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



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 21
Updated:4/21/2016
Start Date:May 2007
End Date:April 2013

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A Dose-escalation Study of Xeloda Plus Radiation Therapy in Pediatric Patients With Newly Diagnosed Non-disseminated, Intrinsic Brainstem Gliomas and High Grade Gliomas.

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.


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.
We found this trial at
9
sites
2578
mi
from 91732
Boston, MA
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1729
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from 91732
Chicago, IL
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2202
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from 91732
Durham, NC
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1357
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from 91732
Houston, TX
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2375
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from 91732
Philadelphia, PA
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2119
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from 91732
Pittsburgh, PA
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355
mi
from 91732
San Francisco, CA
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964
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from 91732
Seattle, WA
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2281
mi
from 91732
Washington,
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