Clinical trial NCT01026337: Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer
Official title: An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Keywords: recurrent renal cell cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

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.

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

Primary outcomes:
measure: Progression-free survival
measure: 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 outcomes:
measure: Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Keefe
role: PRINCIPAL_INVESTIGATOR
References: