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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915993
First Posted: June 8, 2009
Last Update Posted: June 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  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 stage IV kidney cancer.


Condition Intervention
Kidney Cancer Drug: sunitinib malate Genetic: mutation analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: dynamic contrast-enhanced magnetic resonance imaging

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by IHC
  • Progression-free survival

Secondary Outcome Measures:
  • Tumor regression as measured by RECIST criteria

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915993


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Keefe, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Stephen Keefe, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00915993     History of Changes
Other Study ID Numbers: CDR0000643287
UPCC-03809
809442
PFIZER-UPCC-03809
First Submitted: June 5, 2009
First Posted: June 8, 2009
Last Update Posted: June 8, 2009
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

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