An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic Renal Cell Carcinoma
- Correlate tumor vascular permeability by dynamic contrast-enhanced MRI (DCE MRI) with
clinical outcome in patients with stage IV renal cell carcinoma treated with sunitinib
- Correlate genetic and histologic characteristics of the primary tumor with vascular
permeability by DCE-MRI.
- Correlate genetic and histologic characteristics of the primary tumor with clinical
outcome in patients treated with sunitinib malate.
- Collect tissue samples for potential future exploratory analyses of pharmacokinetic and
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats
every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of
Blood samples are collected at baseline and periodically during study for pharmacokinetic
analysis and for analysis of angiogenic growth factor levels. Tumor tissue samples are
collected at baseline for mutation analysis and for assessment of angiogenesis histology by
Masking: Open Label, Primary Purpose: Diagnostic
Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by IHC
Stephen Keefe, MD
Abramson Cancer Center of the University of Pennsylvania
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|