Kidney Cancer Clinical Trial
Official title:
An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Diagnostic procedures, such as MRI, may help doctors predict a patient's response
to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying MRI in predicting response to sunitinib malate in
patients with stage IV kidney cancer.
OBJECTIVES:
Primary
- 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
malate.
- Correlate genetic and histologic characteristics of the primary tumor with vascular
permeability by DCE-MRI.
Secondary
- 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
pharmacogenomic parameters.
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
sunitinib malate.
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
IHC.
;
Masking: Open Label, Primary Purpose: Diagnostic
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