Research
Capecitabine and Radiation for Treating Brain Tumors
Capecitabine and Radiation Therapy in Treating Young Patients with Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma
Protocol Description
This Phase I, multi-center study seeks to establish dosing parameters for capecitabine given in combination with radiation therapy, while determining how well they work together in the treatment of brain tumors in children. The drug, capecitabine, used in this study is an anti-cancer drug that is approved for adults with some types of colon cancer but not for the treatment of brainstem gliomas or high-grade gliomas. Radiation therapy increases the amount of an enzyme in brain tumors, and this increase, combined with capecitabine may increase the activity against the tumor.
Eligibility Criteria
The group-wide study is currently accepting male and female patients from the age of 3 to 21 years of age who satisfy study criteria, and have been diagnosed with a brainstem glioma or a high-grade glioma that cannot be completely removed by the neurosurgeon.
Boys: 3 to 21 years
Girls: 3 to 21 years
Requirements
Participants will undergo radiation therapy while taking the chemotherapy drug capecitabine orally in a tablet form. Following the completion of radiation, a separate schedule will be followed for the drug. Throughout the study, blood draws, physical exams and scans will be administered to determine tumor status.
Visits: Number varies depending on participant’s response to chemotherapy.
Duration: Depending on outcomes, treatment may extend 20 weeks with patient’s health monitored for an additional 2 years after treatment ends.
Status: Closed to Enrollment
Source of Support
National Cancer Institute
Hoffman LaRoche, Inc.
Additional Resources
Study Description at National Institutes of Health
Primary Investigator(s)
Regina I. Jakacki, MD
Contact Information
Sharon DiBridge, CRA
412-692-7070
Angela Krol, Research RN, BSN
412-692-8047
