MRI in Predicting Response to Sunitinib Malate in Patients With Stage IV Kidney Cancer
Recruitment status was: Recruiting
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.
Drug: sunitinib malate
Genetic: mutation analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: dynamic contrast-enhanced magnetic resonance imaging
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic Renal Cell Carcinoma|
- Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by IHC [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Tumor regression as measured by RECIST criteria [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915993
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Stephen Keefe, MD||Abramson Cancer Center of the University of Pennsylvania|