NCT05099003 · National Cancer Institute (NCI)
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
What this study 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.
View original scientific 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. Glioma is a type of cancer that occurs in the brain or spine.
Interventions
PROCEDURE
Biopsy Procedure
Undergo a biopsy
PROCEDURE
Magnetic Resonance Imaging
Undergo a MRI
RADIATION
Radiation Therapy
Undergo radiation therapy
DRUG
Selinexor
Given orally
Primary outcome measures
Maximum tolerated dose
Time frame: From day 1 of selinexor treatment until the start of maintenance therapy, assessed up to 10 weeks from treatment start date
Defined as the highest dose of selinexor in combination with standard of care radiation therapy that does not cause unacceptable side effects.
Event free survival (EFS)
Time frame: From the date of enrollment until disease progression date, secondary malignant neoplasm occurrence date, death date of any cause, or last follow-up date, assessed up to 5 years
Will be calculated for diffuse midline glioma/ high grade glioma patients. EFS curve will be estimated by Kaplan Meier estimates.
Overall Survival (OS)
Time frame: From the date of enrollment until death date of any cause or last follow-up date, assessed up to 5 years
Will be calculated for diffuse intrinsic pontine glioma patients. The OS curve will be estimated by Kaplan Meier estimates.
Overall response rate
Time frame: Up to 5 years
Defined as the proportion of patients whose best response is partial response or complete response.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PRE ENROLLMENT: Patients must be =\< 25 years of age at the time of enrollment on APEC14B1 part A central nervous system (CNS)/high grade glioma (HGG) pre-enrollment eligibility screening
- Please note:
- This required age range applies to pre-enrollment eligibility for all HGG patients. Individual treatment protocols may have different age criteria.
- Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are \>= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).
- PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG
- Please note: there are specific radiographic criteria for DIPG patient enrollment on ACNS1821 (Step 1)
- As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
- PRE ENROLLMENT:
- For patients with
Where
- Birmingham, Alabama
- Mesa, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
- Oakland, California
- Orange, California
- Palo Alto, California
- San Diego, California
- San Francisco, California
And 82 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations