A Phase I Dose Escalation Trial to Evaluate Safety and Efficacy of Oral Sorafenib (Nexavar) With Regional Melphalan Via Normothermic Isolated Limb Infusion (ILI) in Patients With Intransit Extremity Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
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. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may also make tumor cells more sensitive to melphalan. Giving sorafenib together with an isolated limb infusion of melphalan may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with an isolated limb infusion of melphalan in treating patients with stage III melanoma of the arm or leg.
详细描述
OBJECTIVES:
Primary
- To determine the dose-limiting toxicities and maximum tolerate dose of systemic sorafenib tosylate in combination with regionally administered melphalan by isolated limb infusion in patients with stage IIIB or IIIC intransit extremity melanoma.
Secondary
- To characterize the safety and tolerability of this regimen in these patients.
- To assess the antitumor activity of this regimen, as evidenced by best overall response and duration of response, in these patients.
- To characterize the duration of progression-free survival of these patients.
- To characterize the pharmacokinetics of melphalan.
- To assess alterations in selected gene and protein expression profiles following treatment.
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 —（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
Sorafenib dose escalation
干预措施: protein expression analysis (Genetic)
Sorafenib dose escalation
干预措施: melphalan (Drug)
Sorafenib dose escalation
干预措施: sorafenib tosylate (Drug)
Sorafenib dose escalation
干预措施: gene expression analysis (Genetic)
Sorafenib dose escalation
干预措施: western blotting (Genetic)
Sorafenib dose escalation
干预措施: pharmacological study (Other)
结局指标
主要结局
Maximum tolerated dose
时间窗: 1 year
次要结局
- Duration of progression-free survival(3 years)
- Tumor gene and protein expression profiles following treatment(3 years)
- Safety and tolerability(2 years)
- Antitumor activity, as evidenced by best overall response and duration of response(3 years)
- Pharmacokinetics of melphalan(3 years)