Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-20 @ 12:45 PM
Study NCT ID:
NCT03061656
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D019797', 'term': '3-Iodobenzylguanidine'}, {'id': 'D013852', 'term': 'Thiotepa'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D007462', 'term': 'Iodobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006847', 'term': 'Hydrocarbons, Iodinated'}, {'id': 'D013721', 'term': 'Triethylenephosphoramide'}, {'id': 'D001388', 'term': 'Aziridines'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of event free survival', 'timeFrame': 'Up to 5 years', 'description': 'Event is defined as relapse, disease progression or treatment-related mortality.'}], 'secondaryOutcomes': [{'measure': 'Rate of treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Risk Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '28511709', 'type': 'DERIVED', 'citation': 'Lee JW, Lee S, Cho HW, Ma Y, Yoo KH, Sung KW, Koo HH, Cho EJ, Lee SK, Lim DH. Incorporation of high-dose 131I-metaiodobenzylguanidine treatment into tandem high-dose chemotherapy and autologous stem cell transplantation for high-risk neuroblastoma: results of the SMC NB-2009 study. J Hematol Oncol. 2017 May 16;10(1):108. doi: 10.1186/s13045-017-0477-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a single arm trial of tandem HDCT/ASCT will be carried out.', 'detailedDescription': 'Although the outcome of high-risk neuroblastoma has improved after the introduction of HDCT/ASCT, the outcome was still unsatisfactory with 30-40% of survival. We previously reported the results of a single arm prospective trial (SMC NB-2004 study) using tandem HDCT/auto-SCT for high-risk neuroblastoma. In the NB-2004 trial, total body irradiation (TBI) was incorporated in second transplantation. Survival rates were very encouraging; however, short- and long-term toxicities associated with tandem HDCT/auto-SCT, particularly TBI, were also very significant. For this reason, we designed a new prospective trial (SMC NB-2009 study), in which only TBI in the second HDCT/auto-SCT of NB-2004 study was substituted with high-dose 131I-MIBG treatment in order to reduce short- and long-term toxicities without jeopardizing survival rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with high-risk neuroblastoma\n\nExclusion Criteria:\n\n* Patients with progressive disease before high-dose chemotherapy\n* Patients whose parents want to stop or change the planned treatment\n* Patients with organ toxicities of NCI grade \\>2 before high-dose chemotherapy'}, 'identificationModule': {'nctId': 'NCT03061656', 'briefTitle': 'Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma', 'orgStudyIdInfo': {'id': '2011-10-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High risk neuroblastoma', 'description': '1. Conventional chemotherapy (9 cycles)\n2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy)\n3. Tandem HDCT/autoSCT\n\n * First HDCT (cyclophosphamide, etoposide, carboplatin)\n * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)\n4. Local radiotherapy\n5. Retinoic acid, interleukin-2', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Carboplatin', 'Drug: Etoposide', 'Radiation: 131I-MIBG', 'Drug: Thiotepa', 'Drug: Melphalan']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '1st HDCT', 'armGroupLabels': ['High risk neuroblastoma']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': '1st HDCT', 'armGroupLabels': ['High risk neuroblastoma']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '1st HDCT', 'armGroupLabels': ['High risk neuroblastoma']}, {'name': '131I-MIBG', 'type': 'RADIATION', 'description': '2nd HDCT', 'armGroupLabels': ['High risk neuroblastoma']}, {'name': 'Thiotepa', 'type': 'DRUG', 'description': '2nd HDCT', 'armGroupLabels': ['High risk neuroblastoma']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': '2nd HDCT', 'armGroupLabels': ['High risk neuroblastoma']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ki Woong Sung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Republic of Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}