Autologous Dendritic Cell Vaccines in 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
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.
- Determine the potential clinical efficacy of this vaccine in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical).
Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity.
Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer (NSCLC)
- •Meets 1 of the following stage criteria:
- •Completely resected stage I-IIIB disease
- •Underwent surgical resection > 4 weeks but ≤ 4 years ago
- •Unresectable stage IIIA or IIIB disease AND previously treated with definitive radiotherapy or chemotherapy > 6 weeks ago
- •Bronchoalveolar carcinomas allowed
- •Clinically stable disease by chest x-ray or CT scan within the past 6 weeks
- •No progressive disease
- •No malignant pleural or pericardial effusions
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin ≤ 2.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •No known history of infectious hepatitis
- •Creatinine ≤ 3 mg/dL
- •Ionized calcium ≥ 0.9 mmol/L (may be replaced)
- •Cardiovascular
- •No known New York Heart Association class III-IV congestive heart failure
- •No hemodynamically significant valvular heart disease
- •No myocardial infarction within the past 6 months
- •No active angina pectoris
- •No uncontrolled ventricular arrhythmia
- •No stroke within the past year
- •No known cerebrovascular disease
- •No other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam)
- •Immunologic
- •No known HIV positivity
- •No other immunosuppressive disorders, including chronic disorders
- •Not pregnant
- •Negative pregnancy test
- •Potassium ≥ 3.0 mEq/L (may be replaced)
- •Able to tolerate modest blood volume and electrolyte shifts during leukapheresis
- •No other malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior biologic therapy allowed
- •Other concurrent biologic therapy allowed
- •Chemotherapy
- •See Disease Characteristics
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent steroids during and for 16 weeks after study treatment
- •Radiotherapy
- •See Disease Characteristics
- •No concurrent radiotherapy
- 另有 5 项未显示
排除标准
- 未提供
研究组 & 干预措施
Autologous dendritic cell cancer vaccine
Open label nonrandomized
干预措施: autologous dendritic cell cancer vaccine (Biological)
结局指标
主要结局
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
时间窗: six months post vaccine
Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.
次要结局
- Number of Participants Alive Five Years Post Vaccine(five years post vaccine)
研究者
Edward Hirschowitz
Principal Investigator
University of Kentucky