Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT00365768
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2006-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D009396', 'term': 'Wilms Tumor'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jg589@cumc.columbia.edu', 'phone': '212-305-3379', 'title': 'Julia Glade-Bender, MD', 'organization': 'Columbia University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm I: Glutamine', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.\n\nGlutamine: Administered orally twice daily for 21 days', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.\n\nPlacebo: Administered orally twice daily for 21 days', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Vincristine-induced Peripheral Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Glutamine', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.\n\nGlutamine: Administered orally twice daily for 21 days'}, {'id': 'OG001', 'title': 'Arm II: Placebo', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.\n\nPlacebo: Administered orally twice daily for 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 weeks from baseline while on Vincristine treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression of Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Glutamine', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.\n\nGlutamine: Administered orally twice daily for 21 days'}, {'id': 'OG001', 'title': 'Arm II: Placebo', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.\n\nPlacebo: Administered orally twice daily for 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '42 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I: Glutamine', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.\n\nGlutamine: Administered orally twice daily for 21 days'}, {'id': 'FG001', 'title': 'Arm II: Placebo', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.\n\nPlacebo: Administered orally twice daily for 21 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All subjects were consented according to Institutional Review Board approved guidelines during out routine outpatient or inpatient stay. The period of recruitment was from January 2007 to July 2011.', 'preAssignmentDetails': 'Fifty-six patients were enrolled and 49 were evaluable, with the reasons for removal from study after randomization due to: change in clinical status (N=3), family withdrew (N=2), family relocation (N=1) and other (N=1). 49 patients were randomized to the glutamine or placebo arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I: Glutamine', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.\n\nGlutamine: Administered orally twice daily for 21 days'}, {'id': 'BG001', 'title': 'Arm II: Placebo', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.\n\nPlacebo: Administered orally twice daily for 21 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '19'}, {'value': '10', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '17'}, {'value': '11', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Fifty-six patients were enrolled and 49 were evaluable.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2006-08-16', 'resultsFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2006-08-16', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-25', 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Vincristine-induced Peripheral Neuropathy', 'timeFrame': 'Up to 30 weeks from baseline while on Vincristine treatment'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Progression of Neuropathy', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II childhood lymphoblastic lymphoma', 'stage III childhood lymphoblastic lymphoma', 'stage II childhood small noncleaved cell lymphoma', 'stage I Wilms tumor', 'stage II Wilms tumor', 'stage III Wilms tumor', 'stage IV Wilms tumor', 'stage V Wilms tumor', 'childhood grade III lymphomatoid granulomatosis', 'childhood diffuse large cell lymphoma', 'childhood immunoblastic large cell lymphoma', 'stage I childhood large cell lymphoma', 'stage I childhood lymphoblastic lymphoma', 'stage I childhood small noncleaved cell lymphoma', 'stage II childhood large cell lymphoma', 'stage III childhood large cell lymphoma', 'stage IV childhood large cell lymphoma', 'stage IV childhood lymphoblastic lymphoma', 'stage IV childhood small noncleaved cell lymphoma', 'childhood Burkitt lymphoma', 'stage III childhood small noncleaved cell lymphoma', 'untreated childhood acute lymphoblastic leukemia', 'childhood nasal type extranodal NK/T-cell lymphoma', 'previously untreated childhood rhabdomyosarcoma', 'localized Ewing sarcoma/PNET', 'metastatic Ewing sarcoma/PNET', 'neurotoxicity', 'peripheral neuropathy'], 'conditions': ['Kidney Cancer', 'Leukemia', 'Lymphoma', 'Neurotoxicity', 'Peripheral Neuropathy', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.\n\nPURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the incidence of vincristine-induced peripheral neuropathy in pediatric patients with lymphoma, leukemia, or solid tumors.\n\nSecondary\n\n* Compare the safety of glutamine vs placebo in these patients.\n* Compare the efficacy of glutamine vs placebo in reducing the progression and/or resolution of vincristine-induced peripheral neuropathy in these patients.\n* Compare the effect of glutamine supplementation vs placebo on chemotherapy-related toxicities in these patients.\n* Compare the effect of glutamine vs placebo on measures of quality of life in these patients.\n* Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor and glutamine levels in these patients.\n* Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.\n* Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.\n\nPatients in both arms undergo neuropsychological and clinical neurological assessment, blood collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and quality of life assessment on days 1, 21, and 42.\n\nAfter completion of study treatment, patients are followed for an additional 21 days.\n\nPROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the age of 5 and 21 years old.\n* Patients who demonstrate the ability to complete the assessment instruments at baseline.\n* Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of \\> or = to 6mg/m2 of vincristine, or \\> 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.\n\nExclusion Criteria:\n\n* Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.\n* Patients with recurrent disease.\n* Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.\n* Patients who have already received \\> 8mg/m2 of vincristine, or \\> 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.\n* Patients with hepatic encephalopathy or hyperammonemia.\n* Patients with a focally abnormal neurologic exam.'}, 'identificationModule': {'nctId': 'NCT00365768', 'briefTitle': 'Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer', 'orgStudyIdInfo': {'id': 'AAAA6806'}, 'secondaryIdInfos': [{'id': 'CPMC-ICCR-3349', 'type': 'OTHER', 'domain': 'Columbia University Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I: Glutamine', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.', 'interventionNames': ['Drug: Glutamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II: Placebo', 'description': 'Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Glutamine', 'type': 'DRUG', 'otherNames': ['Nutritional Supplement'], 'description': 'Administered orally twice daily for 21 days', 'armGroupLabels': ['Arm I: Glutamine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered orally twice daily for 21 days', 'armGroupLabels': ['Arm II: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Julia L. Glade-Bender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Irving Assistant Professor of Clinical Pediatrics', 'investigatorFullName': 'Julia Glade Bender', 'investigatorAffiliation': 'Columbia University'}}}}