A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas

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.

Inclusion Criteria:

• patients >=3 and <=21 years of age;
• newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma;
• Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;
• adequate organ function.

Exclusion Criteria:

• previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
• uncontrolled infection;
• known DPD deficiency.