[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100065755":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiation","EXPERIMENTAL","Patients will be treated with IV 131I-MIBG using 1-2 high dose(s) or up to 16 low doses.\n\nThyroid protection is commenced seven days (+\u002F-2 days) prior to administration of 131I-MIBG and continued for up to 42 days after each 131I-MIBG treatment. Given that this is an open access protocol, re-enrollment is allowed per PI discretion. Patients who received this treatment previously are allowed to be re-enrolled if they meet the eligibility criteria. Re-enrollment can be to the same arm previously treated on (high dose versus low dose) or to the other arm. Patients will not be eligible for re-enrollment if they have already received 16 low doses or 4 high doses of 131I-MIBG.",[13],"Drug: iobenguane I 131",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","iobenguane I 131","A single dose of iodine I 131 metaiodobenzylguanidine (\\^131I-MIBG) IV over 30 minutes to 4 hours or for 15 minutes for smaller patients on day 0. Patients undergo radiation dosimetry following the first dose of \\^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (\\^131I-MIBG) 6-8 weeks after the first dose. In some scenarios, extended time will be allowed before the second dose of 131I-MIBG for additional recovery and possible bridging therapy. If response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 μCi\u002FmL, patients may undergo autologous stem cell transplantation. After completion of study treatment, patients are followed at 4-6 weeks after \\^131I-MIBG administration and then every 3 months for up to 1 year. Once patients are off treatment on this protocol, they will begin long term follow up through 5 years from enrollment.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Ellen Basu, MD, PhD","PRINCIPAL_INVESTIGATOR",[26,29],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},"CONTACT","212-639-5204",{"name":30,"role":27,"phone":31,"phoneExt":20,"email":20},"Shakeel Modak, MD","212-639-7623",[33],{"facility":5,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","New York","10065","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-74.00597,40.71427,{"lat":43,"lon":42},[46,47,48],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"name":30,"role":27,"phone":31,"phoneExt":20,"email":20},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"National Cancer Institute (NCI)","NIH","100065755","phase-2-iodine-i-131-metaiodobenzylguanidine-in-treating-patients-with-recurrent-progressive-or-refractory-neuroblastoma-or-malignant-pheochromocytoma-or-paraganglioma-100065755",false,"NCT00107289","Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma","Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors","Inclusion criteria for NB:\n\n* Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.\n* Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.\n* Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol\n* Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.\n* Age \\>1 year\n* Determination that radiation safety restrictions during therapy period can be implemented.\n* Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells\u002Fkg.\n* Minimum life expectancy of eight weeks\n* Signed informed consent indicating awareness of the investigational nature of this program.\n\nInclusion criteria for malignant CCT:\n\n* Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma\n* Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol\n* Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.\n* Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period\n* Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells\u002Fkg.\n* Minimum life expectancy of eight weeks.\n* Signed informed consent indicating awareness of the investigational nature of this program.\n\nExclusion Criteria:\n\n* Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable.\n* Active serious infections not controlled by antibiotics.\n* Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.\n* Inability or unwillingness to comply with radiation safety procedures or protocol requirements.","ALL","1 Year",{"count":65,"type":66},200,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.",[72,73],"Neuroblastoma","Pheochromocytoma",[75,76,77,78,79],"metastatic pheochromocytoma","recurrent pheochromocytoma","regional pheochromocytoma","recurrent neuroblastoma","04-148","2026-05-28",{"date":82,"type":83},"2026-05-29","ACTUAL",{"date":85,"type":83},"2006-05",{"date":87,"type":66},"2027-05",{"name":5,"class":6},1]