Sunitinib Before and After Surgery in Treating Patients With Stage IV Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00717587|
Recruitment Status : Unknown
Verified January 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 17, 2008
Last Update Posted : January 10, 2014
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 or disease||Intervention/treatment||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 girentuximab Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- To correlate histologic measures of tumor angiogenesis and VHL mutation/methylation status with clinical outcome in patients with stage IV renal cell carcinoma treated with sunitinib malate.
- To determine the effects of sunitinib malate on tumor vascular permeability by dynamic contrast-enhanced MRI and iodine I 124 chimeric monoclonal antibody G250 positron emission tomography (PET) after 2 weeks of therapy.
- To correlate steady-state plasma concentrations of sunitinib malate and angiogenic growth factors in serum with clinical outcome in these patients.
- Neoadjuvant therapy:Patients receive oral sunitinib malate once daily on days 1-14.
- Cytoreductive surgery: Patients undergo cytoreductive nephrectomy on day 16.
- Adjuvant therapy:Beginning at least 4 weeks after surgery, 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 with motexafin gadolinium and positron emission tomography with iodine I 124 chimeric monoclonal antibody G250 at baseline and after completion of neoadjuvant sunitinib malate (prior to cytoreductive nephrectomy).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||A Histopathologic and Imaging Study of Renal Cell Carcinoma Vasculature in the Setting of Sunitinib Therapy Prior to Cytoreductive Nephrectomy|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||July 2010|
- Progression-free survival
- Tumor regression as assessed by RECIST criteria
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): NCT00717587
|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||Abramson Cancer Center of the University of Pennsylvania|