A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
OncoVAX® is the first cancer therapy that both prevents cancer recurrence and
addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase
IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's
own cancer cells to mobilize the body's immune system to prevent the return of colon
cancer following surgery.
详细描述
OncoVAX is an active specific immunotherapeutic (ASI) stimulating a patient's immune
response to autologous (patient-specific) tumor cells. It is comprised of sterile, live but
non-dividing tumor cells obtained following standard-of-care surgical tumor resection for
Stage II colon cancer. Within 35 days following surgery, patients are immunized with
OncoVAX to prevent disease recurrence, which is incurable and occurs in up to 35% of
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.
- •Patients must have undergone curative resection and have no evidence of residual or metastatic disease.
- •Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.
排除标准
- •Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.
- •Patients with more than one malignant primary colon cancer will be excluded.
研究组 & 干预措施
Surgery
Surgical resection of Stage II colon cancer
干预措施: Surgery (Procedure)
OncoVAX and Surgery
Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
干预措施: Surgery (Procedure)
OncoVAX and Surgery
Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
干预措施: OncoVAX and Surgery (Biological)
结局指标
主要结局
Disease-Free Survival
时间窗: Up to Five years
Defined as time from randomization to the date of the first objective test confirming tumor recurrence or death due to any cause
次要结局
- Recurrence-Free Interval(Up to Five Years)
- Overall Survival(Up to Five Years)