Overview

This trial is active, not recruiting.

Conditions b-cell childhood acute lymphoblastic leukemia, cognitive/functional effects, long-term effects secondary to cancer therapy in children, neurotoxicity, psychosocial effects of cancer and its treatment, t-cell childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
Treatments cognitive assessment, psychosocial assessment and care, diffusion tensor imaging, laboratory biomarker analysis, pharmacological study
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date January 2007
End date June 2015
Trial size 249 participants
Trial identifier NCT00437060, AALL06N1, CDR0000528920, NCI-2009-00315, U10CA098543

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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. Patients 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.
cognitive assessment
Ancillary studies
psychosocial assessment and care psychosocial assessment
Ancillary studies
diffusion tensor imaging
Correlative studies
laboratory biomarker analysis
Correlative studies
pharmacological study pharmacological studies
Correlative studies

Primary Outcomes

Measure
Change in neurocognitive function by the Pediatric Quality of Life (PedQL) battery, Full Scale Intelligence Quotient (FSIQ) score
time frame: From baseline to up to 24 months
Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity
time frame: Up to 24 months

Secondary Outcomes

Measure
Correlation between neuropsychological outcomes and acute neurotoxicity
time frame: Up to 24 months

Eligibility Criteria

Male or female participants from 1 year up to 17 years old.

Inclusion Criteria: - Diagnosis of acute lymphoblastic leukemia - Enrolled on COG-AALL0434 (Cohort #1 only) or COG-AALL0232 (Cohorts #1 and #2) - Patients must have received either high-dose methotrexate or escalating-dose methotrexate during interim maintenance. - No CNS-3 disease - Patients must enroll within 8-24 months after completion of therapy on COG-AALL0232 and no evidence of relapsed or secondary malignancy - No known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following: - Down syndrome - Fragile X mental retardation - Autism - Pervasive developmental disability - Seizure disorder - Attention-deficit hyperactivity disorder or specific learning disability (e.g., dyslexia) allowed - No sensory impairment (e.g., pre-existing uncorrectable vision impairment or deafness) - No cranial radiation therapy

Additional Information

Official title A Study of Neurocognitive Function in Children Treated for ALL
Principal investigator Naomi Winick, MD
Description OBJECTIVES: I. 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. II. Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients. III. Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients. IV. 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. V. 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. OUTLINE: This is a prospective, cohort, multicenter study. 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. Patients 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. NOTE: * Within 8 months to 24 months after the completion of study therapy for patients on AALL0232.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Children's Oncology Group.