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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01026337
First received: December 2, 2009
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Renal Cell Carcinoma
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Genetic: mutation analysis
Other: pharmacological study
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Drug: sunitinib malate
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

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.

Genetic: mutation analysis
Correlative study
Other: pharmacological study
Correlative study
Other Name: pharmacological studies
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Other Name: DCE-MRI
Drug: sunitinib malate
Given orally
Other Names:
  • SU011248
  • SU11248
  • sunitinib
  • Sutent
Other: immunohistochemistry staining method
Correlative study
Other Name: immunohistochemistry
Other: laboratory biomarker analysis
Correlative study

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026337

Contacts
Contact: Stephen Keefe, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephen Keefe    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Stephen Keefe         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Stephen Keefe Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01026337     History of Changes
Other Study ID Numbers: UPCC 03809, NCI-2009-01414
Study First Received: December 2, 2009
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014