Phase II Randomized Study of Monoclonal Antibody VEGF in Patients With Unresectable Advanced Renal Cell Cancer
OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression,
angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer.
II. Evaluate serum antibody levels and biologically active vascular endothelial growth
factor levels in the plasma of patients treated with this regimen.
III. Evaluate the toxicity of this regimen in these patients.
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by prior
interleukin-2 therapy (yes vs no).
Patients are randomized to receive either placebo or one of two doses of monoclonal antibody
VEGF. Following an initial loading dose, patients receive one dose of the study drug
intravenously every 2 weeks for up to 2 years in the absence of disease progression.
Patients who are given placebo and experience disease progression are offered monoclonal
antibody VEGF and thalidomide if there are no contraindications.
A total of 150 patients will be accrued for this study over 2 years.
Primary Purpose: Treatment
James Chung-Yin Yang
National Cancer Institute (NCI)
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|