Protocol
CNS1021: A Phase II Study of Sunitinib (NSC# 736511, IND# 74019) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients - A Children’s Oncology Group (COG) Study (ACNS1021)
Diseases
Brain Tumor : Recurrent, refractory or progressive glioma and ependymoma
Description
At this time, there is no standard treatment that works well for children who have a high-grade glioma or an ependymoma that has grown despite treatment, has come back after treatment or is not responding to treatment. Treatment options are based on many factors including the size and location of the tumor as well as the type of treatment the patient had before. Treatment may include one or more of the following: traditional chemotherapy, surgery, radiation therapy and/or treatment with a new “targeted” agent that inhibits pathways that are thought to be active within the tumor.
The drug used in this study is called sunitinib (Sutent®). As tumors grow, they need new blood vessels to grow with them in order to take in nutrients and survive. Sunitinib works by blocking the molecular pathways that support the growth of new blood vessels, including blood vessels in tumors. Sunitinib is also thought to block signals that are sent from one cancer cell to another “telling it to grow." We think that the way sunitinib works may make it a good therapy for the type of brain tumor that you have.
Sunitinib is approved by the Food and Drug Administration (FDA) for treating kidney cancer and cancers of the digestive system in adults. However, sunitinib is not FDA approved for treating children, so it is considered “experimental” and is most safely used within the context of a carefully monitored research study. Children and young adults taking part in this study using Sunitinib will start with the dose found to be safe in an earlier dose-finding study. Researchers now want to treat a group of patients with specific tumor types (high-grade glioma and ependymoma) to find out how effective sunitinib is at fighting this type of brain tumor.
Objectives
The overall goal of this study is to find out what effects (good and/or bad) sunitinib has on children and young adults with recurrent, progressive or refractory high-grade glioma or ependymoma brain tumors. Researchers will also study blood and tumor samples to learn more about the biology of ependymomas and high grade gliomas.
Eligibility
- Patients must be greater than or equal to 18 months and less than 22 years of age at the time of studyenrollment.
- Patients must be diagnosed with ependymoma or high grade glioma (WHO Grade III/IV)
- Participants must meet other eligibility requirements as outlined in the protocol
Exclusion
- Patients who have received more than 2 prior chemotherapy and/or radiation therapy regimens.
- Patients who received prior therapy with known risk for cardiovascular complications
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
Contact
Cynthia Wetmore, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
901-595-2544 or 901-595-4599
FAX: 901-595-5353
Or
Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
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.