Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma
The standard first-line treatment for patients with metastatic RCC is IL-2 at higher doses,
but associated with higher frequency of toxicities. IL-2 given at lower doses have
demonstrated similar results than higher doses but it requires further study. RCC is highly
vascular and expresses high levels of VEGF. Bevacizumab is a monoclonal antibody directed
against the Vascular Endothelial Growth Factor (VEGF) responsible for angiogenesis.
The study is designed to evaluate a response defined as time to progression, safety and
toxicity in patients with metastatic renal cell carcinoma. Tissue correlation to evaluate
the impact of vascular VEGF on clinical outcome will be retrospectively performed
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
time to progression
Robert J. Amato, D.O.
The Methodist Hospital Research Institute
United States: Food and Drug Administration
|The Methodist Hospital Research Institute||Houston, Texas 77030|