindication for undergoing MRIs.\n22. Has evidence of bleeding diathesis or coagulopathy.\n23. Is on full dose anticoagulants or antiplatelet therapy that cannot be held.\n24. Has significant hemorrhage on baseline MRI ABTI defined as \\>1 cm diameter of acute blood.\n25. Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n26. Has multicentric disease. Subject has multicentric GBM, defined as discrete sites of contrast enhancing disease without contiguous T2\u002FFLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2\u002FFLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.\n\nTreatment will be up to 32 weeks in duration.\n\nThe number of cells administered will be based on gene editing efficiency. CB-NK-TGF-£\\]R2-\u002FNR3C1-cells will be administered via intraventricular injection via an Ommaya reservoir on day 0 and every 4 weeks y for up to 8 doses total in Group 1.\n\nSurgical patients in Group 2 will undergo intraventricular insertion of an Ommaya (day -14 to -\n\n1). They will then undergo IT injection via the Ommaya reservoir of CB-NK-TGF-£\\]R2-\u002FNR3C1-cells on day 0. Prior to planned tumor resection to occur between days 7-14. Every 4 week intraventricular injections of CB-NK-TGF-£\\]R2-\u002FNR3C1- cells will be administered for a total of 8 intraventricular treatments.\n\nIn the setting of any surgical complications following Ommaya placement, CB-NK-TGF-£\\]R2-\u002FNR3C1- cells may be delayed and administered once the patient is deemed stable by the neurosurgeon following Ommaya placement.\n\nTreatment will continue until tumor progression or intolerable toxicity, or a maximum of 8 intraventricular treatments with CB-NK-TGF-£\\]R2-\u002FNR3C1- cells whichever occurs first.","ALL","12 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial is to find out the best dose, possible benefits and\u002For side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \\[CB\\]-NK-TGF-betaR2-\u002FNR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-\u002FNR3C1- cells are genetically changed immune cells that may help to control the disease.",[26,27,28],"Recurrent Gliosarcoma","Recurrent Supratentorial Glioblastoma","Supratentorial Gliosarcoma","RECRUITING","2026-01-22",{"date":32,"type":33},"2026-01-23","ACTUAL",{"date":35,"type":33},"2023-04-28",{"date":37,"type":20},"2027-01-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":41},"100529760","phase-2-lerapolturev-pvsripo-in-gbm-100529760","NCT06177964","Lerapolturev (PVSRIPO) in GBM","Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma (GBM)","Inclusion Criteria:\n\n1. Age ≥ 18 years old at the time of entry into the study.\n2. Histopathologically confirmed recurrent supratentorial glioblastoma (WHO grade 4) (high grade glioma with molecular features of glioblastoma will be eligible).\n3. Karnofsky Performance Score (KPS) ≥ 70%\n4. Hemoglobin ≥ 9 g\u002Fdl prior to biopsy\n5. Platelet count ≥ 100,000\u002Fµl unsupported is necessary for eligibility on the study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000\u002Fµl is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion.\n6. Neutrophil count ≥ 1000 prior to biopsy\n7. Creatinine ≤ 1.5 x normal range prior to biopsy\n8. Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)\n9. AST\u002FALT ≤ 2.5 x ULN\n10. Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy. Patients with prior history of thrombosis\u002Fembolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy.\n11. At the time of biopsy, prior to administration of the 1st infusion of lerapolturev via CED, the presence of recurrent tumor must be confirmed by histopathological analysis.\n12. Able to undergo brain MRI with and without contrast\n13. Prior CDC-recommended vaccination series against PV and has received a boost immunization with trivalent Poliovirus Vaccine Inactivated (IPOL®) (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to administration of lerapolturev. Note: Patients who are unsure of their prior vaccination status must provide evidence of anti-PV immunity prior to enrollment, as applicable.\n14. Patient or partner(s) meets one of the following criteria:\n\n    1. Non-childbearing potential (i.e., not sexually active, physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile, or any male who has had a vasectomy). Surgically sterile females are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study is defined as 1 year without menses.; or\n    2. Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g., a condom or diaphragm) used with spermicide.\n15. A signed informed consent form approved by the Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast-feeding\n2. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate\n3. Patients with severe, active co-morbidity, defined as follow:\n\n   1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C)\n   2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection\n   3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)\n   4. Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) \\\u003C 50%) disease or uncontrolled diabetes mellitus\n4. Known albumin allergy\n5. History of agammaglobulinemia\n6. Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks \\[except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\\] prior to starting the study drug unless patients have recovered from side effects of such therapy\n7. Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy\n8. Patients may not have received treatment with tumor treating fields (e.g., Optune®) ≤ 1 week prior to starting the study drug\n9. Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation\n10. Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)\n\n    1. If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\n    2. If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial\n11. Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease\n12. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the 1st lerapolturev infusion via CED\n13. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)\n14. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin\n15. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n16. Patients with known history of hypersensitivity to lomustine, dacarbazine, or any components of lomustine","18 Years",{"count":51,"type":20},92,[53],"PHASE2","The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.",[27],[57,58,59,60,61,62,63,64,65,66,67],"Lerapolturev","PVSRIPO","Lomustine","Shoaf","Glioblastoma","Glioma","Pro00113584","Duke","Istari Oncology","Intratumoral injection","Cervical Perilymphatic injection","2025-08-13",{"date":70,"type":33},"2025-08-17",{"date":72,"type":33},"2024-07-15",{"date":74,"type":20},"2029-02",{"name":76,"class":40},"Darell Bigner"]