Kidney Cancer Clinical Trial
Official title:
Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma
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. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well sunitinib works when given before and
after surgery in treating patients with metastatic kidney cancer that can be removed by
surgery.
OBJECTIVES:
- 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
sunitinib malate.
- 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
toxicity.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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