NCT02339987终止不适用
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Evaluate Feasibility of conducting TIL procurement in a single-site setting
研究概览
简要总结
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)
详细描述
The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose.
- •Patients must be > 15 years of age and must have metastatic melanoma.
- •Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery.
- •Patients must be able to understand and sign the Informed Consent document.
- •Patients must be able to complete the supplemental data form
排除标准
- •women who are pregnant or breastfeeding
- •inability to give consent
结局指标
主要结局
Evaluate Feasibility of conducting TIL procurement in a single-site setting
时间窗: 5 years
Cell viability, viable number and TIL potency using standardized methods
Evaluate Safety of conducting TIL procurement in a single-site setting
时间窗: 5 separate TIL procedures
lab personnel training during procurement, isolation, testing tumor reactivity and cryopreservation
次要结局
- To determine whether TIL Procurement, isolation, testing tumor reactivity and cryopreservation can be performed at John Wayne Cancer Institute (JWCI) and Providence Saint John's Health Center (PSJHC) and infused into patients(5 years)
研究者
研究点 (1)
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