A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: I/II (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05099003?term=NCT05099003&rank=1
Summary
I. To define toxicities and estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of
selinexor administered as an oral formulation in combination with standard of care radiation therapy (RT), to
pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).
(Dose-finding phase/phase I) II. To estimate the event-free survival (EFS) distribution for diffuse midline glioma, H3
K27M-mutant (DMG)/HGG patients and overall survival (OS) distribution for DIPG patients associated with selinexor
plus RT, followed by selinexor in patients with newly diagnosed HGG (H3 K27M mutant DMG or H3 K27-wild type
HGG) or DIPG, and to compare those outcomes to historical controls. (Efficacy phase/phase II)