A Phase II Study of Allogeneic Large Multivalent Immunogen (LMI) Vaccine and IL-2 for the Treatment of Stable Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Disease Response
研究概览
简要总结
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine therapy together with aldesleukin may be a more effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with aldesleukin works in treating women with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of allogeneic large multivalent immunogen (LMI) vaccine and aldesleukin, as defined by clinical benefit rate (percentage of patients demonstrating a complete response, partial response, or disease stabilization as assessed by RECIST criteria), in women with stable metastatic breast cancer.
Secondary
- To measure the immune response in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the 1- and 2-year overall survival rates in patients treated with this regimen.
- To determine the safety profile and toxicity of this regimen in these patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LMI Vaccination + IL-2
Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.
干预措施: allogeneic large multivalent immunogen breast cancer vaccine (Biological)
LMI Vaccination + IL-2
Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.
干预措施: aldesleukin (Biological)
结局指标
主要结局
Disease Response
时间窗: Up to 2 years
Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Immune Response(48 hours)
- Progression-free Survival(Up to 1 year)
- Overall Survival(2 years)