A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma
I. To assess the feasibility of conducting a trial of tivozanib in the neoadjuvant setting
of localized (completely resectable) renal cell cancer (RCC).
I. To evaluate the safety of tivozanib in the neoadjuvant setting. II. To compare the tissue
before and after tivozanib for pharmacodynamic purposes (tumor infiltrating lymphocytes,
myeloid derived suppressor cells, necrosis in the primary tumor after exposure to
III. To assess the overall response rate of tivozanib in primary tumors and correlate the
radiographic changes, if any, to histo-pathological changes in the pathology specimen
IV. To compare the various growth factors (vascular endothelial growth factor [VEGF],
interleukin-8 [IL-8], placenta growth factor [P1GF]) at baseline and post treatment.
V. To assess the nephrectomy rate after applying neoadjuvant tivozanib in this primarily
resectable RCC population.
Patients receive tivozanib orally (PO) once daily (QD) on days 1-21. Treatment repeats every
28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25
days after completion of tivozanib, patients undergo curative nephrectomy.
After completion of study treatment, patients are followed up at 30 days.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib
Up to 30 days after surgery
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|