COG ACNS1821

Clinical Trial 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)
Trial Status Open to Enrollment
Start Date 05/31/2022
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Malignant Glioma
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. 
Eligibility Criteria

Eligible Patients

  • Patients must be >= 12 months and =< 18 years of age at the time of enrollment 
  • Patient must have localized, newly diagnosed high-grade glioma (HGG) without H3 K27M mutation, excluding metastatic disease
  • Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment
  • As of February 14, 2025, stratum DIPG and stratum DMG (with H3 K27M mutation) have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.

Please contact Legacy's Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | 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) | ClinicalTrials.gov
Principal Investigator Jason Glover, MD
Contact Name Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel
Contact Phone 503-276-9300
Contact Fax 503-276-9351
Contact E-Mail childcanc@LHS.ORG