AALL06N1: A Study of Neurocognitive Function in Children Treated for ALL
Investigator: Julio Barredo
Institutional Protocol #: 20070556
National Clinical Trials Identifier: NCT00437060
Funding Agency/Sponsor: Children Oncology Group
Division: Cancer Center
Therapeutic Area: Pediatric Cancer
Phase: N/A
Enrolling Sites: Jackson Memorial Hospital
Enrolling Since: 11/27/2007
Purpose/Abstract:
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.
Eligibility Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia
- Enrolled on COG-AALL0434 or COG-AALL0232
- 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
PATIENT CHARACTERISTICS:
- 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)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No cranial radiation therapy
Gender: Both
Minimum Age: 1 Year
Maximum Age: 17 Years
Accepts healthy volunteers: No
Cancer Center Studies
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