Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
Recruitment status was Recruiting
RATIONALE: Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.
PURPOSE: This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia.
Long-term Effects Secondary to Cancer Therapy in Children
Psychosocial Effects of Cancer and Its Treatment
Genetic: microarray analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: cognitive assessment
Procedure: diffusion tensor imaging
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
|Official Title:||A Study of Neurocognitive Function in Children Treated for ALL|
- Full Scale IQ as assessed by standardized age-appropriate test of developmental or neurocognitive function
- Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity
- Cerebrospinal fluid biomarkers
- MRI diffusion-tensor imaging
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- 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.
- Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.
- Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients.
- 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.
- 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.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.