NCT00421811已完成1 期
An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).
Adherex Technologies, Inc.14 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 14
- 主要终点
- To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
研究概览
简要总结
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Signed written informed consent
- •Male and female patients > or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate
- •Measurable disease
- •Disease site(s) must be distal to the planned site of tourniquet placement
- •Available for immunohistochemical testing of N-cadherin expression tumor tissue
- •Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG
排除标准
- •Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay)
- •Stage IV melanoma
- •Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
- •History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
- •Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
- •Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities
- •Allergic reaction to any therapeutic peptide or to melphalan
结局指标
主要结局
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
时间窗: By Week 12
次要结局
未报告次要终点
研究者
研究点 (14)
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