This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
50mg/day for 4 weeks
Conducted prior to administration of sunitinib therapy
Nephrectomy 2-4 weeks after last dose of Sunitinib
Time to clinical recurrence after surgery for high risk localized disease.
Time frame: 1 year
Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery
Toxicities will be graded using the NCI Common Toxicity Criteria, version 3.0
Time frame: 1 year
Effect of Sunitinib on pretreatment serum levels of Vascular Endothelial Growth Factor (VEGF). Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining)
Time frame: 1 year
Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib.
Time frame: 1 year
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Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery. Biomarker evaluation of tissue prior to 4 week administration of Sunitinib