[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Darell Bigner\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,80,105],{"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":27,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100404547","phase-1-phase-1-trial-of-d2c7-it-in-combination-with-2141-v11-for-recurrent-malignant-glioma-100404547",false,"NCT04547777","Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma","A Phase 1 Trial of D2C7-IT in Combination With an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) Administered Intratumorally Via Convection-Enhanced Delivery Followed by Perilymphatic Injections of 2141-V11 and Assessment of the Tumor Monorail for Adult Patients With Recurrent Malignant Glioma","Inclusion Criteria:\n\n1. Study population:\n\n   1. Subgroup #2: Histopathologically confirmed recurrent supratentorial WHO grade 3 or 4 malignant glioma (high grade glioma with molecular features of glioblastoma will be eligible under WHO grade 4 malignant glioma)\n   2. Subgroup #3: Histopathologically confirmed recurrent supratentorial WHO grade 4 malignant glioma (high grade glioma with molecular features of glioblastoma will be eligible under WHO grade 4 malignant glioma) and found amenable for Tumor Monorail Device (TMD) implantation as per the treating neurosurgeon\n2. Patient or partner(s) meets one of the following criteria:\n\n   1. Non-childbearing potential (i.e.) not sexually active, physiologically incapable of becoming pregnant, including people who are post-menopausal or surgically sterile. Surgically sterile people are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation or have had a vasectomy. Postmenopausal for purposes of this study is defined as 1 year without menses.; or\n   2. Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide.\n3. Age ≥ 18 years of age at the time of entry into the study\n4. Karnofsky Performance Score (KPS) ≥ 70%\n5. Hemoglobin ≥ 9 g\u002Fdl prior to biopsy\n6. Platelet count ≥ 100,000\u002Fµl unsupported is necessary for eligibility on the study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000\u002Fµl is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion\n7. Neutrophil count ≥ 1000 prior to biopsy\n8. Creatinine ≤ 1.5 x normal range prior to biopsy\n9. Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)\n10. AST\u002FALT ≤ 2.5 x ULN\n11. Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy. Patients with prior history of thrombosis\u002Fembolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy.\n12. At the time of biopsy, prior to administration of D2C7-IT, the presence of recurrent tumor must be confirmed by histopathological analysis\n13. A signed informed consent form approved by the Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study\n14. Able to undergo brain MRI with and without contrast\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breastfeeding\u002Fchestfeeding\n2. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate\n3. Patients with severe, active co-morbidity, defined as follow:\n\n   1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C)\n   2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection\n   3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)\n   4. Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) \\\u003C 50%) disease or uncontrolled diabetes mellitus\n   5. Patients with albumin allergy\n4. Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks \\[except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\\] prior to starting the study drug unless patients have recovered from side effects of such therapy\n5. Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy\n6. Patients may not have received treatment with tumor treating fields (e.g., Optune) ≤ 1 week prior to starting the study drug\n7. Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation\n8. Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)\n\n   1. If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\n   2. If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial\n9. Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease\n10. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the D2C7-IT infusion\n11. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)\n12. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin\n13. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n14. Only for patients in Subgroup #3 (TMD subgroup): Patients with known allergies to silicone, polyurethane and titanium, which are materials contained in the TMD\n\nSubject Eligibility Salvage Treatment (Effective with Protocol Version v.5.0)\n\nBefore being allowed to proceed with salvage treatment, the subject must satisfy the following inclusion and exclusion criteria. This option is available only for patients treated prior to Protocol Version v.5.0 - Subgroup #1:\n\nInclusion Criteria Salvage Treatment\n\n1. Patients must have a recurrence of their supratentorial WHO grade IV4 malignant glioma based on imaging studies with measurable disease requiring therapy other than per protocol allowed reduced dose bevacizumab\n2. Patients must be ≥ 4 months since their intratumoral administration of D2C7-IT + 2141-V11\n3. A new signed informed consent form for the treatment with 2141-V11 in the CPL area ipsilateral to the tumor approved by the Institutional Review Board (IRB) of record will be required. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of the injection of 2141-V11 in the CPL subcutaneous area.