Glioma (Low-Grade) Treatment using Selumetinib versus Standard Chemotherapy – Phase III

ACNS1833: A Study of the Drugs Selumetinib vs. Carboplatin/Vincristine in Patients with Low-Grade Glioma

Protocol Description

The goal of this multi-center study of the Children’s Oncology Group is to determine if a drug called selumetinib works as well as the standard treatment and with fewer side effects for young people with a low-grade glioma. Selumetinib is a drug that works by blocking a protein that lets cancer cells grow without stopping.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 2 through 21 years diagnosed with a low-grade glioma.
Males and Females: Ages 2 through 21 years

Requirements

Participants will be randomly selected to receive therapy with selumetinib taken orally as a capsule or the standard treatment, which uses a combination of the drugs carboplatin and vincristine given intravenously. Therapy with selumetinib takes about 27 months to complete and the standard therapy takes about 15 months to complete for most participants.
Visits: Number of visits will vary based on study arm and the participant’s response to protocol.
Duration: In addition to the treatment phase, participants will complete research tests for about 5 years after they enter this study.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS1833)
National Cancer Institute

Primary Investigator

James Felker, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Neuro-Oncology team, at:
chphoneuro-onc@upmc.edu