A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. To assess the feasibility of conducting a trial of tivozanib in the neoadjuvant setting
of localized (completely resectable) renal cell cancer (RCC).
SECONDARY OBJECTIVES:
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
tivozanib).
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
post-nephrectomy.
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.
OUTLINE:
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.
Interventional
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
No
Saby George
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 220412
NCT01769885
March 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |