NCT01052142已完成1 期
A Phase I Open-label Study of the Safety and Immunogenicity of Escalating Doses of Lipovaxin-MM, a Novel Melanoma Immunotherapeutic, in Patients With Metastatic Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with incurable stage IV malignant melanoma for which no standard or curative therapy exist OR patients locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option.
- •Must be able and willing to provide written informed consent.
- •Eastern Cooperative Oncology Group Performance Status of 0 or
- •Life expectancy of ≥12 weeks.
- •Female subjects must be of non-child-bearing potential or using appropriate contraception.
- •Positive test for cell mediated immunity.
排除标准
- •Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks.
- •Previous immunotherapy (except IL-2 or interferon-based therapy) for melanoma.
- •Inadequate bone marrow reserve.
- •Serum bilirubin ≥1.2 times the upper limit of normal.
- •In absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal.
- •If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable.
- •Inadequate renal function.
- •Evidence of severe or uncontrolled systemic diseases.
- •Unresolved toxicity ≥CTC Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
- •Participation in a trial of an investigational agent within the prior 30 days.
- •HIV infection.
- •Immunosuppressive therapy including corticosteroids within 4 weeks of screening.
- •Pregnant or breast-feeding females.
结局指标
主要结局
Adverse events
时间窗: Within 84 days after first dose
Immunogenicity
时间窗: Within 42 days of first dose
antigen specific immune responses will be monitored
次要结局
- Anti-cancer activity (RECIST criteria)(Within 84 days of first dose)
研究者
研究点 (2)
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