NCT01925118终止2 期
Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- 12-week modified immune-related response rate
研究概览
简要总结
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant melanoma or renal cell carcinoma
- •At stage IV or relapse
- •At least one prior chemotherapy including targeted agents
- •At least one haploidential or partially matched-HLA donor
- •ECOG performance status 0-1
- •Age 18-75 years
- •Measurable lesion
- •Adequate bone marrow, liver, and renal functions
排除标准
- •Chemotherapy within 4 weeks
- •Stem cell transplantation
- •Active CNS metastasis
- •Hypersensitivity to IL-2
结局指标
主要结局
12-week modified immune-related response rate
时间窗: 12-week
次要结局
- Overall response rate based on RECIST v1.1(6/12-week)
- Progression-free survival(6-month)
- Immune-related adverse events(12-week)
- Overall survival(1-year)
- 6-week modified immune-related response rate(6-week)
研究者
Dae Seog Heo
Professor
Seoul National University Hospital
研究点 (1)
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