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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine

Criteria

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.