[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Plus Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":132},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,77,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100600539","phase-1-multiple-dose-intraventricular-administration-of-rhenium-186-nanoliposome-for-leptomeningeal-metastases-100600539",false,"NCT07098806","Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases","A Multicenter Phase 1 Study to Determine the Safety and Efficacy of Multiple Doses at Defined Intervals of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Administered Via Intraventricular Catheter for Any Primary Solid Tumor Cancer With Leptomeningeal Metastases","CA2024-LM-001","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.\n3. Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C).\n4. Karnofsky performance status of 70 to 100.\n5. Acceptable liver function:\n\n   1. Bilirubin ≤ 1.5 times the upper limit of normal.\n   2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for subjects with normal liver.\n   3. AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for subjects with liver metastasis.\n6. Acceptable renal function:\n\n   a. Creatinine clearance greater than or equal to 60 mL\u002Fmin (using the Cockcroft-Gault Equation).\n7. Acceptable hematologic functioning (without hematologic support):\n\n   1. ANC ≥ 1000 cells μL.\n   2. Platelet count ≥ 75,000\u002FμL.\n   3. Hemoglobin ≥ 9.0 g\u002FdL.\n8. All women of childbearing potential must have a negative serum pregnancy test at screening. Male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.\n9. Normal CSF flow and distribution by an accepted CSF flow study (e.g., 111Indium-DTPA or acceptable substitute) before first treatment with the study drug, based on study imaging interpretation and clinical correlation.\n10. Corticosteroids are permitted as clinically indicated.\n\nExclusion Criteria:\n\n1. The subject has not recovered to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study, at time of study registration.\n\n   a. Prior AEs due to alopecia, anemia, neutropenia, and lymphopenia are not required to be recovered to Grade ≤1 prior to study registration, assuming other inclusion criteria are satisfied.\n2. Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)\n3. Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.\n4. Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see inclusion criteria).\n5. Serious intercurrent illnesses, which could interfere with the planned treatment schedule.\n6. Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except:\n\n   1. Prior radiation dose to the spinal cord and\u002For cauda equina is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to the spinal cord and\u002For cauda equina using α\u002Fβ ratio of 3 and if prior radiotherapy has been \\> 14 days and ≤ 6 months, or was ≤45 Gy to the spinal cord and\u002For cauda equina using α\u002Fβ ratio of 3 and if prior radiotherapy has been \\> 6 months.\n   2. Prior stereotactic radiosurgery (SRS) to the brain or partial brain radiotherapy is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to brainstem and\u002For optic structures (optic nerves, optic chiasm) using α\u002Fβ ratio of 3 and if prior radiotherapy has been \\> 14 days and ≤ 6 months, or was ≤ 45 Gy to the brainstem and\u002For optic structures (optic nerves, optic chiasm) using α\u002Fβ ratio of 3 and if prior radiotherapy has been \\> 6 months.\n7. Prior or concurrent therapy:\n\n   a. Intrathecally delivered therapy: i. Concurrent: Concurrent intrathecal therapy. ii. Prior: Intrathecal therapy given less than 14 days before study registration.\n\n   b. Systemically delivered therapy: i. Concurrent: Systemically delivered therapy UNLESS LM develops while on systemically delivered therapy AND the systemically delivered therapy is NOT associated with more than grade 1 myelosuppression.\n\n   ii. Prior: Systemically delivered therapy given less than 28 days before study registration.\n8. Projected survival of less than 60 days.","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD\u002FMFD for a given dose, interval duration, and number of doses.",[27],"Leptomeningeal Metastasis",[29,30,31,32,33,34,35,36,37,38],"Neoplastic Processes Neoplasms","Neoplasms","Pathologic Processes","Meningeal Neoplasms","Central Nervous System Neoplasms","Nervous System Neoplasms","Neoplasms by Site","Nervous System Diseases","Neoplasm Metastasis","Meningeal Carcinomatosis","RECRUITING","2025-07-29",{"date":42,"type":43},"2025-08-01","ACTUAL",{"date":45,"type":43},"2025-07-02",{"date":47,"type":21},"2031-10-02",{"name":49,"class":50},"Plus Therapeutics","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100597679","phase-1-determine-maximum-tolerated-dose-safety-and-tolerability-of-rhenium-186re-in-pediatric-recurrent-refractory-or-progressive-ependymoma-and-high-grade-glioma-100597679","NCT07061626","Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma","A Two-Part, Phase 1\u002F2a Trial to Determine the Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Delivered Via Convection Enhanced Delivery (CED) in Supratentorial Recurrent, Refractory, or Progressive Pediatric Ependymoma and High-Grade Glioma (HGG)","Inclusion Criteria:\n\n1. 