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NCT00437060 · CITED IN SOURCE DOCUMENTS

Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2017-07-21

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 help doctors plan cancer treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
17 Years
minimum Age
1 Year
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. CHILD
study Population
Patients with newly diagnosed acute lymphoblastic leukemia meeting other criteria.
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: Cognitive Assessment
    2. Procedure: Diffusion Tensor Imaging
    3. Other: Laboratory Biomarker Analysis
    4. Other: Pharmacological Study
    5. Procedure: Psychosocial Assessment and Care
    label
    Ancillary/Correlative (neurocognitive assessment, biomarkers))
interventions
  1. arm Group Labels
    1. Ancillary/Correlative (neurocognitive assessment, biomarkers))
    description
    Ancillary studies
    name
    Cognitive Assessment
    type
    PROCEDURE
  2. arm Group Labels
    1. Ancillary/Correlative (neurocognitive assessment, biomarkers))
    description
    Correlative studies
    name
    Diffusion Tensor Imaging
    other Names
    1. DTI
    type
    PROCEDURE
  3. arm Group Labels
    1. Ancillary/Correlative (neurocognitive assessment, biomarkers))
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  4. arm Group Labels
    1. Ancillary/Correlative (neurocognitive assessment, biomarkers))
    description
    Correlative studies
    name
    Pharmacological Study
    type
    OTHER
  5. arm Group Labels
    1. Ancillary/Correlative (neurocognitive assessment, biomarkers))
    description
    Ancillary studies
    name
    Psychosocial Assessment and Care
    other Names
    1. Psychosocial Assessment
    2. Psychosocial Care
    3. Psychosocial Care/Assessment
    4. Psychosocial Studies
    5. Psychosocial Support
    type
    PROCEDURE
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
233
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Vocabulary and Block Design, subtests of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III), Wechsler Children Intelligence Scale (WISC-IV) and Wechsler Adult Intelligence Scale (WAIS-III) (based on age) will be used to estimate FSIQ, using the tables provided by Sattler.
    measure
    Change in neurocognitive function by the Pediatric Quality of Life (PedQL) battery, Full Scale Intelligence Quotient (FSIQ) score
    time Frame
    From baseline to up to 24 months
  2. measure
    Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity
    time Frame
    Up to 24 months
secondary Outcomes
  1. measure
    Correlation between neuropsychological outcomes and acute neurotoxicity
    time Frame
    Up to 24 months
Full study description
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 help doctors plan cancer treatment.
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 cranial radiation and nelarabine. II. Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients. III. Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients. IV. 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. V. 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.
Source references
Source notices and limitations
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        ent neurocognitive testing, and their trajectories over time, were not evaluated in this study. </li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT00437060">AALL06N1 (NCT00437060)</a> trial, patients with high-risk B-ALL who had been enrolled in the AALL0232 trial received a neurocognitive evaluation. These patien
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        ing, and their trajectories over time, were not evaluated in this study. </li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT00437060">AALL06N1 (NCT00437060)</a> trial, patients with high-risk B-ALL who had been enrolled in the AALL0232 trial received a neurocognitive evaluation. These patients had been randomly as
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      source retrieved at
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      source title
      Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice