Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT00437060


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.

Official Title

A Study of Neurocognitive Function in Children Treated for ALL

Stanford Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health


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


other: laboratory biomarker analysis

other: pharmacological study

procedure: cognitive assessment

procedure: diffusion tensor imaging

procedure: psychosocial assessment and care

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pediatric Hematology/Oncology

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