Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
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.