The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
University of Chicago
Chicago, Illinois, United States
Oncology/Hematology Associates
Peoria, Illinois, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Relative Tumor Size Change Following 8 Weeks of Therapy.
The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.
Time frame: 8 weeks
Percent Change in FDG-PETUptake Following 2 Weeks of Therapy
The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans.
Time frame: 2 weeks
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The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States