TarGeT-A: Ribociclib & Everolimus Following Radiotherapy in Pediatric and Young Adult ND HGG - Clinical Trial
What is the Purpose of this Study?
In this study, people will take two medicines called ribociclib and everolimus for up to two years. Both medicines are taken by mouth every day in repeating monthly cycles. Ribociclib is taken for three weeks and then stopped for one week, while everolimus is taken the whole month.
Participants will visit the doctor before starting the study and then about once every four weeks during treatment. They may have more visits if needed. At these visits, doctors will do tests such as blood work, heart tests, scans like MRI, and a spinal tap. Participants will also answer questions about how they feel and their quality of life during the study.
This study is for people who have a type of brain or spine cancer called high grade glioma. This cancer has certain genetic changes that help it grow. The study focuses on cancers with changes in parts of the cell that control growth, such as the cell cycle or a pathway called PIK3 mTOR.
Who Can Participate in the Study?
People can join this study if they were already part of a screening study called TarGeT Screening. They must be between about 1 year old and 39 years old, and some younger groups must be under 21 years old. They must have a new diagnosis of a serious brain tumor called high grade glioma, including a type called diffuse intrinsic pontine glioma. Their tumor must have certain genetic changes that make cancer cells grow faster. They may have already had surgery or radiation, and some may have taken a medicine during radiation, but they cannot have had other cancer treatments for this tumor. Women who are pregnant or breastfeeding cannot take part in the study.
What is Involved?
The purpose of this study is to learn how two medicines called ribociclib and everolimus work when given together to people who have brain tumors after radiation treatment. Researchers think this combination of medicines may help shrink the tumor or slow down how fast it grows. The study will also look at how safe these medicines are when used together.
Study Details
