IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Immune response
研究概览
简要总结
The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma
详细描述
IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HLA A201 + phenotype
- •Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry
- •Age: 21-75 years
- •ECOG performance status 0-1
- •Adequate marrow function
- •Adequate hepatic function
- •Adequate renal function
- •Written informed consent
排除标准
- •Subjects with measureable non-resectable melanoma
- •Subjects who have had chemotherapy less than 4 weeks before starting trial
- •Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial
- •Subjects who received IL2 less than 4 weeks before starting trial
- •Subjects with a baseline LDH greater than 1.1 times the ULN
- •Subjects who are HIV positive
- •Female subjects who are pregnant
- •Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial
- •Subjects who have asthma and/or are on treatment for asthma
- •Subjects with angina pectoris
- •Subjects with congestive heart failure
- •Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis
- •Subjects with active infections including viral hepatitis
- •Subjects with a history of neoplastic disease othe than melanoma within the last 5 years
- •History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.
- •Subjects who present with open wounds
研究组 & 干预措施
IL15-DC Vaccine
Approximately 9 x 10^6 DCs will be injected (subcutaneously)total per vaccination visit. Patients will receive four vaccinations at weeks 0, 4, 8 and 12.At each scheduled vaccination the patient will receive a total of 3 injections, i.e., 3 mL injections at each of 3 anatomical locations.Injection sites are in upper and lower extremities. Subsequent DC injections will be rotated to different locations on the upper and lower extremities.
干预措施: IL15-DC Vaccine (Biological)
结局指标
主要结局
Immune response
时间窗: 14 weeks
次要结局
- Quality of elicited melanoma specific CD8+ T cells(14 weeks)
- Breadth of melanoma specific immunity(24 weeks)
- Longevity of melanoma specific CD8+ T cell immunity(24 weeks)