Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma
- To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in
kidney cancer specimens from patients with metastatic renal cell carcinoma treated with
- To describe the association between quantitative gene expression levels of VEGF and
non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by
response, duration of response, and time to progression in these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after
completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for
response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate
once daily for up to 12 months in the absence of disease progression or unacceptable
Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off
study with other agents.
Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of
nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene
expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or
IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of
circulating levels of VEGF and selected chemokines.
After completion of study therapy, patients are followed monthly.
Masking: Open Label, Primary Purpose: Treatment
Baseline gene expression of plasma biomarkers of tumor angiogenesis and response (i.e., VEGF and non-VEGF angiogenic growth factor genes)
Harry A. Drabkin, MD
Medical University of South Carolina
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|