Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism [Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)[Lodge 2000], tumor perfusion (DCE-MRI)[Tofts 1999, Tofts 1997, Parker 1999]; and tumor blood volume (H215O-PET, DCE MRI)[Lodge 2000, Tofts 1999, Tofts 1997] 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). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response|
- 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. [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Imaging studies with complete analyses will be provided on all patients prior to institution of sunitinib therapy as well as after therapy at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients or 4 weeks in 5 patients) after institution of sunitinib therapy at 37.5 mg orally/day.
Imaging studies include:
FDG-PET scans FLT-PET scans H215O-PET scans DCE-MRI scans
Other Name: Sutent®
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 patients.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694096
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||John M Hoffman, MD||Huntsman Cancer Institute|