6 years to 21 years\\* of age.\n2. Lesion number and size:\n\n   1. Phase 1a\u002Fb only: A single lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor (subsequent to individual Cohort lesion size requirements).\n   2. Phase 2a only: A single lesion or any number of multiple lesions separated by (less than or equal to) ≤3 cm; each lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor.\n3. Diagnosis:\n\n   a) Documented recurrent, refractory, or progressive ependymoma or HGG not eligible for resection or no longer receiving standard of care.\n\n   i) Phase 2a only: May include patients with recurrent, refractory, or progressive ependymoma or HGG where SOC surgery could be safely delayed four (4) weeks post-infusate.\n\n   b) Documented histologically confirmed high-grade glioma \\[following 2021 WHO CNS5 glioma nomenclature, e.g., Anaplastic astrocytoma, Anaplastic pleomorphic xanthoastrocytoma (PXA), Anaplastic ganglioglioma, Anaplastic oligodendroglioma, Glioblastoma, Diffuse midline glioma, H3K27M mutant\\].\n4. Karnofsky Performance Status ≥ 60. For subjects \\\u003C16 years of age, Lansky score ≥ 60.\n5. Acceptable liver function:\n\n   1. Bilirubin ≤ 1.5 times the upper limit of normal\n   2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal (ULN)\n\n      6\\) Acceptable renal function:\n\n   \u003C!-- -->\n\n   1. Serum creatinine ≤1.5xULN\n\n7\\. Acceptable hematologic status (without hematologic support):\n\n1. ANC ≥1000 cells\u002FuL\n2. Platelet count ≥100,000\u002FuL\n3. Hemoglobin ≥9.0 g\u002FdL\n\n   8\\. All subjects of childbearing potential must have a negative serum pregnancy test, and subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.\n\n   9\\. Life expectancy of at least 2 months.\n\n   \\*Will consider treatment of subjects up to 25 years of age on a per-patient basis if no other co-morbidities are present that require subspecialty consultation outside of neurosurgical and oncologic care.\n\nExclusion Criteria:\n\n1. Spinal disease.\n2. Infratentorial location of tumor.\n3. Involvement of the leptomeninges.\n4. Serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes such as:\n\n   1. Hypertension (two or more blood pressure readings performed at screening of systolic blood pressure (SBP) or diastolic blood pressure (DBP) above 95th percentile for age) despite optimal treatment.\n   2. Active medically significant infection unresponsive to antibiotics (e.g., non-healing wound, ulcer), uncontrolled systemic infection, or bone fracture.\n   3. Clinically significant cardiac arrhythmias.\n   4. Untreated hypothyroidism.\n   5. Congestive heart failure.\n   6. Myocarditis.\n   7. Inherited bleeding diathesis or coagulopathy with the risk of bleeding.\n   8. Known active malignancy other than ependymoma or high-grade glioma.\n5. Any of the following prior anticancer therapy:\n\n   1. Prior treatment with Bevacizumab or other VEGF agents within 12 months prior to study registration.\n   2. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site at any time prior to study registration.\n   3. Standard radiation therapy within 12 weeks prior to study registration.\n   4. Any systemic therapy within 28 days or 2 half-lives, whichever is longer, prior to study registration (this may include investigational agents, small-molecule kinase inhibitors, non-cytotoxic hormonal therapy, biologic agents, metronomic\u002Fprotracted low-dose chemotherapy, etc.).\n   5. Nitrosoureas or mitomycin C within 42 days prior to study registration.\n6. Psychiatric illness\u002Fsocial situations that would limit compliance with the study requirements.\n7. A tumor located within 1.0cm of a ventricle AND it is determined by the surgeon, PI, and Sponsor to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug administration.\n8. A tumor within 1.5cm of critical structures, including the optic chiasm, optic nerves, or brainstem.\n9. Evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan (subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible).\n10. Treatment with antiepileptic medications must have a two-week history of a stable dose of antiepileptic without seizures prior to study registration.\n11. Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms prior to study registration.","6 Years","21 Years",{"count":62,"type":21},56,[24],"Pediatric patients 6-21 years of age with supratentorial recurrent, refractory, or progressive pediatric ependymoma and high-grade glioma (HGG) will be included in this study of treatment with Rhenium-186 Nanoliposome (186RNL). Phase 1 of the study will look to determine the maximum tolerated dose (MTD) of 186RNL in this patient population. Phase 2 of the study will use the recommended dose determined in Phase 1 to continue to look at overall response rate and progression-free survival following 186RNL treatment.",[66,67],"Ependymoma","High Grade Gliomas","NOT_YET_RECRUITING","2025-07-10",{"date":71,"type":43},"2025-07-11",{"date":73,"type":21},"2025-09",{"date":75,"type":21},"2027-03",{"name":49,"class":50},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":51},"100474638","phase-1-safety--efficacytolerability-of-rhenium-186-nanoliposomes-186rnl-for-patients-who-received-a-prior-186rnl-treatment-100474638","NCT05460507","Safety & Efficacy\u002FTolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment","A Single Arm Open Label Study to Determine the Safety and Efficacy\u002FTolerability of Rhenium-186 NanoLiposomes (186RNL) for Recurrence of Glioma in Patients Who Received a Prior Treatment With 186RNL","Inclusion Criteria:\n\n1. At least 18 years of age at time of screening.\n2. Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.\n3. Patient must present with biopsy and histology proven glioma following initial treatment with 186RNL. The type and grade of glioma to follow the 2021 WHO Classification of Tumors of the Central Nervous System, allowing Grade III and IV gliomas.\n4. At least 90 days from prior dose of 186RNL at time of screening.\n5. Patients who receive treatment with antiepileptic medications must have a two-week history of stable dose of antiepileptic without seizures prior to dosing.\n6. Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms.\n7. A volume of enhancing tumor which falls within the treatment field volume being evaluated in the respective cohort (see 4.1 Design).\n8. ECOG performance status of 0 to 2; ECOG 3 acceptable if Principal Investigator and treating physician confirm in patient's interest in study\u002Fre-treatment.\n9. Life expectancy of at least 2 months\n10. Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal and AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)\n11. Acceptable renal function: Serum creatinine ≤1.5xULN\n12. Acceptable hematologic status (without hematologic support): ANC ≥1000 cells\u002FuL, Platelet count ≥100,000\u002FuL if no bleeding, Hemoglobin ≥7.0 g\u002FdL. Given the absence of hematological toxicity in the ongoing recurrent glioblastoma trial (#12-02) and the need for CED catheter placement, the Investigator and Sub-investigator (neurosurgeon) placing the CED catheter may determine that it is in the patient's best interest and acceptably safe to proceed with this criteria with hematological support or, if no bleeding, Platelet count ≥75,000\u002FuL without support, ANC 1000 cells\u002FuL and Hemoglobin ≥7.0 g\u002FdL\n13. All women of childbearing potential must have a negative serum pregnancy test at screening. Male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.\n14. Patients must have malignant glioma that has progressed on or after standard treatment (surgery, radiotherapy, and\u002For chemotherapy) and are planned to undergo stereotactic biopsy as per standard of care.\n\nExclusion Criteria:\n\n1. The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.\n2. The subject has contraindications to CNS Magnetic Resonance Imaging (MRI).\n3. The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for any prior Adverse Events (CTCAE) v4.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study.\n4. The subject is pregnant or breast-feeding.\n5. The subject has serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety include:\n\n   1. Uncontrolled hypertension (two or more blood pressure readings performed at screening of \\> 150 mmHg systolic or \\> 100 mmHg diastolic) despite optimal treatment\n   2. non-healing wound, ulcer, or bone fracture\n   3. clinically significant cardiac arrhythmias affecting cardiac function\n   4. untreated hypothyroidism\n   5. uncontrolled systemic infection\n   6. symptomatic congestive heart failure or unstable, untreated angina pectoris within 3 months prior study drug\n   7. myocardial infarction, stroke, transient ischemic attack within 6 months\n   8. known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix\n6. The subject has an inherited bleeding diathesis or coagulopathy with the risk of bleeding.\n7. The subject has received any of the following prior anticancer therapy:\n\n   1. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site.\n   2. Other CNS radiation therapy within 12 weeks of screening.\n   3. Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior first dose of study drug\n   4. Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug\n   5. Nitrosoureas or mitomycin C within 42 days, or metronomic\u002Fprotracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\n   6. Prior CNS treatment with carmustine wafers\n   7. Patients who are currently receiving any other investigational agents and\u002For who have received an investigational agent in the prior 28 days from screening.\n   8. Patient actively enrolled in an ongoing investigational drug or device trial excluding follow-up only in a previously trial.\n8. Multifocal progression or involvement of the leptomeninges.\n9. Psychiatric illness\u002Fsocial situations that would limit compliance with the study requirements.\n10. Infratentorial disease unless Investigator and neurosurgeon agree it is treated disease.",{"count":85,"type":21},40,[24],"This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy\u002Ftolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.",[89],"Glioma",[89,91,92,93,94,95,96,97,98,99,100,101],"Brain Tumor","Radiotherapy","Glioblastoma","Recurrent Glioblastoma","Rhenium","Rhenium Nanoliposome","Brain Cancer","GBM","High Grade Glioma","Glioblastoma Multiform","Grade IV Astrocytoma","2025-03-25",{"date":104,"type":43},"2025-03-30",{"date":106,"type":43},"2024-12-12",{"date":108,"type":21},"2028-03-01",{"name":49,"class":50},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100202029","phase-1-maximum-tolerated-dose-safety-and-efficacy-of-rhenium-nanoliposomes-in-recurrent-glioma-respect-100202029","NCT01906385","Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)","A Dual Phase 1\u002F2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB\u002FEthics Committee.\n3. Histologically confirmed Grade III\u002FIV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Glioblastoma, IDH-wildtype grade 4).\n4. Progression by RANO criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefit for any recurrence (e.g., surgery, temozolomide, radiation, and tumor treating fields). Patient may be included in study if medically unable or unwilling to follow standard treatment options for any recurrence.\n5. Patients who receive treatment with antiepileptic medications must have a two-week history of stable dose of antiepileptic without seizures prior to study start (dosing).\n6. Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms prior to study start (dosing).\n7. Patients with Grade III\u002FIV Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Glioblastoma, IDH-wildtype grade 4) which falls within the treatment field volume.\n8. ECOG performance status of 0 to 2; Karnofsky Performance Status ≥ 60.\n9. Life expectancy of at least 2 months.\n10. Acceptable liver function:\n\n    1. Bilirubin ≤ 1.5 times upper limit of normal\n    2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)\n11. Acceptable renal function:\n\n    a. Serum creatinine ≤1.5xULN\n12. Acceptable hematologic status (without hematologic support):\n\n    1. ANC ≥1000 cells\u002FuL\n    2. Platelet count ≥100,000\u002FuL\n    3. Hemoglobin ≥9.0 g\u002FdL\n13. All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.\n\nExclusion Criteria:\n\n1. The subject has evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.\n2. The subject is unable or contraindicated to undergo MRI scan (e.g., has pacemaker or medically unstable).\n3. The subject has not recovered to CTCAE v4.0 Grade ≤1 from AEs (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study.\n4. The subject is pregnant or breast-feeding.\n5. The subject has serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes such as:\n\n   * hypertension (two or more blood pressure readings performed at screening of \\>150 mmHg systolic or \\>100 mmHg diastolic) despite optimal treatment\n   * active medically significant infection unresponsive to antibiotics (e.g., non- healing wound, ulcer), uncontrolled systemic infection, or bone fracture\n   * clinically significant cardiac arrhythmias not controlled by appropriate medications\n   * untreated hypothyroidism\n   * symptomatic congestive heart failure or unstable angina pectoris within 3 months prior to study drug\n   * myocardial infarction, stroke, or transient ischemic attack within 6 months prior to study drug\n   * known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix unless PI determines it would not impact patient safety or efficacy determinations\n6. The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.\n7. The subject has received any of the following prior anticancer therapy:\n\n   * Prior treatment with Bevacizumab\n   * Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site\n   * Radiation therapy within 12 weeks of screening\n   * Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior to study start (dosing)\n   * Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to study start (dosing)\n   * Nitrosoureas or mitomycin C within 42 days, or metronomic\u002Fprotracted low- dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to study start (dosing)\n   * Prior treatment with carmustine wafers\n   * Patients who are currently receiving any other investigational agents and\u002For who have received an investigational agent in 28 days prior to study start (dosing)\n8. Multifocal progression or involvement of the leptomeninges.\n9. Psychiatric illness\u002Fsocial situations that would limit compliance with the study requirements\n10. Infratentorial disease\n11. The subject has a tumor located within 1-2 cm of a ventricle AND it is determined by the surgeon, PI, and sponsor to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug administration.\n12. Phase 2 only: The subject should have a tumor volume of ≤20 cm3 to be included in the Phase 2 portion of the study. Subjects with tumor volumes of greater than 20 cm3 are excluded from the Phase 2 portion of the study.",{"count":118,"type":21},55,[24,120],"PHASE2","This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and\u002For chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.",[89],[89,91,92,93,94,95,96,97,98,99,100,101],{"date":125,"type":43},"2025-03-26",{"date":127,"type":43},"2015-06-03",{"date":129,"type":21},"2025-12",{"name":49,"class":50},3,""]