Inducing Systemic Immunity and Regressions in Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.
研究概览
简要总结
In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.
详细描述
Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple cutaneous or subcutaneous metastases of melanoma
排除标准
- •Visceral metastases on admission.
- •No current chemotherapy or immunotherapy.
- •Note study performed between 1978 and 2002 before current therapies were available.
结局指标
主要结局
Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.
时间窗: Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.
The biopsies were examined by a licensed pathologist for the presence of dense lymphocytic infiltrates.
次要结局
- Complete regression of a metastasis(Complete regressions of all injected and never-injected metastases occurred in different pts after 13 weeks to 48 months of injections. Pts with progressive disease were switched to chemotherapy at any point in the study.)
研究者
Fred T. Valentine
Professor of Medicine
NYU Langone Health