Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 8:48 AM
Study NCT ID:
NCT00437060
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2007-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}, {'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood and cerebrospinal fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2007-02-15', 'studyFirstSubmitQcDate': '2007-02-15', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neurocognitive function by the Pediatric Quality of Life (PedQL) battery, Full Scale Intelligence Quotient (FSIQ) score', 'timeFrame': 'From baseline to up to 24 months', 'description': 'Vocabulary and Block Design, subtests of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III), Wechsler Children Intelligence Scale (WISC-IV) and Wechsler Adult Intelligence Scale (WAIS-III) (based on age) will be used to estimate FSIQ, using the tables provided by Sattler.'}, {'measure': 'Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity', 'timeFrame': 'Up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Correlation between neuropsychological outcomes and acute neurotoxicity', 'timeFrame': 'Up to 24 months'}]}, 'conditionsModule': {'conditions': ['Childhood B Acute Lymphoblastic Leukemia', 'Childhood T Acute Lymphoblastic Leukemia', 'Cognitive Side Effects of Cancer Therapy', 'Long-Term Effects Secondary to Cancer Therapy in Children', 'Neurotoxicity Syndrome', 'Psychological Impact of Cancer', 'Untreated Childhood Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.', 'detailedDescription': 'OBJECTIVES:\n\nI. Determine the neuropsychological function in children with acute lymphoblastic leukemia treated with either high-dose methotrexate or escalating-dose methotrexate in the absence of cranial radiation and nelarabine.\n\nII. Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.\n\nIII. Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients.\n\nIV. Measure concentrations of 5-methyltetrahydrofolate, homocysteine, Ado, S-adenosylmethionine, S-adenosylhomocysteine, and other potentially relevant compounds in serum and cerebrospinal fluid during interim maintenance therapy with low- or high-dose methotrexate regimens, respectively, and correlate these endpoints with the occurrence of acute neurologic toxicity and long-term neurocognitive dysfunction in these patients.\n\nV. Determine whether or not diffusion tensor imaging will identify areas of selective vulnerability in CNS and provide an imaging modality that predicts and/or correlates with neuropsychological outcome.\n\nOUTLINE: This is a prospective, cohort, multicenter study.\n\nPatients complete neurocognitive tests to assess thinking, memory, attention, and concentration. The baseline test is administered during the consolidation phase of chemotherapy and further tests are done at 1 year from baseline and 1 year after\\* the completion of study therapy.\n\nPatients undergo blood and cerebrospinal fluid collection periodically for biomarker, genotypic polymorphisms, and pharmacokinetic analysis. Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological outcomes.\n\nNOTE: \\* Within 8 months to 24 months after the completion of study therapy for patients on AALL0232.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed acute lymphoblastic leukemia meeting other criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute lymphoblastic leukemia\n* Enrolled on COG-AALL0434 (Cohort #1 only) or COG-AALL0232 (Cohorts #1 and #2)\n\n * Patients must have received either high-dose methotrexate or escalating-dose methotrexate during interim maintenance.\n* No CNS-3 disease\n* Patients must enroll within 8-24 months after completion of therapy on COG-AALL0232 and no evidence of relapsed or secondary malignancy\n* No known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following:\n\n * Down syndrome\n * Fragile X mental retardation\n * Autism\n * Pervasive developmental disability\n * Seizure disorder\n* Attention-deficit hyperactivity disorder or specific learning disability (e.g., dyslexia) allowed\n* No sensory impairment (e.g., pre-existing uncorrectable vision impairment or deafness)\n* No cranial radiation therapy'}, 'identificationModule': {'nctId': 'NCT00437060', 'briefTitle': 'Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Study of Neurocognitive Function in Children Treated for ALL', 'orgStudyIdInfo': {'id': 'AALL06N1'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00315', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000528920'}, {'id': 'AALL06N1', 'type': 'OTHER', 'domain': 'Childrens Oncology Group'}, {'id': 'AALL06N1', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary/Correlative (neurocognitive assessment, biomarkers))', 'description': 'Patients complete neurocognitive tests to assess thinking, memory, attention, and concentration. The baseline test is administered during the consolidation phase of chemotherapy and further tests are done at 1 year from baseline and 1 year after\\* the completion of study therapy.\n\nPatients undergo blood and cerebrospinal fluid collection periodically for biomarker, genotypic polymorphisms, and pharmacokinetic analysis. Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological outcomes.', 'interventionNames': ['Procedure: Cognitive Assessment', 'Procedure: Diffusion Tensor Imaging', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Procedure: Psychosocial Assessment and Care']}], 'interventions': [{'name': 'Cognitive Assessment', 'type': 'PROCEDURE', 'description': 'Ancillary studies', 'armGroupLabels': ['Ancillary/Correlative (neurocognitive assessment, biomarkers))']}, {'name': 'Diffusion Tensor Imaging', 'type': 'PROCEDURE', 'otherNames': ['DTI'], 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary/Correlative (neurocognitive assessment, biomarkers))']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary/Correlative (neurocognitive assessment, biomarkers))']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary/Correlative (neurocognitive assessment, biomarkers))']}, {'name': 'Psychosocial Assessment and Care', 'type': 'PROCEDURE', 'otherNames': ['Psychosocial Assessment', 'Psychosocial Care', 'Psychosocial Care/Assessment', 'Psychosocial Studies', 'Psychosocial Support'], 'description': 'Ancillary studies', 'armGroupLabels': ['Ancillary/Correlative (neurocognitive assessment, biomarkers))']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 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