Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Response rate and toxicity
研究概览
简要总结
Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma.
Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status.
排除标准
- •Brain mets
结局指标
主要结局
Response rate and toxicity
时间窗: 6 months
次要结局
未报告次要终点
