drugset / Trial / NCT00038389
Study of Vioxx and Radiation Therapy for Brainstem Glioma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rofecoxib | Small molecule | 10 mg/m2 | Oral |
| Subject | rofecoxib | Small molecule | 12.5 mg | Oral |