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

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Cancer Center Studies
1-866-574-5124

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