NCT00437060

Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

A Study of Neurocognitive Function in Children Treated for ALL

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 233 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood B Acute Lymphoblastic Leukemia
• Childhood T Acute Lymphoblastic Leukemia
• Cognitive Side Effects of Cancer Therapy
• Long-Term Effects Secondary to Cancer Therapy in Children
• Neurotoxicity Syndrome
• Psychological Impact of Cancer
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
PROCEDURE	Cognitive Assessment	Ancillary studies
PROCEDURE	Diffusion Tensor Imaging	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
PROCEDURE	Psychosocial Assessment and Care	Ancillary studies

Timeline

• Start date: 2007-01-01
• Primary completion: 2015-09-01
• First posted: 2007-02-19
• Last updated: 2017-07-21

Locations

112 sites across 4 countries: United States, Australia, Canada, New Zealand