View Clinical Trial (Medical Research Study)
A Study of Neurocognitive Function in Children Treated for ALL
| City: |
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Fort Myers |
| State: |
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Florida |
| Zip Code: |
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33901 |
| Conditions: |
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Cognitive/Functional Effects - Leukemia - Long-term Effects Secondary to Cancer Therapy in Children - Neurotoxicity - Psychosocial Effects of Cancer and Its Treatment |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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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| NCT ID: |
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NCT00437060 |
| Primary Contact: |
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Study Chair
Naomi J. Winick, MD
Simmons Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Fort Myers, Florida 33901
United States
Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt
Phone: 877-680-0008
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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