Glioma (High-Grade) Treatment with Dabrafenib and Trametnib After Irradiation – Phase II

ACNS1723: A Study of the Drugs Dabrafenib and Trametinib after Radiation Therapy in Patients with Newly Diagnosed High-Grade Glioma

Protocol Description

The overall goal of this multi-center study by the Children’s Oncology Group is to see if using the drugs dabrafenib and trametinib after radiation treatment is better than prior treatments in helping to eliminate or shrink high-grade gliomas in young people. Dabrafenib works by blocking a protein, called BRAF, that lets cancer cells grow without stopping. Trametinib works similarly by blocking the protein MEK, which allows cancer cells to grow without stopping.

Study Level: II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 through 21 years who have been newly diagnosed with a high-grade glioma with a BRAF V600 mutation.
Males and Females: Ages 1 through 21 years

Requirements

The treatment on this study is divided into 2 phases of therapy, which is done following surgery to remove the tumor. The first phase is radiation treatment, which lasts 6 to 7 weeks in most cases. After a 4-week rest period, the maintenance phase begins, with up to 24 cycles of chemotherapy using dabrafenib and trametinib provided in tablet, capsule, or liquid form. Each cycle lasts 28 days.
Visits: Number of visits will vary based on participant response to protocol.
Duration: A little more than 2 years in most cases.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS1723)
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