Everolimus With and Without Temozolomide in Adult Low Grade Glioma
Status:
Active, not recruiting
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001,
also known as Afinitor®) alone or with temozolomide has on the patient and the patient's
low-grade glioma. Everolimus is being investigated as an anticancer agent based on its
potential to prevent tumor cells from growing and multiplying. Specifically, there is a
protein called mTOR that we think helps many tumors to grow, and everolimus blocks the effect
of mTOR. Temozolomide is also an anticancer agent that prevents tumor cells from growing and
multiplying. About 159 people total will take part in this study. Patients will be assigned
to one of three treatment groups depending on the results of some tests done on their tumor.
Each group will have 53 patients in it. 2 groups will receive treatment with everolimus
alone, while the third group will receive treatment with both everolimus and temozolomide. In
this study, patients will be assigned to one of 3 treatment arms based on two characteristics
of their tumor, called "1p/19q" (this is a test of the tumor chromosomes) and "p-PRAS40"
(this is a test of a pathway in the tumor called mTOR). If the patient's tumor is 1p/19q
intact and p-PRAS40 positive, the patient will be assigned to Treatment Arm 1, and the
patient will receive everolimus alone. If the patient's tumor is 1p/19q intact and p-PRAS40
negative, the patient will be assigned to Treatment Arm 2 and the patient will receive
everolimus and temozolomide. If the patient's tumor is 1p/19q co-deleted, regardless of the
p-PRAS40 result, the patient will be assigned to Treatment Arm 3, and the patient will
receive everolimus alone.