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

Completed

• Conditions: Stage III Renal Cell Cancer; Renal Cell Carcinoma; Stage IV Renal Cell Cancer
• Interventions: Genetic: mutation analysis; Other: pharmacological study; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Drug: sunitinib malate; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

• Registration Number: NCT01026337
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-04
• Primary Completion: 2015-12
• Study Completion: 2018-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	mutation analysis	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.
Arm I	pharmacological study	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.
Arm I	dynamic contrast-enhanced magnetic resonance imaging	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.
Arm I	laboratory biomarker analysis	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.
Arm I	immunohistochemistry staining method	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.
Arm I	sunitinib malate	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival
Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)

Secondary Outcome Measures

Name	Time	Method
Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Trial Locations

Locations (1)

Abramson Cancer Center of The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States