Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT00002458
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy in Treating Children With Metastatic Neuroblastoma in Second Remission
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': 'C000654310', 'term': 'humanized 3F8 anti-GD2 monoclonal antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1987-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2001-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-04', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-27', 'lastUpdatePostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['disseminated neuroblastoma', 'recurrent neuroblastoma'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.\n\nPURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating children with metastatic neuroblastoma in second remission.', 'detailedDescription': 'OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as adjuvant therapy in patients with Stage IV neuroblastoma in second remission.\n\nOUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal Antibody 3F8, MOAB 3F8.\n\nPROJECTED ACCRUAL: A maximum of 20 patients will be entered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites)\n\nPATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy: Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3 Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing deficit allowed\n\nPRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA titer is less than 1,000 U/mL serum by ELISA'}, 'identificationModule': {'nctId': 'NCT00002458', 'briefTitle': 'Monoclonal Antibody Therapy in Treating Children With Metastatic Neuroblastoma in Second Remission', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission', 'orgStudyIdInfo': {'id': '87-118'}, 'secondaryIdInfos': [{'id': 'CDR0000075103', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-V88-0357'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'monoclonal antibody 3F8', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nai-Kong V. Cheung, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}}}}