[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00107289":3,"trial-entities:NCT00107289":109,"trial-summary:NCT00107289":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":43,"sex":46,"minimum_age":47,"maximum_age":15,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":71,"locations":75,"central_contacts":93,"overall_officials":96,"references":98,"see_also_links":106},"NCT00107289","04-148","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","RECRUITING","2027-05","2026-05","2026-05-29","2006-05","Memorial Sloan Kettering Cancer Center","OTHER",null,"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.",[18,19],"Neuroblastoma","Pheochromocytoma",[21,22,23,24,5],"metastatic pheochromocytoma","recurrent pheochromocytoma","regional pheochromocytoma","recurrent neuroblastoma","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},200,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"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.",[38],"Radiation",[40],{"measure":41,"timeFrame":42},"Response (complete or partial)","2 years",[44],{"measure":45,"timeFrame":42},"Correlation between tumor self-absorbed dose and response and tumor volume decrease","ALL","1 Year",false,{"inclusion":50,"exclusion":65,"raw_text":70},[51,52,53,54,55,56,57,58,59,60,61,54,62,63,64,59],"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.","Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.","Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol","Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.","Age \\>1 year","Determination that radiation safety restrictions during therapy period can be implemented.","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.","Minimum life expectancy of eight weeks","Signed informed consent indicating awareness of the investigational nature of this program.","Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma","Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol","Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period","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.","Minimum life expectancy of eight weeks.",[66,67,68,69],"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.","Active serious infections not controlled by antibiotics.","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.","Inability or unwillingness to comply with radiation safety procedures or protocol requirements.","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.",[72,73,74],"CHILD","ADULT","OLDER_ADULT",[76],{"facility":13,"status":8,"city":77,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":90},"New York","10065","United States",[81,85,88],{"name":82,"role":83,"phone":84},"Ellen Basu, MD, PhD","CONTACT","212-639-5204",{"name":86,"role":83,"phone":87},"Shakeel Modak, MD","212-639-7623",{"name":82,"role":89},"PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},40.71427,-74.00597,[94,95],{"name":82,"role":83,"phone":84},{"name":86,"role":83,"phone":87},[97],{"name":82,"affiliation":13,"role":89},[99,103],{"pmid":100,"type":101,"citation":102},"26773712","DERIVED","Chu BP, Horan C, Basu E, Dauer L, Williamson M, Carrasquillo JA, Pandit-Taskar N, Modak S. Feasibility of Administering High-Dose (131) I-MIBG Therapy to Children with High-Risk Neuroblastoma Without Lead-Lined Rooms. Pediatr Blood Cancer. 2016 May;63(5):801-7. doi: 10.1002\u002Fpbc.25892. Epub 2016 Jan 15.",{"pmid":104,"type":101,"citation":105},"26742708","Modak S, Zanzonico P, Carrasquillo JA, Kushner BH, Kramer K, Cheung NK, Larson SM, Pandit-Taskar N. Arsenic Trioxide as a Radiation Sensitizer for 131I-Metaiodobenzylguanidine Therapy: Results of a Phase II Study. J Nucl Med. 2016 Feb;57(2):231-7. doi: 10.2967\u002Fjnumed.115.161752. Epub 2016 Jan 7.",[107],{"label":13,"url":108},"http:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":110,"biomarkers":113},[111,18,112],"Adrenal Gland Pheochromocytoma","Paraganglioma",[114],"C-X-C Motif Chemokine 9",{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll up to 200 participants.","completed","Iodine I 131 Metaiodobenzylguanidine for Neuroblastoma or Pheochromocytoma","This study is testing the safety and effectiveness of a drug called iodine I 131 metaiodobenzylguanidine (also known as 131I-MIBG) in patients with certain types of cancer. These include neuroblastoma (a cancer that forms in nerve tissue), malignant pheochromocytoma (a rare tumor of the adrenal gland), or malignant paraganglioma (a rare tumor that forms near the adrenal glands or in other parts of the body). You may be able to join if you are at least 1 year old and your cancer has come back, gotten worse, or hasn't responded to standard treatments. The researchers want to see if this treatment can shrink or get rid of the cancer, with results measured over two years. The current status of this study is unclear, and it plans to enroll up to 200 patients.","The primary endpoint, which measures the treatment's response, is assessed at 2 years.",132,"Participants will receive a single dose of iodine I 131 metaiodobenzylguanidine intravenously. Radiation measurements will be taken to see if a second dose can be given safely.","Not stated in the trial record.",[],"v2"]