Status:
COMPLETED
Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood B Acute Lymphoblastic Leukemia
Childhood T Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-17 years
Brief Summary
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 h...
Detailed Description
OBJECTIVES: I. Determine the neuropsychological function in children with acute lymphoblastic leukemia treated with either high-dose methotrexate or escalating-dose methotrexate in the absence of cra...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00437060
Start Date
January 1 2007
Last Update
July 21 2017
Active Locations (112)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Southern California Permanente Medical Group
Downey, California, United States, 90242
4
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806