NCT00601094已完成1 期
A Phase I Trial of CCL21 Gene Modified Dendritic Cells In Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the safety, toxicity, and maximum tolerated dose (MTD) of autologous dendritic cell-adenovirus CCL21 vaccine administered as an intratumoral injection in treating patients with stage IIIB, IV, or recurrent non-small cell lung cancer.
Secondary
- To determine the biologic and clinical responses to therapy.
- To determine treatment-related toxicity using the NCI Common Toxicity Criteria.
- To identify the MTD.
- To monitor patients for evidence of autologous dendritic cell-adenovirus CCL21 vaccine-induced cytokines and antigen-specific immune responses.
- To detect immune responses to tumor-associated antigens and vector.
- To assess patients for objective signs of tumor regression (RECIST Criteria).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 21 capable of giving informed consent
- •Pathologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IIIB, IV, or recurrent disease
- •Progressive disease despite one or more prior chemotherapy regimens as standard of care OR patient refuses standard chemotherapy
- •Measurable metastatic disease by RECIST guidelines
- •Patients with a major endobronchial lesion in the segmental, lobar, or mainstem bronchus with complete obstruction of the airway may be eligible for bronchoscopic injection provided there is no evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
- •Patients with an endobronchial lesion in the segmental bronchus with variable stenosis (not completely obstructed) and not amenable to standard palliative airway treatments (i.e., laser and stenting) may be eligible for bronchoscopic injection if there is no evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 liters)
- •Patients with bullous disease may undergo CT-guided transthoracic injection provided the targeted tumor has an intended needle path without crossing bullae
- •ECOG performance status 0-2
- •BUN ≤ 40 OR serum creatinine ≤ 2
- •Serum total bilirubin ≤ 1.5 OR serum transaminases ≤ 2.5 times upper limit of normal (ULN)
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •More than 14 days since prior acute therapy for viral, bacterial, or fungal infections
- •More than 30 days since prior and no concurrent corticosteroids
- •More than 30 days since prior radiotherapy, chemotherapy, or noncytotoxic investigational agents
排除标准
- •active CNS metastasis (i.e., progression of CNS disease during the past 30 days without intervention)
- •evidence of coagulopathy, defined as PT and/or PTT ≤ 1.5 times ULN OR platelets ≥ 100,000/mm^3
- •evidence of leukoplakia, defined as absolute neutrophil count ≥ 1,500/mm^3
- •evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
- •NYHA class III-IV cardiac disease within the past year
- •myocardial infarction within the past year
- •comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
- •acute viral, bacterial, or fungal infection that requires specific therapy
- •HIV positivity
- •hypersensitivity to any reagents used in the study
- •signs or symptoms of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
- •prior or concurrent evidence of autoimmune disease
- •pregnant or nursing
- •prior organ allograft
结局指标
主要结局
Maximum tolerated dose
时间窗: 28 days
Toxicity as measured by NCI Common Toxicity Criteria
时间窗: 28 days
次要结局
- Disease status at days 28 and 56(56 days)
- Immune response assessment by antigen-specific IFNγ ELISPOT assays on days 0, 28, and 56(56 days)
研究者
研究点 (4)
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