Spots Global Cancer Trial Database for Safety Study of Specific Tumor Target Drug Plus Immune System Therapy in Patients With Kidney Cancer

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Trial Identification

Brief Title: Safety Study of Specific Tumor Target Drug Plus Immune System Therapy in Patients With Kidney Cancer

Official Title: Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma

Study ID: NCT00440973

Conditions

Carcinoma, Renal Cell

Interventions

Bevacizumab

Interleukin-2

Study Description

Brief Summary: 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.

Detailed Description: 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