A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
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.
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
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Interventions
- Biopsy Procedure Procedure
- Magnetic Resonance Imaging Procedure
- Radiation Therapy Radiation
- Selinexor Drug
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 30, 2022
- Primary completion
- Jun 29, 2027
- Completion
- Jun 29, 2027
- Last update posted
- Sep 3, 2026
2022 – 2027
United States locations
- U.S. sites
- 109
- U.S. states
- 42
- U.S. cities
- 94
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | Recruiting |
| Banner Children's at Desert | Mesa | Arizona | 85202 | Recruiting |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | Recruiting |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | Recruiting |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | Recruiting |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | Recruiting |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | Recruiting |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | Recruiting |
| Children's Hospital of Orange County | Orange | California | 92868 | Recruiting |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | Recruiting |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | Recruiting |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Recruiting |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | Recruiting |
| Yale University | New Haven | Connecticut | 06520 | Recruiting |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | Recruiting |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | Recruiting |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | Recruiting |
| Miami Cancer Institute | Miami | Florida | 33176 | Active, not recruiting |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | Recruiting |
| Nemours Children's Hospital | Orlando | Florida | 32827 | Recruiting |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | Recruiting |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | Recruiting |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | Recruiting |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | Recruiting |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| OSF Children's Hospital of Illinois | Peoria | Illinois | 61637 | Recruiting |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | Recruiting |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | Recruiting |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | Recruiting |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | Recruiting |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | Recruiting |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | Recruiting |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | Recruiting |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | Recruiting |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | Recruiting |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | Recruiting |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | Recruiting |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | Recruiting |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | Recruiting |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | Recruiting |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Recruiting |
| Morristown Medical Center | Morristown | New Jersey | 07960 | Recruiting |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | Recruiting |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | Recruiting |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | Recruiting |
| Albany Medical Center | Albany | New York | 12208 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | Suspended |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | Recruiting |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | Recruiting |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | Recruiting |
| East Carolina University | Greenville | North Carolina | 27834 | Recruiting |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Recruiting |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | Recruiting |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Recruiting |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Recruiting |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | Recruiting |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | Recruiting |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | Recruiting |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | Recruiting |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | Recruiting |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | Recruiting |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | Recruiting |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | Recruiting |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | Recruiting |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | Recruiting |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | Recruiting |
| El Paso Children's Hospital | El Paso | Texas | 79905 | Recruiting |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | Recruiting |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | Recruiting |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | Recruiting |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | Recruiting |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Recruiting |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | Recruiting |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | Recruiting |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
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 Sep 3, 2026 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05099003 live on ClinicalTrials.gov.