Kidney Cancer Clinical Trial
Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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