NCT00656123已完成1 期
A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
研究概览
简要总结
The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented metastatic colorectal cancer
- •ECOG Performance Status of 0 to 1
- •Adequate organ function as defined by study-specified laboratory tests
- •Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- •Signed informed consent form
- •Life expectance > 12 weeks
排除标准
- •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, or other medical conditions
- •Systemically active steroid use
- •Another investigational product within 28 days prior to receiving study drug
- •Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
- •Chemotherapy, radiation, or biological cancer therapy within 28 days prior to receiving study drug
- •No known history or evidence of CNS metastases < 2 years.
- •Pregnant or lactating
- •Unwilling or unable to comply with study procedures
研究组 & 干预措施
CY and colon GVAX
Experimental
干预措施: cyclophosphamide (Drug)
CY and colon GVAX
Experimental
干预措施: Colon GVAX (Biological)
结局指标
主要结局
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
时间窗: 3.5 years
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject.
次要结局
- Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination(5 years)
研究者
研究点 (1)
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