Loading clinical trials...
Loading clinical trials...
An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.
Primary Objectives: I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS). II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI. Secondary Objectives: I. To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib. II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters. Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
April 1, 2009
Primary Completion Date
December 1, 2015
Completion Date
November 1, 2018
Last Updated
June 25, 2019
43
ACTUAL participants
mutation analysis
GENETIC
pharmacological study
OTHER
dynamic contrast-enhanced magnetic resonance imaging
PROCEDURE
sunitinib malate
DRUG
immunohistochemistry staining method
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
Abramson Cancer Center at Penn Medicine
NCT07485114
NCT06391099
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions