NCT00028509

Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201

Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 9 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects. PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.

Detailed description

OBJECTIVES: * Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201. OUTLINE: This is a multicenter study. More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head. PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.

Conditions

• Long-term Effects Secondary to Cancer Therapy in Children
• Neurotoxicity

Interventions

Type	Name	Description
PROCEDURE	management of therapy complications

Timeline

• Start date: 2002-07-01
• Primary completion: 2011-07-01
• First posted: 2003-01-27
• Last updated: 2014-02-13

Locations

26 sites across 2 countries: United States, Canada