Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-30 @ 7:24 PM
Study NCT ID:
NCT01497860
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2011-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ehwang@childrensnational.org', 'phone': '2024765046', 'title': 'Associate Professor', 'organization': "Children's National Medical Center"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adverse Events', 'description': 'Neutropenia - Grade 4 (n=2) Thrombocytopenia - Grade 4 (n=1) Anemia - Grade 3 (n=2) Weight Loss - grade 2 (n=1)', 'otherNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'weight loss', 'notes': 'weight loss \\>10%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinorelbine', 'description': 'IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.\n\nVinorelbine: IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '31.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.', 'description': 'IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.', 'unitOfMeasure': 'percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vinorelbine', 'description': 'Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vinorelbine', 'description': 'Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months. Patients recruited without incidence over a 2 year period.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '3.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2011-12-16', 'resultsFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-22', 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.', 'description': 'IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatric', 'children', 'glioma', 'low-grade', 'vinorelbine', 'recurrent', 'progressive'], 'conditions': ['Low-grade Glioma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink or slow the growth of pediatric low-grade gliomas that have either returned or are continuing to grow.\n\nVinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its therapeutic spectrum and decrease the neurotoxicity associated with related agents.', 'detailedDescription': 'Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments.\n\nVinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors.\n\nObjective: To test the efficacy of Vinorelbine in children with pediatric low-grade glioma that has returned or continues to grow.\n\nIn this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. The patients will then be followed for 60 months. Progression free survival is the primary outcome and defined as the none of the following: greater a 20% increase in the sun of the longest diameter of the target lesion, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: \\< 18 years\n* Tumor: Progressive or recurrent low grade glioma, WHO grade 1 or 2 who have failed at least one form of 'conventional' non-surgical therapy\n* Histologic confirmation is required with the exception of optic pathway and brain stem gliomas. Patients are not required to have a re-operation at time of recurrence.\n* Patients with disseminated disease are eligible.\n* Children with neuro-fibromatosis and optic pathway or brainstem tumors are eligible but must have definitive radiologic or clinical evidence of progression\n* Patients must have evidence of measureable disease\n* Performance status: Karnofsky or Lansky performance status of \\>50%\n* Organ Function:\n* Adequate bone marrow function (ANC\\>1000/mm3, platelet count of \\>75,000/mm3, and hemoglobin \\> 8gm/dL) prior to starting therapy. Hemoglobin may be supported by transfusion\n* Adequate liver function (SGPT/ALT\\<2.5 times ULN and bilirubin \\< 1.5 times ULN) prior to starting therapy\n* Prior therapy:\n* May have had treatment including surgery, chemotherapy, or radiotherapy for any number of relapses prior to enrollment\n* Patients must have received their last fraction of radiotherapy \\>12 weeks prior to starting therapy\n* Previous Vincristine or Vinblastine exposure is allowable.\n\nExclusion Criteria:\n\n* No other significant medical illness that in the investigators' opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy\n* Any other cancer (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.\n* Patients of childbearing potential must not be pregnant or breast-feeding (vinorelbine is a pregnancy category D, no data on excretion in breastmilk)\n* Patients of childbearing or fathering potential must practice adequate contraception"}, 'identificationModule': {'nctId': 'NCT01497860', 'briefTitle': 'Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas', 'organization': {'class': 'OTHER', 'fullName': "Children's National Research Institute"}, 'officialTitle': 'Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas', 'orgStudyIdInfo': {'id': 'CNMC-VRL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vinorelbine', 'description': 'IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.', 'interventionNames': ['Drug: Vinorelbine']}], 'interventions': [{'name': 'Vinorelbine', 'type': 'DRUG', 'otherNames': ['Navelbine'], 'description': 'IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.', 'armGroupLabels': ['Vinorelbine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Eugene Hwang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eugene Hwang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Pediatric Oncology', 'investigatorFullName': 'Eugene Hwang', 'investigatorAffiliation': "Children's National Research Institute"}}}}