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Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
Not Recruiting
Trial ID: NCT00437060
Purpose
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
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Eligibility
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
Intervention(s):
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
650-723-5535