A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities,
of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed
diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered
twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of
radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard
dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week
break. The anticipated time on study treatment is 3-12 months, and the target sample size
will not exceed 30 evaluable patients.