drugset / Trial / NCT00038389

Study of Vioxx and Radiation Therapy for Brainstem Glioma

NCT00038389

Phase 1 Terminated 8 enrolled M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma.

Timeline

Start
2001-10
Primary completion
2004-10
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject rofecoxib Small molecule 10 mg/m2 Oral
Subject rofecoxib Small molecule 12.5 mg Oral

Indications