Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-06 @ 6:57 AM
Study NCT ID:
NCT01175356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018305', 'term': 'Ganglioneuroblastoma'}, {'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D019797', 'term': '3-Iodobenzylguanidine'}, {'id': 'D015474', 'term': 'Isotretinoin'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D007462', 'term': 'Iodobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006847', 'term': 'Hydrocarbons, Iodinated'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (131I-MIBG, Chemotherapy)', 'description': 'Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.', 'otherNumAtRisk': 98, 'otherNumAffected': 86, 'seriousNumAtRisk': 98, 'seriousNumAffected': 27}], 'otherEvents': [{'term': '13200-Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 49, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33300-Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 81, 'numAffected': 54}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20000-Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '78900-Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '38900-Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10100-Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10300-Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14900-Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '22100-Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25700-Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '29400-Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36400-Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '44600-Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55600-Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '57600-Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '59700-Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '81900-Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '87900-Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33900-Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37200-General disorders and administration site conditions - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '60600-Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '12000-Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13100-Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20500-Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '25600-Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '44800-Infections and infestations - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '53100-Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '61100-Pancreas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '74600-Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '75200-Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '76000-Small intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '82300-Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '83100-Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '88900-Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '13800-Aortic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '45700-Injury poisoning and procedural complications - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '47300-Intraoperative hepatobiliary injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '47700-Intraoperative renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '10900-Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '17400-Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '24100-Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '34000-Fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '37500-GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '52600-Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '53700-Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 49, 'numAffected': 21}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '58300-Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 56, 'numAffected': 27}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '65800-Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 59, 'numAffected': 28}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88200-Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88300-Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88500-White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 50, 'numAffected': 23}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '10700-Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13500-Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 48, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24700-Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41300-Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41400-Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41600-Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41700-Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41800-Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42600-Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42700-Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42900-Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43100-Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43200-Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43300-Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43500-Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '54900-Metabolism and nutrition disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '18200-Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37300-Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '60700-Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10500-Abducens nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '38800-Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '79100-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11400-Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13700-Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25400-Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11100-Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '39300-Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71100-Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '19300-Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '29700-Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43900-Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '64900-Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66400-Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '68700-Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69000-Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71500-Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '78100-Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '74700-Skin and subcutaneous tissue disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '79000-Surgical and medical procedures - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'CTCv4'}, {'term': '39100-Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42100-Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43600-Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'seriousEvents': [{'term': '39000-Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '74500-Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10300-Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14900-Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55600-Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24600-Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37200-General disorders and administration site conditions - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55700-Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '60600-Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '21600-Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40000-Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40400-Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40600-Hepatobiliary disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66500-Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '44800-Infections and infestations - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '53100-Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '10900-Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '17400-Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '45800-INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88200-Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88300-Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '10700-Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13500-Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41600-Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41800-Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42600-Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43100-Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43300-Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '72500-Reversible posterior leukoencephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43900-Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '65900-Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69000-Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71600-Respiratory thoracic and mediastinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43600-Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (131I-MIBG, Chemotherapy)', 'description': 'Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '92.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 weeks after course 5 of induction', 'description': 'Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG.'}, {'type': 'PRIMARY', 'title': 'Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (131I-MIBG, Chemotherapy)', 'description': 'Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '68.7', 'upperLimit': '90.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to day -6 of conditioning', 'description': 'Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning.'}, {'type': 'SECONDARY', 'title': 'Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (131I-MIBG, Chemotherapy)', 'description': 'Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 weeks after course 5 of induction', 'description': 'Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who received 131I-MIBG therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (131I-MIBG, Chemotherapy)', 'description': 'Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Treatment Slot Not Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Refusal by patient/parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Pts MIBG non-avid after enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'On other COG study w/tumor tx intent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Inadequate stem cell for transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Initiation other tx prior to completion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (131I-MIBG, Chemotherapy)', 'description': 'Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '2.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2010-08-03', 'resultsFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-29', 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131', 'timeFrame': 'Up to 6 weeks after course 5 of induction', 'description': 'Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.'}, {'measure': 'Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy', 'timeFrame': 'Up to day -6 of conditioning', 'description': 'Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG', 'timeFrame': 'Up to 6 weeks after course 5 of induction', 'description': 'Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ganglioneuroblastoma', 'Localized Resectable Neuroblastoma', 'Localized Unresectable Neuroblastoma', 'Regional Neuroblastoma', 'Stage 4 Neuroblastoma', 'Stage 4S Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '34028986', 'type': 'DERIVED', 'citation': "Weiss BD, Yanik G, Naranjo A, Zhang FF, Fitzgerald W, Shulkin BL, Parisi MT, Russell H, Grupp S, Pater L, Mattei P, Mosse Y, Lai HA, Jarzembowski JA, Shimada H, Villablanca JG, Giller R, Bagatell R, Park JR, Matthay KK. A safety and feasibility trial of 131 I-MIBG in newly diagnosed high-risk neuroblastoma: A Children's Oncology Group study. Pediatr Blood Cancer. 2021 Oct;68(10):e29117. doi: 10.1002/pbc.29117. Epub 2021 May 24."}]}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess the feasibility of treating high-risk neuroblastoma patients, age 365 days - 30 years, with a) an induction block of meta-iodobenzylguanidine labeled with iodine-131 (131I-MIBG \\[iobenguane I 131\\]) delivered after multi-agent chemotherapy, and b) post-induction busulfan/melphalan (Bu/Mel) consolidation therapy.