Who can enter
- Children and young adults with high-grade glioma
- Age: under 21 years old
Goal
The goal of this study is to learn more about the drugs abemaciclib and temozolomide. We are testing whether the combination of these drugs works better in children with high-grade glioma than temozolomide alone. We also want to find out if these drugs cause adverse reactions. Adverse reactions are usually called side effects.
Background
Not all children with high-grade glioma are cured, therefore we want to improve treatment. Also, the existing treatment is heavy and gives many side effects. We are looking for a treatment that gives fewer side effects.
The therapy evaluated in this trial targets specific characteristics of the tumor. This new treatment could work better and/or be less burdensome.
About 45 research participants from different countries are needed for this study. In the Netherlands, 3 research participants are expected to participate. The research participants will be placed in one of two treatment groups. A draw will determine in which group a research participant will be placed.
We will treat group A with abemaciclib + temozolomide. We will treat group B with temozolomide alone.
Abemaciclib is a tumor growth inhibitor. We expect that the addition of abemaciclib to temozolomide will inhibit the growth or recurrence of high-grade glioma.
Abemaciclib has not yet been well studied in patients with high-grade glioma, but has been used to treat other types of cancer. We want to find out if abemaciclib in combination with temozolomide could be a good treatment for high-grade glioma.