Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00717587 |
RATIONALE: Sunitinib 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 sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well sunitinib works when given before and after surgery in treating patients with stage IV kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: motexafin gadolinium Drug: sunitinib malate Genetic: comparative genomic hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: immunohistochemistry staining method Other: iodine I 124 chimeric monoclonal antibody G250 Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Histopathologic and Imaging Study of Renal Cell Carcinoma Vasculature in the Setting of Sunitinib Therapy Prior to Cytoreductive Nephrectomy |
Estimated Enrollment: | 20 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Tumor tissue samples are analyzed for VHL mutations and other somatic genetic mutations by mutation analysis; allelic loss or gain by comparative genomic amplification; microvessel density (MVD) by immunohistochemical staining for CD34 and CD105; pERK, SMA, Ki-67, HIF-1α, CAIX, macrophage migration inhibition factor (MIF), and CREB by multicolor analysis; and VEGF-R1 and -R2 and other relevant antigen expression by validated assays. Blood samples are analyzed for pharmacokinetics; angiogenic growth factor levels (e.g., free VEGF, basic FGF, and other markers); and polymorphisms in VEGF, VEGFR, VHL, and HIF.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of renal cell carcinoma
PATIENT CHARACTERISTICS:
No concurrent serious illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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 |
Principal Investigator: | Keith T. Flaherty, MD | University of Pennsylvania |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania ( Keith T. Flaherty ) |
Study ID Numbers: | CDR0000600332, UPCC-10807, PFIZER-807184 |
Study First Received: | July 16, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00717587 History of Changes |
Health Authority: | Unspecified |
stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Adjuvants, Immunologic Urogenital Neoplasms Motexafin gadolinium Urologic Neoplasms Angiogenesis Inhibitors Recurrence Carcinoma Antibodies, Monoclonal Photosensitizing Agents |
Antibodies Renal Cancer Radiation-Sensitizing Agents Urologic Diseases Sunitinib Kidney Neoplasms Carcinoma, Renal Cell Iodine Kidney Diseases Adenocarcinoma Immunoglobulins Neoplasms, Glandular and Epithelial |
Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Antibodies, Monoclonal Neoplasms by Site Urologic Diseases Kidney Neoplasms Sunitinib Therapeutic Uses Growth Inhibitors Kidney Diseases Angiogenesis Modulating Agents |
Dermatologic Agents Neoplasms by Histologic Type Growth Substances Motexafin gadolinium Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents Carcinoma, Renal Cell Adenocarcinoma Neoplasms, Glandular and Epithelial |