NCT05099003

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Recruiting now Phase 1, PHASE2 Last updated 14 April 2026

What this trial tests

Phase 1, PHASE2 trial testing Biopsy Procedure in Malignant Glioma in 132 participants. Currently enrolling.

Timeline

31 May 2022

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	132
Start date	31 May 2022
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	127 locations across New Zealand, Canada, United States, Australia

Drugs / interventions tested

• Biopsy Procedure
• Magnetic Resonance Imaging
• Radiation Therapy — full drug profile →
• Selinexor — full drug profile →

Conditions studied

• Malignant Glioma — all drugs for Malignant Glioma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 12 Months to 21, any sex, with Malignant Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pediatric Diffuse Midline Gliomas: An Unfinished Puzzle.
   Di Ruscio V, Del Baldo G, Fabozzi F, Vinci M, et al · · 2022 · cited 34× · PMID 36140466 · DOI 10.3390/diagnostics12092064
2. H3 K27M-altered glioma and diffuse intrinsic pontine glioma: Semi-systematic review of treatment landscape and future directions.
   van den Bent M, Saratsis AM, Geurts M, Franceschi E. · · 2024 · cited 25× · PMID 38102230 · DOI 10.1093/neuonc/noad220
3. Targeting diffuse midline gliomas: The promise of focused ultrasound-mediated blood-brain barrier opening.
   Martinez PJ, Green AL, Borden MA. · · 2024 · cited 24× · PMID 38000663 · DOI 10.1016/j.jconrel.2023.11.037
4. Therapeutic avenues for targeting treatment challenges of diffuse midline gliomas.
   Noon A, Galban S. · · 2023 · cited 22× · PMID 37030112 · DOI 10.1016/j.neo.2023.100899
5. Diffuse intrinsic pontine glioma (DIPG): A review of current and emerging treatment strategies.
   Weisbrod LJ, Thiraviyam A, Vengoji R, Shonka N, et al · · 2024 · cited 14× · PMID 38609002 · DOI 10.1016/j.canlet.2024.216876
6. Interdisciplinary care of children with diffuse midline glioma.
   Coleman C, Chen K, Lu A, Seashore E, et al · · 2023 · cited 14× · PMID 36410226 · DOI 10.1016/j.neo.2022.100851
7. Advances and Clinical Trials Update in the Treatment of Diffuse Intrinsic Pontine Gliomas.
   Dalle Ore C, Coleman C, Gupta N, Mueller S. · · 2023 · cited 12× · PMID 36642062 · DOI 10.1159/000529099
8. Emerging and Biological Concepts in Pediatric High-Grade Gliomas.
   Yoel A, Adjumain S, Liang Y, Daniel P, et al · · 2024 · cited 9× · PMID 39273062 · DOI 10.3390/cells13171492