Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT00003234
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vinorelbine in Treating Children With Recurrent or Refractory Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'C531673', 'term': 'Familial ependymoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D005910', 'term': 'Glioma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-10-27', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent childhood rhabdomyosarcoma', 'recurrent neuroblastoma', 'recurrent childhood soft tissue sarcoma', 'recurrent childhood supratentorial primitive neuroectodermal tumor', 'recurrent childhood cerebellar astrocytoma', 'recurrent childhood cerebral astrocytoma', 'recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor', 'recurrent childhood ependymoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Neuroblastoma', 'Sarcoma']}, 'referencesModule': {'references': [{'pmid': '19533657', 'type': 'RESULT', 'citation': "Kuttesch JF Jr, Krailo MD, Madden T, Johansen M, Bleyer A; Children's Oncology Group. Phase II evaluation of intravenous vinorelbine (Navelbine) in recurrent or refractory pediatric malignancies: a Children's Oncology Group study. Pediatr Blood Cancer. 2009 Oct;53(4):590-3. doi: 10.1002/pbc.22133."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.\n\nOUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.\n\nPROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory solid malignant tumors of childhood including: Soft tissue sarcoma Rhabdomyosarcoma Nonrhabdomyosarcoma Extraosseous Ewing's sarcoma CNS tumors Astrocytoma Primitive neuroectodermal tumor Atypical teratoid/rhabdoid tumors Ependymoma Recurrent neuroblastoma Measurable disease No more than 2 prior treatment regimens\n\nPATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: For patients with solid tumors (unless marrow involvement): Absolute neutrophil count (ANC) at least 1000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) For patients post bone marrow transplantation: ANC at least 1,000/mm3 Platelet count at least 50,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) Hepatic: Total bilirubin no greater than 1.5 times normal SGOT/SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: Seizure disorder allowed if well controlled CNS toxicity no greater than grade 2\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior bone marrow transplantation No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for increased intracranial pressure due to CNS tumors Radiotherapy: At least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis Concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field Surgery: Not specified Other: No concurrent participation in another CCG, POG, or COG therapeutic study"}, 'identificationModule': {'nctId': 'NCT00003234', 'briefTitle': 'Vinorelbine in Treating Children With Recurrent or Refractory Cancers', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies', 'orgStudyIdInfo': {'id': 'A09705'}, 'secondaryIdInfos': [{'id': 'COG-A09705', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CCG-09705', 'type': 'OTHER', 'domain': "Children's Cancer Group"}, {'id': 'CDR0000066106', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratum 1 - Soft Tissue Sarcoma', 'description': 'See detailed description.', 'interventionNames': ['Drug: vinorelbine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 2 - CNS Tumors', 'description': 'See detailed description.', 'interventionNames': ['Drug: vinorelbine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 3 - Neuroblastoma', 'description': 'See detailed description.', 'interventionNames': ['Drug: vinorelbine tartrate']}], 'interventions': [{'name': 'vinorelbine tartrate', 'type': 'DRUG', 'otherNames': ['Navelbine®', "3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3,-dihydroxybutanedioate)"], 'armGroupLabels': ['Stratum 1 - Soft Tissue Sarcoma', 'Stratum 2 - CNS Tumors', 'Stratum 3 - Neuroblastoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive 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