Condition: Malignant Glioma · Sponsor: National Cancer Institute (NCI)
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…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Children's Hospital of Alabama | Birmingham, Alabama, United States | Recruiting |
| Banner Children's at Desert | Mesa, Arizona, United States | Recruiting |
| Phoenix Childrens Hospital | Phoenix, Arizona, United States | Recruiting |
| Arkansas Children's Hospital | Little Rock, Arkansas, United States | Recruiting |
| Loma Linda University Medical Center | Loma Linda, California, United States | Recruiting |
| Miller Children's and Women's Hospital Long Beach | Long Beach, California, United States | Recruiting |
| Children's Hospital Los Angeles | Los Angeles, California, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| UCSF Benioff Children's Hospital Oakland | Oakland, California, United States | Recruiting |
| Kaiser Permanente-Oakland | Oakland, California, United States | Recruiting |
| Children's Hospital of Orange County | Orange, California, United States | Recruiting |
| Lucile Packard Children's Hospital Stanford University | Palo Alto, California, United States | Recruiting |
+ 115 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05099003