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A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma
This clinical trial studies tivozanib before surgery in treating patients with localized kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth factors needed for cell growth.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 14, 2013
Primary Completion Date
June 14, 2013
Completion Date
December 2, 2013
Last Updated
August 15, 2022
tivozanib
DRUG
therapeutic conventional surgery
PROCEDURE
Lead Sponsor
Roswell Park Cancer Institute
Collaborators
NCT06349642
NCT04473781
Data Source & Attribution
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