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Suspended Phase 1Phase 2 Interventional

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 ID: NCT05099003

Public ClinicalTrials.gov record NCT05099003. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05099003
Recruitment status
Suspended
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
132 participants

Conditions and interventions

Interventions

Procedure · Radiation · Drug

Eligibility (public fields only)

Age range
12 Months to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2022 (Actual)
Primary completion
Jun 30, 2027 (Estimated)
Completion
Jun 30, 2027 (Estimated)
Last update posted
Oct 13, 2026

2022 – 2027

United States locations

U.S. sites
111
U.S. states
42
U.S. cities
96
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 —
Banner Children's at Desert Mesa Arizona 85202 —
Phoenix Childrens Hospital Phoenix Arizona 85016 —
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 —
Loma Linda University Medical Center Loma Linda California 92354 —
Miller Children's and Women's Hospital Long Beach Long Beach California 90806 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Valley Children's Hospital Madera California 93636 —
UCSF Benioff Children's Hospital Oakland Oakland California 94609 —
Kaiser Permanente-Oakland Oakland California 94611 —
Children's Hospital of Orange County Orange California 92868 —
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304 —
Rady Children's Hospital - San Diego San Diego California 92123 —
UCSF Medical Center-Mission Bay San Francisco California 94158 —
Children's Hospital Colorado Aurora Colorado 80045 —
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Yale University New Haven Connecticut 06520 —
Alfred I duPont Hospital for Children Wilmington Delaware 19803 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 —
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 —
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 —
Miami Cancer Institute Miami Florida 33176 —
Arnold Palmer Hospital for Children Orlando Florida 32806 —
Nemours Children's Hospital Orlando Florida 32827 —
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 —
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida 33607 —
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 —
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 —
Saint Luke's Cancer Institute - Boise Boise Idaho 83712 —
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637 —
OSF Children's Hospital of Illinois Peoria Illinois 61637 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Blank Children's Hospital Des Moines Iowa 50309 —
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 —
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 —
Norton Children's Hospital Louisville Kentucky 40202 —
Children's Hospital New Orleans New Orleans Louisiana 70118 —
Eastern Maine Medical Center Bangor Maine 04401 —
Maine Children's Cancer Program Scarborough Maine 04074 —
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
C S Mott Children's Hospital Ann Arbor Michigan 48109 —
Children's Hospital of Michigan Detroit Michigan 48201 —
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 —
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 —
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 —
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 —
Washington University School of Medicine St Louis Missouri 63110 —
Mercy Hospital Saint Louis St Louis Missouri 63141 —
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Morristown Medical Center Morristown New Jersey 07960 —
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey 08903 —
Newark Beth Israel Medical Center Newark New Jersey 07112 —
Saint Joseph's Regional Medical Center Paterson New Jersey 07503 —
Albany Medical Center Albany New York 12208 —
Roswell Park Cancer Institute Buffalo New York 14263 —
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040 —
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
State University of New York Upstate Medical University Syracuse New York 13210 —
Montefiore Medical Center - Moses Campus The Bronx New York 10467 —
Novant Health Presbyterian Medical Center Charlotte North Carolina 28204 —
East Carolina University Greenville North Carolina 27834 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
Sanford Broadway Medical Center Fargo North Dakota 58122 —
Children's Hospital Medical Center of Akron Akron Ohio 44308 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Dayton Children's Hospital Dayton Ohio 45404 —
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio 43606 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Legacy Emanuel Children's Hospital Portland Oregon 97227 —
Oregon Health and Science University Portland Oregon 97239 —
Geisinger Medical Center Danville Pennsylvania 17822 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Saint Christopher's Hospital for Children Philadelphia Pennsylvania 19134 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 —
Rhode Island Hospital Providence Rhode Island 02903 —
Prisma Health Richland Hospital Columbia South Carolina 29203 —
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605 —
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 —
East Tennessee Childrens Hospital Knoxville Tennessee 37916 —
Saint Jude Children's Research Hospital Memphis Tennessee 38105 —
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203 —
Dell Children's Medical Center of Central Texas Austin Texas 78723 —
Driscoll Children's Hospital Corpus Christi Texas 78411 —
Medical City Dallas Hospital Dallas Texas 75230 —
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 —
El Paso Children's Hospital El Paso Texas 79905 —
Cook Children's Medical Center Fort Worth Texas 76104 —
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030 —
UT MD Anderson Cancer Center Houston Texas 77030 —
Children's Hospital of San Antonio San Antonio Texas 78207 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 —
Scott and White Memorial Hospital Temple Texas 76508 —
Primary Children's Hospital Salt Lake City Utah 84113 —
University of Virginia Cancer Center Charlottesville Virginia 22908 —
Children's Hospital of The King's Daughters Norfolk Virginia 23507 —
Seattle Children's Hospital Seattle Washington 98105 —
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 —
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 —
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05099003, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05099003 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →