Long-Term Effects Secondary to Cancer Therapy in Children Clinical Trial
Official title:
A Study of Neurocognitive Function in Children Treated for ALL
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.
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.
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