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临床试验/NCT00287131
NCT00287131Unknown2 期

Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2006年1月1日最近更新:
适应症

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

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

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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