Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cognitive/Functional Effects Leukemia Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Psychosocial Effects of Cancer and Its Treatment |
Genetic: microarray analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: pharmacological study Procedure: cognitive assessment Procedure: diffusion tensor imaging Procedure: management of therapy complications Procedure: psychosocial assessment and care |
| Study Type: | Observational |
| Official Title: | A Study of Neurocognitive Function in Children Treated for ALL |
- Full Scale IQ as assessed by standardized age-appropriate test of developmental or neurocognitive function
- Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity
- Cerebrospinal fluid biomarkers
- MRI diffusion-tensor imaging
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the neuropsychological function in children with acute lymphoblastic leukemia treated with either high-dose methotrexate or escalating-dose methotrexate in the absence of cranial radiation and nelarabine.
- Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.
- Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients.
- Measure concentrations of 5-methyltetrahydrofolate, homocysteine, Ado, S-adenosylmethionine, S-adenosylhomocysteine, and other potentially relevant compounds in serum and cerebrospinal fluid during interim maintenance therapy with low- or high-dose methotrexate regimens, respectively, and correlate these endpoints with the occurrence of acute neurologic toxicity and long-term neurocognitive dysfunction in these patients.
- Determine whether or not diffusion tensor imaging will identify areas of selective vulnerability in CNS and provide an imaging modality that predicts and/or correlates with neuropsychological outcome.
OUTLINE: This is a prospective, cohort, multicenter study.
Patients complete neurocognitive tests to assess thinking, memory, attention, and concentration. The baseline test is administered during the consolidation phase of chemotherapy and further tests are done at 1 year from baseline and 1 year after* the completion of study therapy.
Patients undergo blood and cerebrospinal fluid collection periodically for biomarker, genotypic polymorphisms, and pharmacokinetic analysis.
Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological outcomes.
NOTE: * Within 8 months to 24 months after the completion of study therapy for patients on AALL0232.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 95 Study Locations| Study Chair: | Naomi J. Winick, MD | Simmons Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00437060 History of Changes |
| Other Study ID Numbers: | CDR0000528920, COG-AALL06N1 |
| Study First Received: | February 15, 2007 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
neurotoxicity psychosocial effects of cancer and its treatment cognitive/functional effects long-term effects secondary to cancer therapy in children |
T-cell childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neurotoxicity Syndromes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on June 18, 2013