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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00405366 |
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 the side effects and how well sorafenib works in treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.
Condition | Intervention |
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Kidney Cancer |
Drug: sorafenib tosylate Procedure: conventional surgery Procedure: gene expression profiling Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: mutation analysis Procedure: neoadjuvant therapy Procedure: spectroscopy |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Pilot Neoadjuvant Clinical Trial With Evaluation of Molecular Effects With Sorafenib Tosylate for Patients With Stage II or Greater Renal Cell Carcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | November 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, open-label, nonrandomized study.
Patients receive oral sorafenib tosylate twice daily for 4-8 weeks in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant therapy, patients undergo surgical resection of their kidney tumor.
Patients undergo blood and urine sample collection at baseline and after completion of treatment (i.e., at 4 and 8* weeks) for VEGF analysis. Samples are examined by enzyme-linked immunosorbent assay for measurement of serum and urinary VEGF levels.
NOTE: *Blood sampling at 8 weeks is only for those patients undergoing 8 weeks of study therapy.
Patients also undergo tissue sample collection at the time of nephrectomy. Tissue samples are examined by microarray analysis and IHC staining for expression of CD31/PECAM, HIF1α, and HIF2α. Immunohistochemical staining to identify biomarkers of microvessel density is also performed. Tissue samples are also examined for gene expression and metabolic profile by small molecule mass spectroscopy, as well as VHL gene mutation by VHL mutation analysis.
Patients are followed at 4-8 weeks after nephrectomy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of renal cell carcinoma (RCC) as confirmed by either of the following:
Stage II-IV disease, as defined by any of the following:
Deemed suitable for nephrectomy by a urologist
No known brain metastasis
PATIENT CHARACTERISTICS:
INR ≤ 1.5 AND PTT normal
No active bleeding diathesis
No cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 |
Principal Investigator: | W. Kimryn Rathmell, MD, PhD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000550127, UNC-LCCC-0603 |
Study First Received: | November 28, 2006 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00405366 |
Health Authority: | Unspecified |
stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Carcinoma, Renal Cell Kidney Diseases 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 |