\n4. If the subject is able to produce sperm and is sexually active, they are eligible to enter and receive treatment with 2141-V11 injected in the CPL subcutaneous area if their partner(s) meets the criteria outlined in sub-bullet a. below or if they or their partner(s) are using one of the methods of birth control outlined in sub-bullet b. below. If the subject is potentially able to become pregnant, they are eligible to enter and participate in this study if they meet the following criteria:\n\n   1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including people who are postmenopausal or surgically sterile). Surgically sterile people are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study, is defined as 1 year without menses); or\n   2. Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g., birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g., a condom or diaphragm) used with spermicide.\n   3. Please note: If the patient has had a vasectomy or is using a condom with spermicide, their partner does not need to use additional birth control noted in 4a and 4b.\n5. Total bilirubin ≤ 1.5 x ULN prior to CPL injection (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)\n6. AST\u002FALT ≤ 2.5 x ULN prior to CPL injection.\n7. Neutrophil count ≥ 1000 prior to CPL injection.\n8. Platelet count ≥ 50,000\u002FµL unsupported is necessary prior to CPL injection.\n9. Creatinine ≤ 1.2 x normal range prior to CPL injection.\n\nExclusion Criteria Salvage Treatment\n\n1. Patients who are pregnant or breastfeeding\u002Fchestfeeding\n2. Patients with severe, active co-morbidity, defined as follow:\n\n   1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C)\n   2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection\n   3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)\n   4. Patients with known lung (forced expiratory volume in the first second of expiration \\[FEV1\\] \\\u003C 50%) disease or uncontrolled diabetes mellitus\n3. Karnofsky Performance Score \\\u003C 60%\n4. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the 2141-V11 injection in the CPL area\n5. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.",[26],"Glioma, Malignant",[28,29,30,31,32,33,34,35,36,37,38,39],"D2C7","D2C7-IT","Glioblastoma","Glioma","2141-V11","Pro00104852","Duke","Rockefeller","CD40","epidermal growth factor receptor (EGFR)","EGFR","Landi","RECRUITING","2026-06-03",{"date":43,"type":44},"2026-06-04","ACTUAL",{"date":46,"type":44},"2021-07-09",{"date":48,"type":20},"2028-06",{"name":50,"class":51},"Darell Bigner","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":52},"100551093","phase-1-d2c7-it--2141-v11-combination-post-resection-in-rgbm-100551093","NCT06455605","D2C7-IT + 2141-V11 Combination Post-resection in rGBM","Clinical Trial of D2C7-IT + 2141-V11 Combination Immunotherapy Administered Via Convection Enhanced Delivery in Non-enhancing Tumor Post-resection of Recurrent Glioblastoma, Followed by Cervical Perilymphatic Subcutaneous Injections of 2141-V11","Inclusion Criteria:\n\n1. Age ≥ 18 years old at the time of entry into the study\n2. Histopathologically confirmed WHO grade 4 IDHwt GBM (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 surgical resection and biopsy.\n11. Patient must have undergone resection per the recommendation of their treating physician 3-5 weeks prior to administration of D2C7-IT, and the presence of recurrent tumor must have been confirmed by histopathological analysis.\n12. Able to undergo brain MRI with and without contrast\n\n    a. Post-surgery MRI must demonstrate a residual area of non-enhancing disease that is amenable to CED infusion (no larger than 3 x 3 cm of residual enhancing disease per screening MRI)\n13. 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.\n14. A signed ICF approved by the IRB will be required for patient enrollment into the study. Patients must be able to read and understand the ICF and must sign the ICF indicating that they are aware of the investigational nature of this study\n\nExclusion Criteria:\n\n1. Females who are pregnant (negative pregnancy test at screening visit) 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\n   5. Patients with albumin allergy\n4. Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks \\[except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\\] prior to starting the study drug unless patients have recovered from side effects of such therapy\n5. Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy\n6. Patients may not have received treatment with tumor treating fields (e.g., Optune®)\n\n   * 1 week prior to starting the study drug\n7. Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation\n8. Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)\n\n   1. If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\n   2. If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial\n9. Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease\n10. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the D2C7-IT infusion\n11. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)\n12. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin\n13. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n14. Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies (i.e. pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates)",{"count":61,"type":20},46,[23],"The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT+2141-V11 administered in the non-enhancing tumor of patients with resected recurrent glioblastoma (rGBM) via convection enhanced delivery (CED), followed by subcutaneous cervical perilymphatic injections (CPLIs) of 2141-V11 2 and 4 weeks post infusion, then every 3 weeks for a year, and every 4-6 weeks thereafter if patients benefit from therapy.",[65],"Recurrent Glioblastoma IDH Wildtype",[28,29,32,67,68,30,69,70,71],"Pro00115800","GBM","convection-enhanced delivery","CED","IDHwt","2025-10-21",{"date":74,"type":44},"2025-10-23",{"date":76,"type":44},"2025-03-17",{"date":78,"type":20},"2030-01-31",{"name":50,"class":51},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":52},"100495696","phase-1-d2c7-it-and-2141-v11-in-newly-diagnosed-gbm-patients-100495696","NCT05734560","D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients","Delivery of D2C7-IT and 2141-V11 Combination Immunotherapy in Residual Disease for Adult Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma and Perilymphatic Subcutaneous Injections of 2141-V11","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at the time of entry into the study\n2. Newly diagnosed supratentorial GBM, WHO grade 4, IDH wildtype, MGMT unmethylated (high grade glioma with molecular features of GBM will be eligible under WHO 4 malignant glioma) with residual radiographic non-contrast enhancing disease on the post-2 cycles of adjuvant TMZ MRI amenable to catheter placement. The residual radiographic contrast enhancing disease is ≤ 3 cm in maximal diameter in any plane.\n3. Patient must have completed standard of care radiation therapy (typically 59.4-60 Gy over approximately 6 weeks duration if under 65 years old and a minimum of 40 Gy over 3 weeks duration if 65 years or older) in combination with TMZ and 2 cycles of post-radiation, adjuvant TMZ. For patients known to be MGMT promoter unmethylated prior to start of radiation therapy, patients are not mandated to have received TMZ in combination to radiation therapy prior to participating in this trial.\n4. Karnofsky Performance Score (KPS) \\> 70%\n5. Able to undergo brain MRI wiht and without contrast\n6. Hemoglobin ≥ 9 g\u002Fdl prior to catheter placement\n7. Platelet count ≥ 100,000\u002FµL unsupported. 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\n8. Neutrophil count ≥ 1000 prior to catheter placement\n9. Creatinine ≤ 1.5 x normal range prior to catheter placement\n10. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) prior to catheter placement (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.)\n11. AST\u002FALT ≤ 2.5 x ULN\n12. PT and PTT ≤ 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.\n13. 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 person who is post-menopausal or surgically sterile, or any person who has had a vasectomy). Surgically sterile people are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study is defined as 1 year without menses.; or\n    2. Childbearing potential 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\n14. A signed ICF approved by the 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. Patients who are pregnant or breast-feeding\u002Fchestfeeding\n2. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate\n3. Patients with severe, active comorbidity, defined as follows:\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 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\n   5. Patients with uncontrolled diabetes mellitus\n   6. Patients with albumin allergy\n   7. Patients with known HIV or Hepatitis C positive status\n   8. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy\n4. Patients who previously received other therapeutic interventions for newly diagnosed GBM with the exception of surgical resection and standard of care concomitant radiation therapy and TMZ and 2 cycles of post-radiation, adjuvant TMZ for their brain tumor\n5. Patients who have received concomitant radiation therapy and TMZ ≤ 11 weeks prior to start of D2C7-IT CED infusion\n6. Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of (actively growing) multifocal disease, tumor crossing the midline, extensive subependymal disease, or leptomeningeal disease\n7. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the start of D2C7-IT infusion\n8. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)\n9. 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\n10. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n11. Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies (i.e. pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates) or patients with any known severe allergies to contrast agents. Patients with mild allergies (i.e., rash only) are allowed to enroll and will be pretreated with acetaminophen and diphenhydramine prior to injection of the contrast agent.",{"count":88,"type":20},50,[23,90],"PHASE2","The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word \"investigational\" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).",[93],"Newly Diagnosed MGMT Unmethylated Glioblastoma",[28,29,32,95,68,30,69,70,96],"Pro00110119","MGMT unmethylated","2025-10-02",{"date":99,"type":44},"2025-10-06",{"date":101,"type":44},"2023-09-06",{"date":103,"type":20},"2028-10-31",{"name":50,"class":51},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":52},"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",{"count":113,"type":20},92,[90],"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.",[117],"Recurrent Supratentorial Glioblastoma",[119,120,121,122,30,31,123,34,124,125,126],"Lerapolturev","PVSRIPO","Lomustine","Shoaf","Pro00113584","Istari Oncology","Intratumoral injection","Cervical Perilymphatic injection","2025-08-13",{"date":129,"type":44},"2025-08-17",{"date":131,"type":44},"2024-07-15",{"date":133,"type":20},"2029-02",{"name":50,"class":51},""]