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 |
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.
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
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