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

Completed · Phase 2

Conditions studied: Brainstem Glioma

In brief

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

Key facts

Study ID

NCT01118377

Run by

Hoffmann-La Roche

People needed

45

Starts

2007-05-01

Expected to finish

2013-04-01

Last updated by the study team

2014-02-06

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients receiving any other anticancer or experimental drug therapy.
• Patients with uncontrolled infection.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.

Where it is running

• Study site — San Francisco, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Chicago, Illinois, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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