Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 7:41 AM
Study NCT ID:
NCT00002560
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced 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': 'C000654310', 'term': 'humanized 3F8 anti-GD2 monoclonal antibody'}, {'id': 'C081222', 'term': 'sargramostim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['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. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.\n\nPURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.\n* Assess the biological effects of 3F8/GM-CSF in these patients.\n\nOUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Neuroblastoma diagnosed by INSS criteria, i.e., either:\n\n * Histologic proof of disease OR\n * Tumor clumps in bone marrow plus elevated catecholamine levels\n* Relapsed disease with poor long-term prognosis as indicated by at least one of the following:\n\n * N-myc amplification in tumor cells\n * Diploid chromosomal content in tumor cells\n * Distant skeletal metastases\n * Unresectable primary tumor crossing the midline\n * Bone marrow with greater than 10% tumor cells\n* Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required\n* No rapidly progressive disease\n* Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 2 to 21\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Greater than 8 weeks\n\nHematologic:\n\n* Not specified\n\nHepatic:\n\n* No grade 3/4 toxicity\n* LDH no greater than 1.5 times upper limit of normal\n\nRenal:\n\n* Creatinine clearance at least 60 mL/min\n* No grade 3/4 toxicity\n\nCardiovascular:\n\n* No grade 3/4 toxicity\n\nPulmonary:\n\n* No grade 3/4 toxicity\n\nOther:\n\n* No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit\n* No active life threatening infections\n* No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL\n* No allergy to mouse proteins\n* No pain requiring opiates\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00002560', 'briefTitle': 'Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA', 'orgStudyIdInfo': {'id': '94-018'}, 'secondaryIdInfos': [{'id': 'CDR0000063466', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-V94-0416'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'monoclonal antibody 3F8', 'type': 'BIOLOGICAL'}, {'name': 'sargramostim', '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': 'Brian H. Kushner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}}}}