Glioma (Low-Grade) Treatment using Selumetinib with Vinblastine and Selumetinib Alone – Phase III

Protocol Description

This Children’s Oncology Group study compares the effects of a drug called selumetinib used in combination with vinblastine to using selumetinib alone in treating young people with a low-grade glioma (LGG) that is recurrent or progressive. Selumetinib is a drug that works by blocking a protein that lets cancer cells grow without stopping.

Study Level: III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 2 through 25 years diagnosed with a low-grade glioma that is progressive or recurrent. (For participants enrolled at age 22 and older, the diagnosis must have occurred by the age of 21.) Participants will have their LGG surgically removed prior to the chemotherapy given through this study.
Males and Females: Ages 2 through 25 years

Requirements

The study has two parts. In the first, participants will receive chemotherapy including selumetinib and vinblastine in 28-day cycles over the course of 17 months and then will receive selumetinib alone for another 10 cycles. Selumetinib is provided as a capsule taken orally twice a day, and vinblastine is given via intravenous infusion weekly. The aim of this part of the study is to determine the best dose of vinblastine. Those enrolled in the second part of the study will be randomly assigned to either receive selumetinib alone for 27 cycles of 28 days or the combination of selumetinib and the optimized dose of vinblastine for 17 cycles followed by 10 cycles of selumetinib alone.
Visits: Number of visits will vary based on the participant’s response to protocol.
Duration: About 27 months in most cases.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS1931)
National Cancer Institute

Additional Information

Study Description at the National Institutes of Health
Cancer and Blood Disorder Research 

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.