Sarcoma Clinical Trial
Official title:
A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor
and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with
recurrent or progressive meningioma.
OBJECTIVES:
Primary
- Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical
improvement, in patients with recurrent or progressive meningioma.
Secondary
- 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.
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