A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
Status:
Terminated
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
In this research study the investigators want to learn more about the effects, both good and
bad, when the study drug Ribociclib is given after radiation therapy.
The investigators are asking people to be in this research study that have been newly
diagnosed with a high grade glioma, and the tumor has been screened for the Rb1 protein, and
have recently finished radiation therapy. Patients with a DIPG or a Bi-thalamic high grade
glioma do not need to have tumor tissue screened for the Rb1 protein but do need to have
finished radiation therapy.
Tumor cells grow and divide quickly. In normal cells, there are proteins called
cyclin-dependent kinases (CDK 4 and 6) that control cell division. Another protein Rb1 also
controls cell division and works to stop cells from dividing so they do not become cancer
cells. But in cancer, the CDK 4 and 6 proteins are out of control making the cells divide and
grow quickly. The study drug, ribociclib stops the CDK 4 and 6 proteins. When the CDK 4 and 6
proteins are stopped, the normal Rb1 protein can now work to slow cell growth. For patients
with HGG, to be in this study tumor tissue must have a normal Rb1 protein. The researchers
think that if the study drug is given soon after radiation therapy, it may help improve the
effect of the radiation in stopping the tumor from growing.
The study drug, Ribociclib is considered investigational as it has not yet been approved by
the United States Food and Drug Administration. The study drug has been tested in children
and adults with cancer in prior research studies.