Trial information
A Study of Xeloda (Capecitabine) plus Radiation Therapy in Children With Newly Diagnosed Gliomas
Status: Recruiting
Protocol number: NO18517
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A dose-escalation study of Xeloda plus radiation therapy in pediatric patients with newly diagnosed non-disseminated, intrinsic brainstem gliomas and high grade gliomas.
Brief summary: 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 is <100 individuals. Target sample size is 60.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Glioma
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. MTD and DLT, measured by clinical and neurological examination, AEs, laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 1. Pharmacokinetic profile of capecitabine Time frame: Throughout study
2. Antitumor activity, assessed by MRI scan. Time frame: At intervals throughout study
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.
Gender: Males or Females
Age limits: Min: 3 Years Max: 21 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2007
Trial registration date: 09/20/2007
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- San Francisco, CA
- Washington, DC
- Chicago, IL
- Boston, MA
- Durham, NC
- Philadelphia, PA
- Pittsburgh, PA
- Houston, TX
- Seattle, WA
