Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma

Summary

The goal of this clinical research study is to learn if bevacizumab (Avastin®) can control metastatic renal cell carcinoma (RCC). The safety of the treatment will also be studied. Objectives: Primary: 1. To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progression. 2. Toxicities of therapy with bevacizumab in RCC. Secondary: Clinical: 1. Response rate 2. Duration of response 3. Overall Survival Preclinical: 1. Serum and plasma levels of matrix metalloproteinase 9 (MMP-9) and MMP-2, Interleukin 6 (IL-6), vascular endothelial growth factor (VEGF), and Basic Fibroblast Growth Factor (bFGF) pre- and post- therapy (optional studies). 2. Tissue expression of Phospho-epidermal growth factor receptor (EGFR), VEGF, vessel count CD31/34, AKT and Phospho-AKT, mitogen-activated protein kinase (MAPK), transforming growth factor-alpha (TGF-alpha), phospho-STAT3 and TUNEL post therapy (optional studies). 3. complementary DNA (cDNA) microarray analysis of tissue post-therapy (optional studies). 4. Tissue expression of tumor infiltrating lymphocytes and tumor antigens 5. Pathological response rate in primary tumor. 6. To evaluate the Single Nucleotide Polymorphisms (SNP) patterns in nephrectomy specimens from patients participating in the study.

Timeline

Start

2005-02

Primary completion

2012-08

Completion

2012-08

Drugs

Indications