A Study of Capecitabine [Xeloda] and Concomitant Radiation Therapy in Children and Adolescent Patients With Newly Diagnosed Brainstem Glioma

• Overall survival distribution: OS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Safety Profile: Adverse Events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Pharmacokinetics of capecitabine [Xeloda] and its metabolites [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
• Safety: Laboratory Parameters [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

This open-label study will evaluate the progression-free survival, safety and pharmacokinetics of capecitabine [Xeloda] rapidly disintegrating tablets and concomitant radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma. Xeloda will be administered 650 mg/m2 orally twice daily during radiation phase (courses 1-3) followed by a two-weeks break and Xeloda will be administered 1250 mg/m2 during post radiation (courses 4-6). During each course, Xeloda will be administered for 14 consecutive days followed by a 7-days rest period. Dose can be adjusted according to toxicity and body surface area. The anticipated time on study drug is 18 weeks.

Inclusion Criteria:

• pediatric and adolescent patients >/=3 to <18 years of age
• patients must have a newly diagnosed non-disseminated intrinsic infiltrating brainstem glioma
• Karnofsky Performance Scale (if >16 years of age) or Lansky Performance Score (if </=16 years of age) >/= 50% assessed within two weeks prior to registration to study
• patients must not have received any prior chemotherapy or bone marrow transplant for the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
• adequate organ function

Exclusion Criteria:

• patients receiving any other anticancer or experimental drug therapy
• patients with uncontrolled infection
• known DPD deficiency