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Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

NCT00694096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-12-01

Study results available
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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.

Conditions

  • Renal Cell Cancer

Interventions

DRUG

Sunitinib

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

Sponsors & Collaborators

Principal Investigators

  • John M Hoffman, MD · Huntsman Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694096 on ClinicalTrials.gov