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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
monoclonal antibody with anti-angiogenesis properties used as chemotherapy
immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T \& B lymphocyte proliferation
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States
time to progression
currently data no longer available
Time frame: During study (currently data no longer available)
Collect data on tumor responses produced by interleukin-2 and Bevacizumab
currently data no longer available
Time frame: During study (currently data no longer available)
Evaluate safety and toxicity of the combination of interleukin-2 and Bevacizumab for patients with progressive metastatic renal cell carcinoma.
currently data no longer available
Time frame: During study (currently data no longer available)
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