MRI in Predicting Response to Sunitinib Malate in Patients With Stage IV Kidney Cancer
Conditions
Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
stage IV renal cell cancer, recurrent renal cell cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: sunitinib malate Type: Drug
Name: mutation analysis Type: Genetic
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Name: pharmacological study Type: Other
Name: dynamic contrast-enhanced magnetic resonance imaging Type: Procedure
Overall Status
Recruiting
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 stage IV kidney cancer.
Detailed Description
OBJECTIVES:

Primary

- Correlate tumor vascular permeability by dynamic contrast-enhanced MRI (DCE MRI) with clinical outcome in patients with stage IV renal cell carcinoma treated with sunitinib malate.

- Correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.

Secondary

- Correlate genetic and histologic characteristics of the primary tumor with clinical outcome in patients treated with sunitinib malate.

- Collect tissue samples 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.

Blood samples are collected at baseline and periodically during study for pharmacokinetic analysis and for analysis of angiogenic growth factor levels. Tumor tissue samples are collected at baseline for mutation analysis and for assessment of angiogenesis histology by IHC.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Stage IV disease

- Has undergone nephrectomy

- Archival tumor tissue samples available

- No history or clinical evidence of brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- WBC ≥ 3,000/mm^3

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min

- Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN for patients with Gilbert's disease)

- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN for patients with liver metastases)

- INR ≤ 1.5

- PTT normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication

- No hypertension that cannot be controlled with medication (i.e., diastolic blood pressure ≥ 100 mm Hg despite optimal medical therapy)

- No cardiac dysrhythmias ≥ grade 2 by NCI CTCAE v3.0

- No concurrent serious illness including, but not limited to, the following:

- Ongoing or active infection requiring parenteral antibiotics

- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina)

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade 2 within the past year

- Psychiatric illness and/or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior antiangiogenesis therapy

- Prior radiotherapy to a symptomatic site of metastatic disease is allowed

- At least 2 weeks since prior radiotherapy and recovered

- No other concurrent investigational therapies

- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or St. John's wort
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers - 800-474-9892
Start Date
May 2009
Sponsors
University of Pennsylvania
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page