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the tolerability of treating high-risk neuroblastoma patients, age 365 days - 30 years, with a) an induction block of 131I-MIBG therapy delivered after multi-agent chemotherapy, and b) the tolerability of receiving post-induction Bu/Mel consolidation therapy with autologous stem-cell rescue (ASCR), and local radiation therapy.\n\nTERTIARY OBJECTIVES:\n\nI. To assess the response rate after a regimen of induction chemotherapy and 131I-MIBG and after a consolidation regimen of Bu/Mel with ASCR and local radiation therapy.\n\nII. To describe the relationship of tumor norepinephrine transporter (hNET) expression with radioiodinated MIBG uptake, at diagnosis as well as with tumor response.\n\nIII. To assess the relative reliability of 123 I-MIBG and fludeoxyglucose F-18 (18FDG)-positron emission tomography (PET) imaging in assessment of tumor activity at diagnosis, and prior to surgical resection.\n\nIV. To compare detectable tumor burden on the pre-surgical resection radioiodinated-MIBG diagnostic scan and the immediate post-MIBG therapy 131I-MIBG scan.\n\nV. To test for the relationship of occurrence of sinusoidal obstruction syndrome (SOS) to Bu/Mel or to whole-body radiation dose or delayed radiation clearance due to 131I-MIBG.\n\nVI. To analyze busulfan pharmacokinetics as measured by area under the curve (AUC) and relate exposure to SOS incidence.\n\nOUTLINE:\n\nINDUCTION CHEMOTHERAPY: Patients receive 5 courses of induction therapy.\n\nCourses 1-2: Patients receive cyclophosphamide intravenously (IV) over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5. Patients undergo peripheral blood stem cell (PBSC) collection after course 2.\n\nCourse 3 and 5: Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide phosphate IV over 1-2 hours on days 1-3. Patients undergo surgery to remove remaining tumor following course 5.\n\nCourse 4: Patients receive cyclophosphamide IV over 1-6 hours on days 1-2 and vincristine sulfate IV over 1 minute and doxorubicin hydrochloride IV over 24 hours on days 1-3.\n\nTreatment repeats every 21 days for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Patients without progressive disease proceed to iobenguane I 131 induction therapy beginning 3-6 weeks after course 5. Patients receive iobenguane I 131 IV over 90-120 minutes on day 1.\n\nSURGERY: Patients undergo surgery after course 4 or before consolidation therapy.\n\nCONSOLIDATION THERAPY: Within 10-12 weeks from the date of iobenguane I 131 infusion, patients receive busulfan IV over 2 hours every 6 hours on days -6 to -3 and melphalan IV on day -1.\n\nAUTOLOGOUS STEM CELL RESCUE: Patients undergo infusion of PBSC on day 0.\n\nRADIOTHERAPY: Beginning no sooner than 42 days after peripheral blood stem cell infusion, patients undergo 12 fractions of external-beam radiotherapy (2 dimensional \\[D\\], 3D-conformal, or intensity-modulated) to all areas of residual disease, primary tumor site, and involved nodal disease.\n\nMAINTENANCE THERAPY: Beginning 66 days after transplantation, patients receive isotretinoin orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 28 days for 6 courses.\n\nAfter completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have a diagnosis of neuroblastoma (International Classification of Diseases for Oncology \\[ICD-O\\] morphology 9500/3) or ganglioneuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:\n\n * Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 are eligible with the following:\n\n * v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) amplification (\\> 4-fold increase in MYCN signals as compared to reference signals) and age \\>= 365 days regardless of additional biologic features\n * Age \\> 18 months (\\> 547 days) regardless of biologic features\n * Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or deoxyribonucleic acid \\[DNA\\] index = 1) or any biologic feature that is indeterminant/unsatisfactory/unknown\n * Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:\n\n * MYCN amplification (\\> 4-fold increase in MYCN signals as compared to reference signals), and age \\>= 365 days, regardless of additional biologic features\n * Age \\> 18 months (\\> 547 days) with unfavorable pathology, regardless of MYCN status\n * Patients with newly diagnosed INSS stage 2a/2b with MYCN amplification (\\> 4-fold increase in MYCN signals as compared to reference signals) and age \\>= 365 days, regardless of additional biologic features\n * Patients \\>= 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy; these patients must have been enrolled on ANBL00B1; it is to be noted that study enrollment must occur within 4 weeks of progression to stage 4 for INSS stage 1, 2, 4S\n* Patients must have had no prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per low- or intermediate-risk neuroblastoma therapy (P9641, A3961, ANBL0531) prior to determination of MYCN amplification and histology\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL/min/1.73 m\\^2 OR serum creatinine based on age and/or gender as follows:\n\n * =\\< 0.6 mg/dL (1 to \\< 2 years of age)\n * =\\< 0.8 mg/dL (2 to \\< 6 years of age)\n * =\\< 1.0 mg/dL (6 to \\< 10 years of age)\n * =\\< 1.2 mg/dL (10 to \\< 13 years of age)\n * =\\< 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \\< 16 years of age)\n * =\\< 1.7 mg/dL (male) or 1.4 mg/dL (female) ( \\>= 16 years of age)\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) for age\n* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\< 10 x ULN for age\n* Shortening fraction \\>= 27% by echocardiogram or\n* Ejection fraction \\>= 50% by radionuclide evaluation\n* No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method\n* Female patients who are lactating must agree to stop breast-feeding\n* Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and DNA index \\> 1) are not eligible\n* Patients are not eligible if they have received local radiation which includes any of the following: 1200 centigray (cGy) to more than 33% of both kidneys (patient must have at least 1 kidney that has not exceeded the dose/volume of radiation listed) or 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver; emergency local irradiation is allowed prior to study entry, provided the patient still meets eligibility criteria'}, 'identificationModule': {'nctId': 'NCT01175356', 'briefTitle': 'Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma', 'orgStudyIdInfo': {'id': 'ANBL09P1'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01745', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ANBL09P1'}, {'id': 'CDR0000682629'}, {'id': 'ANBL09P1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ANBL09P1', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (131I-MIBG, chemotherapy)', 'description': 'See Detailed Description.