Glioma Treatment with Selumetinib (AZD6244) – Phase II

Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

Protocol Description

This Pediatric Brain Tumor Research Consortium trial is studying selumetinib, also known as AZD6244, in treating young patients with brain tumors. Researchers are studying the effects of varying dosage levels for patients ages 12 and up, and for patients under the age of 12. AZD6244 has been studied in adults, however it has not been previously studied in pediatric patients.
Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 3 to 21 years old, who have a brain tumor that is growing or has come back.
Males and Females: Ages 3 to 21 years

Requirements

Following an initial physical exam, participants will take a selumetinib capsule twice a day over a course of 28 days, for up to 26 courses. At specific intervals, researchers will require other tests, including bloodwork to measure how the study drug is being absorbed into the blood. MRI scans of the brain tumor will also be done after specific intervals.
Visits: 24
Duration: Approximately 2 years

Status: Open for Enrollment

Source(s) of Support

Pediatric Brain Tumor Consortium (Study PBTC-029B)
National Cancer Institute

Primary Investigator

A. Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864