Actively Recruiting
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
97
Participants Needed
36
Research Sites
223 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 the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Giving selinexor in combination with usual chemotherapy (temozolomide) may shrink or stabilize the tumor better than the usual chemotherapy with temozolomide alone in patients with recurrent glioblastoma.
CONDITIONS
Official Title
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed glioblastoma (IDH wild-type, MGMT promoter methylated) with resection or biopsy at first recurrence
- Measurable disease with at least one contrast-enhancing lesion of 10 mm or more on MRI
- Received first-line treatment of temozolomide plus radiotherapy
- No prior therapy for recurrent disease other than resection or biopsy
- Age 18 years or older
- Karnofsky performance status 60% or higher (ECOG 0-1)
- Absolute neutrophil count of at least 1,500/mcL
- Platelet count of at least 100,000/mcL
- Hemoglobin level of at least 10 g/dL
- Total bilirubin less than or equal to 2 times institutional upper limit of normal (ULN)
- AST/ALT less than or equal to 3 times institutional ULN
- Glomerular filtration rate of at least 30 mL/min/1.73 m²
- HIV-positive patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B virus infection must have undetectable viral load on suppressive therapy
- Patients with hepatitis C virus infection must be treated and cured or have undetectable viral load if currently treated
- Patients with prior or concurrent malignancy that does not interfere with safety or efficacy
- Cardiac function classified as New York Heart Association class 2B or better
- Women of child-bearing potential and men must agree to use contraception during and after study
- Ability to understand and sign informed consent, or have a legally authorized representative
You will not qualify if you...
- Incomplete recovery of organ and marrow function after last chemotherapy
- Residual toxicities greater than grade 1 from prior anti-cancer therapy except alopecia
- Receiving any other investigational agents
- Previous treatment with bevacizumab
- Allergic reactions to selinexor, temozolomide, or related compounds
- Hypersensitivity to dacarbazine
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding women
- Hospitalized patients with severe COVID-19 who are 75 years or older, or with high-risk COVID-GRAM score, or elevated LDH and D-Dimer levels contraindicating low-dose selinexor use pending further results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
4
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
5
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
6
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
7
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
8
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
9
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
11
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
12
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
13
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
14
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
15
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
16
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
17
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
18
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
19
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
21
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
22
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
Actively Recruiting
23
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Active, Not Recruiting
24
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
25
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Active, Not Recruiting
26
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
27
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
28
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
29
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
30
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
31
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
32
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
33
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Active, Not Recruiting
34
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
35
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
36
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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