Neurotoxicity Clinical Trial
Official title:
Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve
the ability to plan treatment and decrease side effects.
PURPOSE: Clinical trial to compare brain function of children who have been previously
treated with methotrexate.
OBJECTIVES:
- Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in
children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess
intelligence, memory, learning, attention, concentration, processing of information,
functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be
accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605
will be accrued for this study.
;
Observational Model: Cohort, Time Perspective: Retrospective
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