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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given PO
Undergo nephrectomy
Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib
Time frame: Up to 30 days after surgery
Short-term efficacy defined as a composite of presence of partial response/stable disease/complete response assessed radiographically and correlated with the nephrectomy specimen per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Response rate will be examined using the sample proportion and corresponding 95% confidence interval.
Time frame: Up to 30 days after surgery
Incidence of adverse events evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 30 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.