Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00033293
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2002-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'New Zealand', 'Puerto Rico', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'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': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D019370', 'term': 'Observation'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C407664', 'term': 'deltacortene'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D005719', 'term': 'gamma-Globulins'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'C000617884', 'term': 'Panzyga'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}]}}, '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 Sponsor approval', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.\n\nPatients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).', 'otherNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nPatients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.', 'otherNumAtRisk': 27, 'otherNumAffected': 18, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}], 'otherEvents': [{'term': '13200-Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33300-Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '74200-Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11200-Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24200-Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '22100-Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25700-Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '31200-Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36700-Gastrointestinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '46300-Intra-abdominal hemorrhage(targeted toxicity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55600-Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '57600-Nausea(targeted toxicity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '87900-Vomiting(targeted toxicity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33900-Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '48700-Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '16800-Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '20500-Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '29500-Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '44800-Infections and infestations - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '82300-Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '83100-Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '34900-Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '53700-Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '58300-Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '65800-Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88200-Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88500-White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '13500-Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24700-Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41300-Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41400-Hyperglycemia(targeted toxicity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41600-Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42600-Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42700-Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42900-Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43100-Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43300-Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43500-Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '15300-Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58700-Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69300-Pyramidal tract syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11400-Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 25, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13700-Anxiety(targeted toxicity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '64400-Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43900-Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41500-Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69700-Rash maculo-papular(targeted toxicity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42100-Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'seriousEvents': [{'term': '53100-Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.\n\nPatients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nPatients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Chi-squared test statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.125', 'pValueComment': 'No adjustments for multiple comparisons.', 'groupDescription': 'The 5 categories of OMA ratings are: stance, gait, arm \\& hand function, opsoclonus, \\& mood/behavior. For each category, a patient\'s response will be based on a comparison of the baseline evaluation to the "best" of 3 time points: 2 months, 6 months \\& 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'A two-way test with a null hypothesis of no association, using SAS 9.4.'}], 'paramType': 'NUMBER', 'timeFrame': 'Changes from baseline to 2 months, 6 months, and 1 year', 'description': 'A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients'}, {'type': 'SECONDARY', 'title': 'Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Randomized to chemotherapy, immunoglobulin therapy.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Randomized to chemotherapy, observation'}], 'classes': [{'categories': [{'measurements': [{'value': '84.53', 'spread': '115.91', 'groupId': 'OG000'}, {'value': '144.73', 'spread': '110.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '60.1979', 'groupDescription': 'The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Changes from baseline to the better of 6 months or 1 year', 'description': 'The "best" score at the two time points will be used in this analysis. For a given patient, this "best" score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated.', 'unitOfMeasure': 'Change in VABS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.'}, {'type': 'SECONDARY', 'title': 'Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Randomized to chemotherapy, immunoglobulin therapy.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Randomized to chemotherapy, observation'}], 'classes': [{'categories': [{'measurements': [{'value': '117.5', 'spread': '35.35', 'groupId': 'OG000'}, {'value': '100.75', 'spread': '25.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2364', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '16.75', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.'}], 'paramType': 'MEAN', 'timeFrame': 'Changes from baseline to the better of 6 months or 1 year', 'description': 'The Bayley Scales of infant development mental scale "best" score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline.', 'unitOfMeasure': "Change in Bayley's score", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year."}, {'type': 'SECONDARY', 'title': 'Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Randomized to chemotherapy, immunoglobulin therapy.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Randomized to chemotherapy, observation'}], 'timeFrame': 'At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis', 'description': 'Descriptive analyses on biologic variables will be performed', 'reportingStatus': 'POSTED', 'populationDescription': "The necessary data will never be collected, therefore results can't be provided."}, {'type': 'SECONDARY', 'title': 'Long-term Prognosis for Neurologic Recovery by Neurological Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Randomized to chemotherapy, immunoglobulin therapy.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Randomized to chemotherapy, observation'}], 'timeFrame': 'At diagnosis and yearly for 10 years after diagnosis', 'description': 'A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.', 'reportingStatus': 'POSTED', 'populationDescription': "The necessary data will never be collected, therefore results can't be provided."}, {'type': 'SECONDARY', 'title': 'Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Randomized to chemotherapy, immunoglobulin therapy.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Randomized to chemotherapy, observation'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '81.8', 'upperLimit': '100'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '87.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'EFS rate for neuroblastoma event from time of study enrollment.', 'unitOfMeasure': '3 year EFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible randomized patients.'}, {'type': 'SECONDARY', 'title': 'Tumor Outcome in Terms of Overall Survival (OS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Randomized to chemotherapy, immunoglobulin therapy.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Randomized to chemotherapy, observation'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '87.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'OS rate from time of study enrollment.', 'unitOfMeasure': '3 year OS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible randomized patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.\n\nPatients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).'}, {'id': 'FG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nPatients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Could not be weaned from steroid therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Treatment refused', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Chemotherapy, Immunoglobulin Therapy)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.\n\nPatients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).'}, {'id': 'BG001', 'title': 'Arm II (Chemotherapy, Observation)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nPatients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2002-04-09', 'resultsFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-09', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responders', 'timeFrame': 'Changes from baseline to 2 months, 6 months, and 1 year', 'description': 'A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.'}], 'secondaryOutcomes': [{'measure': 'Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)', 'timeFrame': 'Changes from baseline to the better of 6 months or 1 year', 'description': 'The "best" score at the two time points will be used in this analysis. For a given patient, this "best" score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated.'}, {'measure': 'Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing', 'timeFrame': 'Changes from baseline to the better of 6 months or 1 year', 'description': 'The Bayley Scales of infant development mental scale "best" score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline.'}, {'measure': 'Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology', 'timeFrame': 'At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis', 'description': 'Descriptive analyses on biologic variables will be performed'}, {'measure': 'Long-term Prognosis for Neurologic Recovery by Neurological Examination', 'timeFrame': 'At diagnosis and yearly for 10 years after diagnosis', 'description': 'A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.'}, {'measure': 'Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death', 'timeFrame': 'Up to 3 years', 'description': 'EFS rate for neuroblastoma event from time of study enrollment.'}, {'measure': 'Tumor Outcome in Terms of Overall Survival (OS) Rate', 'timeFrame': 'Up to 3 years', 'description': 'OS rate from time of study enrollment.'}]}, 'conditionsModule': {'conditions': ['Localized Resectable Neuroblastoma', 'Localized Unresectable Neuroblastoma', 'Regional Neuroblastoma', 'Stage 4 Neuroblastoma', 'Stage 4S Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '29376112', 'type': 'DERIVED', 'citation': 'de Alarcon PA, Matthay KK, London WB, Naranjo A, Tenney SC, Panzer JA, Hogarty MD, Park JR, Maris JM, Cohn SL. Intravenous immunoglobulin with prednisone and risk-adapted chemotherapy for children with opsoclonus myoclonus ataxia syndrome associated with neuroblastoma (ANBL00P3): a randomised, open-label, phase 3 trial. Lancet Child Adolesc Health. 