Glioma (High-Grade and DIPG) Therapy with Selinexor and Radiation – Phase I/II

ACNS1821: A Study of the Drug Selinexor with Radiation Therapy in Patients with Newly Diagnosed DIPG and High-Grade Glioma

Protocol Description

This multi-center study organized by the Children’s Oncology Group is designed to find the best dose of selinexor that can safely be given with radiation therapy, and to determine what beneficial and side effects selinexor has on young people with a high-grade glioma or diffuse intrinsic pontine glioma (DIPG).

Study Level: I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 through 21 diagnosed with either high-grade glioma or DIPG.
Males and Females: Ages 1 through 21 years

Requirements

The protocol for this study begins with 8 weeks of chemoradiotherapy, entailing radiation treatments with an oral dose of selinexor given once each week. This will be followed by a 2-week rest period, after which up to 24 cycles of maintenance chemotherapy will begin. Each cycle of maintenance chemotherapy consists of taking selinexor orally once a week for 4 weeks.
Visits: Number of visits will vary based on participant response to protocol.
Duration: The treatment on this study takes a little over 2 years in most cases.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS1821)
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