Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients
Status:
Terminated
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to
mobilize immune effector cells that recognize and destroy cancer. The investigators have
recently observed a 50% objective response rate (16% CR) in mRCC patients treated with
autologous tumor lysate -dendritic cell (DC)-vaccine, IL-2 and interferon alfa (IFN). New
agents inhibiting vascular endothelial growth factor (VEGF) pathways have demonstrated
significant benefit in mRCC patients as well, but rarely induce CRs. High blood VEGF is
associated with poor response to IL-2 and can cause tumor specific immune dysregulation. To
test whether complementary mechanisms of immune activation and disruption of regulatory
pathways enhance outcome the investigators plan to treat 24 mRCC patients in a phase II trial
using bevacizumab, DC vaccine, IL-2, and IFN. Observations from this project will be used in
the development of novel cancer therapies which, if successful, will decrease the burden of
cancer on the public.
The investigators propose to determine 1) the objective clinical response rate to treatment
and progression free survival, 2) the clinical and autoimmune related toxicity profile of
therapy, and 3) the treatment related tumor-specific immune response and the relationship of
tumor-specific immune response and objective clinical response.