Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Number of Participants Responding to the Vaccine
研究概览
简要总结
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells.
The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.
详细描述
The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
- •Surgically resected at least 4 weeks ago but not more than 6 months ago
- •Bronchoalveolar carcinomas allowed
- •Completion of any chemotherapy or radiation given in conjunction with Surgery (neoadjuvant or adjuvant)
- •No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of enrollment
- •ECOG performance status of 0 to 2
- •Adequate organ and marrow function defined as follows:
- •Hemoglobin ≥9.0 gm/dL
- •Bilirubin < 2.5 x upper limit of normal
- •AST <2.5 x upper limit of normal
- •ALT <2.5 x upper limit of normal
- •Creatinine <3 mg/dL
- •Women of childbearing potential must have a negative pregnancy test and be willing to use acceptable methods of contraception through week 16.
排除标准
- •Cardiovascular disease defined as:
- •New York Heart Association Class III or IV (Section 19.2) congestive heart failure
- •hemodynamically significant valvular heart disease
- •myocardial infarction within the last six months
- •active angina pectoris
- •uncontrolled ventricular arrhythmias
- •stroke within one year
- •known cerebrovascular disease
- •History of HIV, infectious hepatitis, or chronic immunosuppressive disease
- •concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
- •History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
- •Female patients must not be pregnant or breastfeeding.
- •History of participation in any investigational drug study within 4 weeks preceding initiation of study treatment.
研究组 & 干预措施
1650-G Vaccine
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.
干预措施: 1650-G Vaccine (Drug)
结局指标
主要结局
Number of Participants Responding to the Vaccine
时间窗: 16 weeks after vaccination
The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (\>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (\> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
次要结局
未报告次要终点
研究者
Edward Hirschowitz
Associate Professor of Medicine
University of Kentucky