Actively Recruiting
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
132
Participants Needed
127
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be between 12 months and 21 years of age at enrollment
- Newly diagnosed with diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG), including diffuse midline glioma (DMG)
- Patients suspected of having localized, newly diagnosed HGG without metastatic disease or have an institutional diagnosis of DIPG
- Signed informed consent obtained from patient or legal guardian
- For non-pontine tumors, tumor biopsy specimens must be submitted within 5 days of surgery
- Patients must have performance status scores of 0, 1, or 2 (Karnofsky or Lansky scales)
- Adequate blood counts and organ function within 7 days prior to enrollment
- Enrollment and treatment must begin within 31 days after diagnosis or surgery
- Patients with seizure disorders may enroll if seizures are well controlled with medication
You will not qualify if you...
- Prior therapy for central nervous system malignancy except surgery and steroid medications
- Currently receiving other investigational drugs or anti-cancer agents
- Patients 18 years or older with H3 K27M-wild type HGG
- Uncontrolled infections
- Prior solid organ transplantation
- Grade higher than 1 extrapyramidal movement disorder
- Known macular degeneration, uncontrolled glaucoma, or cataracts
- Metastatic disease
- Gliomatosis cerebri type 1 or 2 (except H3 K27M-mutant bithalamic tumors)
- Unable to receive protocol specified radiation therapy
- Pregnant or lactating females (unless agreeing not to breastfeed)
- Female patients of childbearing potential without a negative pregnancy test
- Sexually active patients of reproductive potential not agreeing to use two effective birth control methods during study and 90 days after last dose
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 127 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner Children's at Desert
Mesa, Arizona, United States, 85202
Actively Recruiting
3
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
5
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
6
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
7
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
8
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
9
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
10
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
11
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
12
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
13
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
14
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
15
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
16
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
17
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
18
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
19
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
20
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
21
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
22
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
23
Miami Cancer Institute
Miami, Florida, United States, 33176
Active, Not Recruiting
24
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
25
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
26
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
27
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
28
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
29
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
30
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
31
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
32
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
33
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
34
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
35
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
36
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
37
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
38
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
39
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
40
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
41
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
42
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
43
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
44
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
45
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
46
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
47
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
48
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Suspended
49
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
50
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
51
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
52
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
53
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
54
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
55
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
56
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
57
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
58
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
59
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
60
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
61
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
62
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
63
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
64
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
65
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
66
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
67
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
68
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
69
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
70
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
71
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
72
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
73
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
74
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
75
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
76
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
77
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
78
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
79
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
80
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
81
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
82
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
83
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
84
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
85
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
86
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
87
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
88
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
89
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
90
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
91
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
92
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
93
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
94
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
95
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
96
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
97
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Suspended
98
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
99
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
100
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
101
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
102
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
103
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
104
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
105
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
106
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
107
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
108
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
109
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
110
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
111
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
112
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
113
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
114
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
115
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
116
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Suspended
117
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
118
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
119
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
120
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Suspended
121
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
122
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
123
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
124
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
125
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
126
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Suspended
127
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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