Carcinoma, Renal Cell Clinical Trial
Official title:
Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma
The purpose of this study is to determine if the combination of therapy to strengthen the immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can prolong the time between the start of treatment and disease progression, decrease tumor size, as well as determine if the combination therapy is safer and less toxic than the standard treatment for 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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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