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Procedure: Autologous Hematopoietic Stem Cell Transplantation', 'Drug: Busulfan', 'Drug: Cisplatin', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide Phosphate', 'Radiation: External Beam Radiation Therapy', 'Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation', 'Radiation: Intensity-Modulated Radiation Therapy', 'Radiation: Iobenguane I-131', 'Drug: Isotretinoin', 'Other: Laboratory Biomarker Analysis', 'Drug: Melphalan', 'Other: Pharmacological Study', 'Other: Questionnaire Administration', 'Procedure: Therapeutic Conventional Surgery', 'Drug: Topotecan Hydrochloride', 'Drug: Vincristine Sulfate']}], 'interventions': [{'name': '3-Dimensional Conformal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['3-dimensional radiation therapy', '3D Conformal', '3D CONFORMAL RADIATION THERAPY', '3D CRT', '3D radiotherapy', '3D-CRT', 'Conformal Therapy', 'Radiation Conformal Therapy', 'Radiation, 3D Conformal', 'Three dimensional external beam radiation therapy (procedure)'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Autologous Hematopoietic Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['AHSCT', 'Autologous', 'Autologous Hematopoietic Cell Transplantation', 'Autologous Stem Cell Transplant', 'Autologous Stem Cell Transplantation', 'Stem Cell Transplantation, Autologous'], 'description': 'Undergo autologous in vitro-treated peripheral blood stem cell transplantation', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Busulfan', 'type': 'DRUG', 'otherNames': ['1, 4-Bis[methanesulfonoxy]butane', 'BUS', 'Busilvex', 'Bussulfam', 'Busulfanum', 'Busulfex', 'Busulphan', 'CB 2041', 'CB-2041', 'Glyzophrol', 'GT 41', 'GT-41', 'Joacamine', 'Methanesulfonic Acid Tetramethylene Ester', 'Methanesulfonic acid, tetramethylene ester', 'Mielucin', 'Misulban', 'Misulfan', 'Mitosan', 'Myeleukon', 'Myeloleukon', 'Myelosan', 'Mylecytan', 'Myleran', 'Sulfabutin', 'Tetramethylene Bis(methanesulfonate)', 'Tetramethylene bis[methanesulfonate]', 'WR-19508'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Asta B 518', 'B 518', 'B-518', 'B518', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR 138719', 'WR- 138719', 'WR-138719', 'WR138719'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'FI106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Etoposide Phosphate', 'type': 'DRUG', 'otherNames': ['Etopophos'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'External Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam Radiation', 'External Beam Radiotherapy', 'External Beam Radiotherapy (conventional)', 'External Beam RT', 'external radiation', 'External Radiation Therapy', 'external-beam radiation', 'Radiation, External Beam', 'Teleradiotherapy', 'Teletherapy', 'Teletherapy Radiation'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'In Vitro-Treated Peripheral Blood Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['in vitro-treated PBPC transplantation', 'in vitro-treated peripheral blood progenitor cell transplantation'], 'description': 'Undergo autologous in vitro-treated peripheral blood stem cell transplantation', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Intensity-Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT', 'Intensity modulated radiation therapy (procedure)', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy', 'Radiation, Intensity-Modulated Radiotherapy'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Iobenguane I-131', 'type': 'RADIATION', 'otherNames': ['(131)I-MIBG', '131I-MIBG', 'I 131 Meta-iodobenzylguanidine', 'I-131 Metaiodobenzylguanidine', 'Iobenguane (131I)', 'Iobenguane I 131', 'Iodine I 131 Metaiodobenzylguanidine', 'MIBG I-131', 'Raiatt MIBG-I 131'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Isotretinoin', 'type': 'DRUG', 'otherNames': ['13-cis retinoic acid', '13-cis-Retinoate', '13-cis-Retinoic Acid', '13-cis-Vitamin A Acid', '13-cRA', 'Absorica', 'Accure', 'Accutane', 'Amnesteem', 'cis-Retinoic Acid', 'Cistane', 'Claravis', 'Isotretinoinum', 'Isotrex', 'Isotrexin', 'Myorisan', 'Neovitamin A', 'Neovitamin A Acid', 'Oratane', 'Retinoicacid-13-cis', 'Ro 4-3780', 'Ro-4-3780', 'Roaccutan', 'Roaccutane', 'Roacutan', 'Sotret', 'ZENATANE'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Alanine Nitrogen Mustard', 'CB-3025', 'L-PAM', 'L-Phenylalanine Mustard', 'L-Sarcolysin', 'L-Sarcolysin Phenylalanine mustard', 'L-Sarcolysine', 'Melphalan for Injection-Hepatic Delivery System', 'Melphalanum', 'Phenylalanine Mustard', 'Phenylalanine Nitrogen Mustard', 'Sarcoclorin', 'Sarkolysin', 'WR-19813'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgery', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Topotecan Hydrochloride', 'type': 'DRUG', 'otherNames': ['Evotopin', 'Hycamptamine', 'Hycamtin', 'Nogitecan Hydrochloride', 'Potactasol', 'SKF S 104864 A', 'SKF S-104864-A', 'SKF S104864A', 'Topotec', 'Topotecan HCl', 'topotecan hydrochloride (oral)'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine Sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (131I-MIBG, chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Arthur M Blank Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern/Simmons Cancer Center-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "Providence Sacred Heart Medical Center and Children's Hospital", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center - University Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Brian D Weiss', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}