A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Safety as measured by NCI common toxicity table at completion of study
研究概览
简要总结
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.
详细描述
OBJECTIVES:
Primary
- Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma.
- Compare, preliminarily, the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
Secondary
- Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
结局指标
主要结局
Safety as measured by NCI common toxicity table at completion of study
Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years
Survival as measured by the Kaplan-Meier method at 5 years
次要结局
未报告次要终点