Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

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: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:47:08 PM