2018 Jan;2(1):25-34. doi: 10.1016/S2352-4642(17)30130-X. Epub 2017 Nov 3.'}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine whether cyclophosphamide and prednisone with or without immune globulin is a reasonable baseline standard therapy for pediatric patients with neuroblastoma-associated opsoclonus-myoclonus-ataxia (OMA) syndrome.\n\nII. Determine whether immunosuppressive therapy with cyclophosphamide and prednisone is an effective backbone therapy for OMA upon which to build additional treatment for these patients\n\nSECONDARY OBJECTIVES:\n\nI. Determine whether these regimens improve OMA syndrome in these patients. II. Determine whether these regimens improve motor coordination in these patients.\n\nIII. Determine these regimens improve functional outcome in these patients. IV. Investigate the biology of neuroblastoma associated OMA, with specific regard to magnetic resonance imaging (MRI) findings, anti-neuronal antibodies, cerebrospinal fluid (CSF) findings and tumor biology.\n\nVI. Define better the long-term prognosis for neurologic recovery in the child with neuroblastoma associated with OMA syndrome. VII. Compare the event-free and overall survival of patients treated with these regimens.\n\nOUTLINE:\n\nCHEMOTHERAPY: Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nIMMUNE GLOBULIN THERAPY: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive immune globulin IV on days -2 and -1, at weeks 4, 8, 12, 16, 20, and 24, and then at months 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment.\n\nARM II: Patients do not receive immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.\n\nPatients are followed during therapy every month for 6 months, at 1 year, and then annually for up to 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed neuroblastoma (NBL) or ganglioneuroblastoma with tumor-associated opsoclonus-myoclonus-ataxia syndrome (OMA)\n\n * Patients with NBL diagnosed within 6 months of OMA diagnosis AND patients with OMA diagnosed within 6 months of NBL diagnosis are eligible\n * Must enroll on study within 4 weeks of diagnosis\n * Presence of opsoclonus, myoclonus, and/or ataxia associated with neuroblastoma considered eligible\n* Currently enrolled on COG neuroblastoma protocols: COG-ANBL00B1 or its successor\n* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:\n\n * ≤ 0.4 mg/dL (for patients 1 to 5 months of age)\n * ≤ 0.5 mg/dL (for patients 6 to 11 months of age)\n * ≤ 0.6 mg/dL (for patients 1 year of age)\n * ≤ 0.8 mg/dL (for patients 2 to 5 years of age)\n * ≤ 1.0 mg/dL (for patients 6 to 9 years of age)\n * ≤ 1.2 mg/dL (for patients 10 to 12 years of age)\n * ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)\n * ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)\n * ≤ 1.6 mg/dL (for male patients ≥ 16 years of age)\n* No prior IV gamma globulin therapy\n* No prior chemotherapy\n* Concurrent chemotherapy allowed\n* No prior prednisone or corticotropin\n\n * Patients who have received ≤ 14 days of steroids are eligible\n* Concurrent surgery allowed'}, 'identificationModule': {'nctId': 'NCT00033293', 'briefTitle': 'Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone', 'orgStudyIdInfo': {'id': 'ANBL00P3'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00399', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-ANBL00P3'}, {'id': 'CDR0000069271'}, {'id': 'ANBL00P3', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ANBL00P3', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA013539', 'link': 'https://reporter.nih.gov/quickSearch/U10CA013539', 'type': 'NIH'}, {'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': 'Arm I (chemotherapy, immunoglobulin therapy)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nPatients receive immune globulin IV on days -2 and -1, at weeks 4, 8, 12, 16, 20, and 24, and then at months 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment.', 'interventionNames': ['Drug: Cyclophosphamide', 'Other: Laboratory Biomarker Analysis', 'Procedure: Magnetic Resonance Imaging', 'Drug: Prednisone', 'Biological: Therapeutic Immune Globulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (chemotherapy, observation)', 'description': 'Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.\n\nPatients do not receive immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.', 'interventionNames': ['Other: Clinical Observation', 'Drug: Cyclophosphamide', 'Other: Laboratory Biomarker Analysis', 'Procedure: Magnetic Resonance Imaging', 'Drug: Prednisone']}], 'interventions': [{'name': 'Clinical Observation', 'type': 'OTHER', 'otherNames': ['observation'], 'description': 'Undergo observation', 'armGroupLabels': ['Arm II (chemotherapy, observation)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 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'DRUG', 'otherNames': ['.delta.1-Cortisone', '1, 2-Dehydrocortisone', 'Adasone', 'Cortancyl', 'Dacortin', 'DeCortin', 'Decortisyl', 'Decorton', 'Delta 1-Cortisone', 'Delta-Dome', 'Deltacortene', 'Deltacortisone', 'Deltadehydrocortisone', 'Deltasone', 'Deltison', 'Deltra', 'Econosone', 'Lisacort', 'Meprosona-F', 'Metacortandracin', 'Meticorten', 'Ofisolona', 'Orasone', 'Panafcort', 'Panasol-S', 'Paracort', 'Perrigo Prednisone', 'PRED', 'Predicor', 'Predicorten', 'Prednicen-M', 'Prednicort', 'Prednidib', 'Prednilonga', 'Predniment', 'Prednisone Intensol', 'Prednisonum', 'Prednitone', 'Promifen', 'Rayos', 'Servisone', 'SK-Prednisone'], 'description': 'Given orally', 'armGroupLabels': ['Arm I (chemotherapy, immunoglobulin therapy)', 'Arm II (chemotherapy, observation)']}, {'name': 'Therapeutic Immune Globulin', 'type': 'BIOLOGICAL', 'otherNames': ['BayGam', 'Gamimune N', 'Gamma Globulin', 'Gammagard S/D', 'Gammar-P', 'IgIV', 'Immune Globulin', 'Immune Globulin Intravenous', 'Immune 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