Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
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.