A Phase I/II Study of Selinexor and Radiation Therapy for Newly Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma and High-Grade Glioma

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Full Title

A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG) (ACNS1821) (CIRB)

Purpose

The purpose of this study is to find the best dose of the drug selinexor that can be given safely with radiation therapy in young patients newly diagnosed with pediatric diffuse intrinsic pontine glioma (DIPG) or high-grade glioma. Researchers will also determine the effectiveness of combining selinexor with radiation therapy (given for eight weeks) followed by selinexor therapy alone for two years.

Selinexor blocks a protein called XPO1, which may help keep cancer cells from growing and may kill them. It is given orally (by mouth). Researchers believe that combining selinexor with radiation therapy may be effective for treating DIPG and high-grade glioma.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must be newly diagnosed with DIPG or high-grade glioma.
  • This study is for children, adolescents, and young adults ages 1-21 years.

Contact

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

22-381

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed

Investigator

ClinicalTrials.gov ID

NCT05099003