CDKLEE: A Phase I, Multi-Center, Open-Label Study of LEE011 in Patients with Malignant Rhabdoid Tumors and Neuroblastoma (Novartis Protocol No. CLEE011X2102)


Brain Tumor : Relapsed / progressive malignant rhabdoid tumor or neuroblastoma


This is a phase I study of a drug called LEE011. This is called a Phase I study because the goal is to find the highest dose of LEE011 that can be given safely. LEE011 is investigational because it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of these cancers. LEE011 is currently not “on the market” (available for you to buy) in any country. There are two parts to this phase I study, a dose finding part and a dose expansion part.

In the dose finding part, participants with relapsed or progressed malignant rhabdoid tumors (MRT) or neuroblastoma will receive LEE011. In addition, participants whose tumors have genetic abnormalities in the CDK4/6 pathway can join the study in the dose finding part. If, during the first 28 days of starting therapy (Cycle 1), no significant problems are observed, a second group of participants will be given a higher dose of LEE011. This step-wise increase in doses will continue until the highest dose of LEE011 that does not cause unwanted problems or side effects is identified. In the dose expansion part, participants with either neuroblastoma or MRT will receive the highest dose of LEE011 found to be safe in the dose finding part of the study.


Eligibility criteria, among others, include:


Giles Robinson, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: (901) 595-2544 or (901) 595-4599
FAX: (901) 595-6211


Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: (901) 595-2544
FAX: (901) 595-6211

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.