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

Completed · Phase 1

Conditions studied: Glioma

In brief

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.

Key facts

Study ID

NCT00532948

Run by

Hoffmann-La Roche

People needed

24

Starts

2007-05-01

Expected to finish

2010-10-01

Last updated by the study team

2016-12-07

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
• uncontrolled infection;
• known 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 — Boston, Massachusetts, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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