A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Pediatric Brain Tumor Consortium
• Treatments: Capecitabine

Criteria

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 2 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 dihydropyrimidine dehydrogenase (DPD) deficiency.