Who can enter
- Children with newly diagnosed high-grade glioma
- Age: from 3 years to 18 years of age
Goal
In this study, we want to see if we can improve the standard treatment of high-grade gliomas by adding valproic acid to the treatment.
Background
A high-grade glioma is a tumor in the brain, brain stem or spinal cord. Unfortunately, the prognosis of children with high-grade glioma is generally not good. We normally treat children with high-grade glioma with radiotherapy and the chemotherapy temozolomide. In this study, we want to see if we can improve the treatment by adding valproic acid. We also want to see what the possible side effects of valproic acid are in these patients.
In many tumors, abnormalities are present within the tumor cells. In the tumor cells in a high-grade glioma, a certain protein is elevated. This protein is called HDAC. Valproic acid inhibits this protein. In addition, valproic acid may increase other proteins in the tumor cells. These are proteins that cause the tumor to stop growing, the tumor cells to die, or the tumor cells to become more sensitive to standard treatment with temozolomide. Therefore, it could potentially be an interesting drug in the treatment of high-grade gliomas.
Valproic acid is currently used as a drug in adults and children with epilepsy. Previous research has shown, among other things, that adults and children with high-grade glioma, who were given valproic acid for their epilepsy, responded better to usual treatment resulting in a longer survival. Most of the side effects of valproic acid are mild. Also, valproic acid does not seem to enhance the side effects of chemotherapy and radiotherapy.
In this study, we want to see if we can improve the standard treatment of children with high-grade glioma by adding valproic acid. All children in this study will be treated with valproic acid. These results will be compared with patients from a previous study who received the standard treatment without valproic acid. The purpose of the study is to compare the survival with the patients from the earlier study. We are looking at the time to relapse, second malignancy (cancer) or death. In addition, we are looking at the side effects of valproic acid in combination with the standard treatment of high-grade gliomas.