Clinical Trial COGAALL06N1
Title
AALL06N1, A Study of Neurocognitive Function in Children Treated for ALL
Principal Investigator(s)
Details
- Protocol No. COGAALL06N1
- Open Date: 08/16/2007
- Staging: NA
- Age Group: Children
- Scope: National
- Objective: To determine outcomes in neuropsychological function among children treated with either, highdose methotrexate (5 g/m2) or escalating dose, Capizzi methotrexate in the absence of cranial radiation and/or Nelarabine. Identify host polymorphisms that may predict who, among the treated population, are at increased risk for neurocognitive dysfunction (primary) or acute neurotoxicity (secondary).
- Disease Sites: Pediatrics; Leukemia
- Therapies: Correlative
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT00437060
- Secondary Protocol No: AALL06N1
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 1 Year to 17 Years |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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