The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Number of CMM participants that respond to IL-2 compared to the number of participants that respond to IL-2 and BCG.
研究概览
简要总结
The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).
详细描述
In the first stage of the study, all consenting CMM patients will be randomized and will receive 4 treatments of either intralesional IL-2 or intralesional IL-2 and BCG. We hypothesize that patients with MM (stage 3C or 4a with a minimum of 4 lesions) that receive combination therapy (IL-2/BCG) in the first stage of treatment will have a higher complete response (iCR) rate compared to IL-2 therapy alone.
Response to stage-one treatment will be monitored and patient response to treatment will be determined and reported according to Immune Response Evaluation Criteria in Solid Tumours (iRECIST) guidelines. Based on response to stage-one treatment, patients will be placed into a response group before entering stage two. For stage two of the trial, patients will be randomized again, and placed into a treatment group; Il-2, IL-2 and BCG, BCG, or Discontinue Treatment. Response to treatment will be monitored and patient response to treatment will be determined and reported according to iRECIST guidelines.
All patients will have lesions biopsied following standard surgical practice techniques and will provide urine and blood for analysis. Tissue samples will be assessed for immune system activity and transcriptome analysis, and urine and blood will be assessed for immune cell populations and markers. All patients will be followed for 5 years post treatment, and patient disease and survival status will be recorded according to iRECIST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cutaneous metastatic melanoma.
- •Has 4 or more melanoma lesions.
- •Between18 and 80 years of age.
排除标准
- •Immunocompromized.
- •Receiving immuno-therapy for other diagnosis.
- •Inflammatory disease.
- •Autoimmune disease.
- •Test positive for TB
结局指标
主要结局
Number of CMM participants that respond to IL-2 compared to the number of participants that respond to IL-2 and BCG.
时间窗: 5 years
The primary outcome measure is the achievement of a superior response rate in patients receiving combination IL-2/BCG treatment compared to patients receiving IL-2 alone. Patient response to treatment will be monitored and patients will be categorized as 1) complete responders, 2) partial responders or 3) stable disease. Data will be analyzed by one-way ANOVA to compare proportion outcomes amongst treatment and response groups.
次要结局
- Number of patients that respond to the addition of BCG in stage two compared to the number of patients respond to continued IL-2 treatment.(5 years)
- Assessment of overall survival in stage one treatment(5 years)
- Assessment of overall survival in stage two treatment(5 years)
- Assessment of Disease Progression Within Stage of Disease: Number of stable and/or new metastasis(5 years)
- Assessment of Metastasis(5 years)
研究者
Carman Giacomantonio
Surgical Oncologist/General Surgeon/Professor
Nova Scotia Health Authority