Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes and Dendritic Cell Vaccination
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Clinical Response (Complete Response + Partial Response)
研究概览
简要总结
RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine if the administration of anti-p53 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes, high-dose aldesleukin, and adenovirus p53 dendritic cell (DC) vaccine after a nonmyeloablative, but lymphoid-depleting, preparative regimen will result in clinical tumor regression in patients with metastatic cancer that overexpresses p53.
Secondary
- Determine the in vivo survival of T-cell receptor (TCR) gene-engineered cells.
- Determine the ability of a dendritic cell (DC) vaccine to restimulate TCR gene-engineered cells in vivo.
- Determine the toxicity profile of this treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: aldesleukin (Biological)
anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: anti-p53 T-cell receptor-transduced peripheral blood lymphocytes (Biological)
anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: autologous dendritic cell-adenovirus p53 vaccine (Biological)
anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: filgrastim (Biological)
anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: cyclophosphamide (Drug)
anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC
Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: fludarabine phosphate (Drug)
anti-p53 TCR PBL + DC + IL-2: Other histology
Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: aldesleukin (Biological)
anti-p53 TCR PBL + DC + IL-2: Other histology
Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: anti-p53 T-cell receptor-transduced peripheral blood lymphocytes (Biological)
anti-p53 TCR PBL + DC + IL-2: Other histology
Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: autologous dendritic cell-adenovirus p53 vaccine (Biological)
anti-p53 TCR PBL + DC + IL-2: Other histology
Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: filgrastim (Biological)
anti-p53 TCR PBL + DC + IL-2: Other histology
Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: cyclophosphamide (Drug)
anti-p53 TCR PBL + DC + IL-2: Other histology
Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
干预措施: fludarabine phosphate (Drug)
结局指标
主要结局
Clinical Response (Complete Response + Partial Response)
时间窗: 5 months
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.
次要结局
- Number of Participants With Adverse Events(5 months)
研究者
Steven Rosenberg, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)