Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 1:11 AM
Study NCT ID:
NCT00389766
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
2006-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D019797', 'term': '3-Iodobenzylguanidine'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007462', 'term': 'Iodobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D006847', 'term': 'Hydrocarbons, Iodinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'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': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn because protocol has been discontinued. It was never opened.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2006-10-18', 'studyFirstSubmitQcDate': '2006-10-18', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who respond to treatment (partial response and complete response at metastatic sites) as measured by metaiodobenzylguanidine scintigraphy and positron emission tomography and CT imaging'}, {'measure': 'Proportion of patients who are able to progress to potentially curative treatment with surgery and further systemic treatment'}, {'measure': 'Correlation of tumor dosimetry with response'}, {'measure': 'Time to tumor progression'}]}, 'conditionsModule': {'keywords': ['localized unresectable neuroblastoma', 'recurrent neuroblastoma', 'regional neuroblastoma', 'localized resectable neuroblastoma', 'disseminated neuroblastoma'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG), releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Topotecan may also make tumor cells more sensitive to iodine I 131 MIBG. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by iodine I 131 MIBG and topotecan. This may allow more iodine I 131 MIBG and topotecan to be given so that more tumor cells are killed.\n\nPURPOSE: This phase II trial is studying how well giving high-dose iodine I 131 MIBG together with topotecan and peripheral stem cell transplant works in treating young patients with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine response (partial and complete response at metastatic sites) in children with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma treated with high-dose iodine I 131 metaiodobenzylguanidine, topotecan hydrochloride, and peripheral blood stem cell transplantation.\n* Determine the proportion of patients who, as a result of this treatment, are able to progress to potentially curative surgery and further systemic treatment.\n* Correlate tumor dosimetry (to determine whether the tumor absorbed the radiation dose) with response in patients treated with this regimen.\n* Determine the time to tumor progression.\n\nOUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease type (relapsed stage 4 vs primary resistant high-risk neuroblastoma).\n\nPatients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and 15-19 and high-dose iodine I 131 metaiodobenzylguanidine (\\^131I-MIBG) IV over 30 minutes on days 1 and 15. Patients receive autologous CD 34+ peripheral blood stem cells when \\^131I-MIBG dosimetry levels reach an acceptable low on days 25-29.\n\nTotal whole-body absorbed dose is measured periodically after the first \\^131I-MIBG dose is administered and periodically thereafter.\n\nAfter completion of study treatment, patients are followed periodically for up to 10 years.\n\nPROJECTED ACCRUAL: A total of 67 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:\n\n * Primary resistant high-risk disease meeting the following criteria:\n\n * International neuroblastoma staging system (INSS) stage 4, or stage 2 or 3 with myelocytomatosis viral-related oncogene (MycN) amplification\n * Failed to achieve satisfactory remission with induction chemotherapy, defined as one of the following:\n\n * Less than 50% reduction or \\> 3 positive sites on iodine I 131 metaiodobenzylguanidine (\\^131I-MIBG) scintigraphy\n * Persistent cytomorphological positive disease in bone marrow aspirates or trephine biopsies\n * Progressive disease necessitating a change of treatment\n * Relapsed stage 4 disease meeting the following criteria:\n\n * High-risk neuroblastoma (INSS stage 4, or stage 2 or 3 with MycN amplification)\n * Relapsed after intensive treatment including high-dose chemotherapy and hematopoietic progenitor cell support\n\n * Patients may be entered at the time of relapse, or at any point subsequently after other treatments\n* \\^131I-MIBG-positive disease on diagnostic scintigraphy\n* Peripheral blood stem cell harvest ≥ 300,000/mm³ CD 34+ cells\n* Enrolled in or has been treated on protocol SIOP-NB-2009 or a similar protocol\n\nPATIENT CHARACTERISTICS:\n\n* Glomerular filtration rate ≥ 50 mL/min\n* Considered fit enough to undergo proposed study treatment\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00389766', 'briefTitle': 'High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'International Phase II Studies of I-mIBG in Combination With Topotecan and Peripheral Blood Stem Cell Rescue for (A) Primary Resistant High Risk Neuroblastoma and (B) Relapsed Stage 4 Neuroblastoma', 'orgStudyIdInfo': {'id': 'CCLG-NB-2006-08'}, 'secondaryIdInfos': [{'id': 'CDR0000508611', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20644'}, {'id': 'EUDRACT-2005-002089-13'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'iodine I 131 metaiodobenzylguanidine', 'type': 'DRUG'}, {'name': 'topotecan hydrochloride', 'type': 'DRUG'}, {'name': 'chemotherapy', 'type': 'PROCEDURE'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'radioisotope therapy', 'type': 'PROCEDURE'}, {'name': 'radionuclide imaging', 'type': 'PROCEDURE'}, {'name': 'radiosensitization', 'type': 'PROCEDURE'}, {'name': 'total-body irradiation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark N. Gaze, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University College London Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer and Leukaemia Group", 'class': 'OTHER'}}}}