Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response
Our proposed clinical study will:
- Provide an exploratory yet reliable and validated cadre of imaging studies done in
patients that yield a mechanistically-based understanding of: 1) predictive assays for
clinical benefit from standard sunitinib therapy, 2) measurement of efficacy during
standard sunitinib therapy, and 3) prognosis or other long term outcomes.
- Reveal a more detailed understanding of the in vivo mechanism of standard sunitinib
therapy in patient tumors, mechanistic information on why particular functional imaging
patterns are seen in treated patients, and clinical measures that are useful to
physicians for decision making and for explanation of efficacy or outcomes for
- Predict which patients may benefit from standard sunitinib therapy.
- Determine early in the course of treatment whether standard sunitinib therapy will be
efficacious and whether this can be used in future comparable patients.
- Show the outcome of patients with standard sunitinib treatment.
- Shed further information on the biological mechanism for the rapid decrease of FDG
uptake on FDG-PET imaging with standard sunitinib treatment.
It is our hypothesis that a set of biologically relevant imaging biomarkers (tumor
metabolism assessed with dynamic FDG-PET; tumor proliferation assessed with dynamic FLT-PET;
tumor blood flow assessed with H215O-PET and DCE MRI); tumor perfusion assessed with
DCE-MRI; and tumor blood volume/volume of distribution assessed with H215O-PET and DCE MRI)
in the same patient at baseline and then in the same patient at one of the post therapy time
points (1 week, 2 weeks, 3 weeks or 4 weeks) will provide either alone or more likely in
combination information that will predict which patients will most likely benefit from
standard sunitinib therapy and that an early response assessment is possible that is
predictive of a durable response to the therapeutic drug.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
After therapy with sunitinib it will be possible to compare the pre-therapeutic assessments with an early assessment of the same parameters in the same patients after therapy at various intervals.
John M Hoffman, MD
Huntsman Cancer Institute
United States: Food and Drug Administration
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|