Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer 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
- Prevention
- 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
- •One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney
- •Above 18 years of age
- •Failure of at least one chemotherapy protocol
- •Clinical performance status of ECOG 0,1
- •Absolute neutrophil count greater than 1000/mm3
- •Serum ALT/AST less than three times the upper limit of normal
- •Serum creatinine less than or equal to 1.6 mg/dl.
- •Must be able to understand and sign the Informed Consent document
排除标准
- •Below 18 years of age
- •Women who are pregnant
- •Life expectancy of less than three months
研究组 & 干预措施
Autologous or Allogeneic tumor cells
Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously.
干预措施: Autologous or Allogeneic tumor cells (Biological)
