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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026337
• Other study ID #: UPCC 03809
• Secondary ID: NCI-2009-01414
• Status: Completed
• Start date: April 2009
• Est. completion date: November 2018

Study information

• Verified date: June 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00915993

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion

• AJCC stage IV or locally advanced (or inoperable) renal cell carcinoma for which archival tissue is available

• No prior anti-angiogenic therapy

• Prior radiation therapy to a symptomatic site of disease is allowed

• ECOG performance status of 0, 1 or 2

• White Blood Count >= 3,000/mm^3

• Absolute Granulocyte Count >= 1,500/mm^3

• Platelet Count >= 100,000/mm^3

• Serum creatinine =< 2.0 x upper limit of normal (ULN) OR serum creatinine clearance (CrCl) >= 40 ml/min

• Total Bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert's disease)

• AST/ALT =< 2.5 x ULN (=< 5.0 ULN in the presence of liver metastases)

• INR =< 1.5 and a PTT within normal limits; patients who are taking warfarin must have documentation of an INR =< 1.5 and a PTT within normal limits prior to the initiation of anticoagulation to rule out a baseline coagulopathy

• Patient must not have pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication

• Patient must not have hypertension that cannot be controlled by medications (diastolic blood pressure >= 100 mm Hg despite optimal medical therapy)

• Patient must not have ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >= 2

• Patients must not receive any other investigational agents during the period on study

• Patients must not have a history or clinical evidence of brain metastasis; however, patients with resected or radiated brain metastases are eligible

• Patients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication

• Patients must not have a serious intercurrent illness including, but not limited to, grade II or greater peripheral vascular disease within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements

• Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's wort

• Women must not be pregnant or breast-feeding

• All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation

Related Conditions & MeSH terms

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

Intervention

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
• laboratory biomarker analysis
Correlative study

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival
Primary	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	Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria