NCT01769885

Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer

A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stage II Renal Cell Cancer
• Stage III Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	tivozanib	Given PO
PROCEDURE	therapeutic conventional surgery	Undergo nephrectomy

Timeline

• Start date: 2013-03-14
• Primary completion: 2013-06-14
• Completion: 2013-12-02
• First posted: 2013-01-17
• Last updated: 2022-08-15