Brain Tumor Memory Study – Phase II

Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor

Protocol Description

This multicenter trial investigates how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor. Neurocognitive dysfunction (difficulty thinking and learning) affects nearly half of all childhood cancer survivors, especially children treated for a brain tumor. Modafinil is a stimulant medicine that has been studied in children with attention deficit disorder and excessive sleepiness, has shown good results for improving cognition, mood, and fatigue in adult breast cancer and brain tumor survivors.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 6 to 19 years, who have been treated for brain cancer by neurosurgical resection, cranial irradiation or chemotherapy. A screening process will determine whether candidates have experienced neurocognitive changes after treatment for cancer.
Males and Females: Ages 6 to 18 years

Requirements

Study participants will be randomly assigned to one of two groups. One will be given a placebo and the other will receive the study drug taken orally for 6 weeks. During the study, participants will be tested for attention, memory, and speed of cognitive processing. Clinic visits are required for screening and after 2 weeks and 6 weeks on the study medication, and telephone interviews will take place during the other weeks. The final visit or telephone contact will occur a month after the final dose is taken.
Visits: 3 or 4
Duration: 10 weeks

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACCL0922)
National Cancer Institute
SunCoast CCOP Research Base

Primary Investigator

Jean M. Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Jean M. Tersak, MD
412-692-5055