Kidney Cancer Clinical Trial
Official title:
A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before
surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
removed.
PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery
and to see how well it works in treating patients with localized or metastatic kidney
cancer.
OBJECTIVES:
Primary
- Determine the safety of sunitinib malate in patients with localized or metastatic renal
cell carcinoma.
- Determine the safety of surgery after 90 days of treatment with sunitinib malate in
these patients.
Secondary
- Determine response of these patients after 90 days of treatment with sunitinib malate.
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of
disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.
After completion of study treatment, patients are followed for 3 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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