A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
- Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical
improvement, in patients with recurrent or progressive meningioma.
- Determine the 6-month progression-free survival of these patients.
- Describe the response rate and overall survival of these patients.
- Determine the safety of vatalanib in these patients.
- Correlate the response rates with expression of vascular endothelial growth factor,
epidermal growth factor receptor, platelet-derived growth factor, and HER2.
- Develop exploratory data concerning surrogate markers of angiogenic activity in vivo
using magnetic resonance perfusion.
OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28
days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the 6 month progression free survival
MRI will be done before treatment starts and then every 2 months while on study treatment to determine 6 month progression free survival
MRI with MR Perfusion (optional) will be done before treatment and then every 2 months while on study treatment
Jeffrey J. Raizer, MD
United States: Institutional Review Board
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|