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| Diagnosis | Diffuse Intrinsic Pontine Glioma (DIPG), High-Grade Glioma (HGG) (including DMG) | Study Status | Open |
| Phase | I/II |
| Age | 12 Months to 21 Years | Randomisation | NO |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | Drug: Selinexor (oral)
Radiation: Radiation therapy |
| Last Posted Update | 2024-12-17 |
| ClinicalTrials.gov # | NCT05099003 |
International Sponsor
National Cancer Institute (NCI)Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Julie BennettCentres
Study Description
This clinical trial is testing a new treatment for children and young adults with aggressive brain tumors, including DIPG and high grade glioma with a specific genetic change (H3 K27M mutation). The treatment combines standard radiation therapy with a new medicine called selinexor, which may help stop cancer cells from growing and shrink tumors. Patients receive radiation for 5-7 weeks and take selinexor pills weekly during and after radiation for up to two years. The study will first find the safest dose of selinexor and then test how well it works. MRIs and follow-up visits help monitor progress. Researchers hope this treatment will improve outcomes for these difficult-to-treat brain tumors.
Inclusion Criteria
Pre-Enrollment
- Age: Patients must be 25 years old or younger.
- Diagnosis: Must have a suspected or confirmed diagnosis of DIPG or newly diagnosed high-grade glioma (HGG) that hasn’t spread.
- Consent: A parent or guardian, or the patient, must sign a consent form.
- Samples (non-DIPG tumours): Tumour samples from surgery or biopsy need to be submitted soon after the procedure (ideally within 5 days).
Main Enrollment
- Age: Patients must be between 1 and 21 years old.
- Diagnosis:
- DIPG: Must meet specific imaging or biopsy criteria.
- HGG: Must be newly diagnosed, without certain genetic mutations.
- Patients need to be in good overall health with normal lab results and no severe symptoms.
- Enrollment must happen within 31 days of diagnosis or surgery.
- A signed consent form is required.
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
