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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00727532 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with locally advanced or metastatic kidney cancer.
Condition | Intervention |
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Kidney Cancer |
Drug: sorafenib tosylate Procedure: TdT-mediated dUTP nick end labeling assay Procedure: diffusion-weighted magnetic resonance imaging Procedure: immunohistochemistry staining method |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Correlation of Pathologic Findings After Neo-Adjuvant Sorafenib With Results of Diffusion-Weighted Magnetic Resonance Imaging in Patients With Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma |
Estimated Enrollment: | 10 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients then undergo a nephrectomy or metastasectomy in week 5. Patients with residual metastatic disease may continue sorafenib tosylate twice daily and undergo a diffusion-weighted MRI (DW-MRI) every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo a DW-MRI of the abdomen and pelvis at baseline and prior to week 5 to evaluate microstructure tumor changes and to allow for prediction of sorafenib tosylate benefit. DW-MRI results are correlated with surgical and pathologic findings obtained at week 5.
Resected tumor tissue are analyzed for vascular density and to distinguish apoptotic cell death from necrotic cell death via immunohistochemistry and to measure apoptotic cell death via TUNEL assay.
After completion of study treatment, patients are followed every 3 months for 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria:
No known brain metastasis
PATIENT CHARACTERISTICS:
No history of an uncontrolled bleeding disorder including, but not limited to, any of the following:
No cardiac disease or condition including, but not limited to, any of the following:
No contraindication to MRI, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Principal Investigator: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
Principal Investigator: | Gary R. Mac Vicar, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Timothy M. Kuzel ) |
Study ID Numbers: | CDR0000598555, NU-07U1, BAYER-NU-07U1, NU-IRB-STU00003123 |
Study First Received: | August 1, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00727532 |
Health Authority: | Unspecified |
clear cell renal cell carcinoma hereditary clear cell renal cell carcinoma recurrent renal cell cancer stage I renal cell cancer |
stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Naphazoline Oxymetazoline Signs and Symptoms Urologic Diseases Guaifenesin |
Phenylephrine Kidney Neoplasms Carcinoma, Renal Cell Phenylpropanolamine Kidney Diseases Clear cell renal cell carcinoma Adenocarcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |