Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Describe the gene expression of VEGF and non-VEGF from eligible patients being treatment with Sunitinib.
研究概览
简要总结
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 clinical trial is studying how well sunitinib works when given before and after surgery in treating patients with metastatic kidney cancer that can be removed by surgery.
详细描述
OBJECTIVES:
- To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in kidney cancer specimens from patients with metastatic renal cell carcinoma treated with sunitinib malate.
- To describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by response, duration of response, and time to progression in these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off study with other agents.
Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of circulating levels of VEGF and selected chemokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: neoadjuvant therapy (Procedure)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: adjuvant therapy (Procedure)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: sunitinib malate (Drug)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: gene expression analysis (Genetic)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: reverse transcriptase-polymerase chain reaction (Genetic)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: western blotting (Genetic)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: immunohistochemistry staining method (Other)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: laboratory biomarker analysis (Other)
Sunitinib
Sunitinib will be administered for 8 weeks prior to sugery
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Describe the gene expression of VEGF and non-VEGF from eligible patients being treatment with Sunitinib.
时间窗: at various points throughout the study duration
Describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors with the clinical efficacy of Sunitinib as measured by response, duration or response and time to progression
时间窗: at various points throughout the study duration
次要结局
未报告次要终点
研究者
Harry Drabkin
Director, Hematology Oncology Division
Medical University of South Carolina