MRI in Predicting Response to Sunitinib Malate in Patients With Stage IV Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00915993|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Masking:||None (Open Label)|
|Official Title:||An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic Renal Cell Carcinoma|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||May 2011|
- Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by IHC
- Progression-free survival
- Tumor regression as measured by RECIST criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915993
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892|
|Principal Investigator:||Stephen Keefe, MD||Abramson Cancer Center of the University of Pennsylvania|