MRI in Predicting Response to Sunitinib Malate in Patients With Stage IV Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00915993
• Other study ID #: CDR0000643287
• Secondary ID: UPCC-03809809442
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2009
• Last updated: June 5, 2009
• Start date: May 2009

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

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 stage IV kidney cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• sunitinib malate

Genetic:
• mutation analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• pharmacological study

Procedure:
• dynamic contrast-enhanced magnetic resonance imaging

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by IHC			No
Primary	Progression-free survival			No
Secondary	Tumor regression as measured by RECIST criteria			No