NCT01026337

Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer

An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Cell Carcinoma
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
GENETIC	mutation analysis	Correlative study
OTHER	pharmacological study	Correlative study
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Undergo DCE-MRI
DRUG	sunitinib malate	Given orally
OTHER	immunohistochemistry staining method	Correlative study
OTHER	laboratory biomarker analysis	Correlative study

Timeline

• Start date: 2009-04-01
• Primary completion: 2015-12-01
• Completion: 2018-11-01
• First posted: 2009-12-04
• Last updated: 2019-06-25

Locations

1 site across 1 country: United States