NCT01574222终止1 期
Intratumoral Genetic Therapy for Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.
详细描述
Primary
- to determine the safety, toxicity, and Maximum Tolerated Dose (MTD) of autologous dendritic cell-adenovirus chemokine (C-C motif) ligand 21 (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 maximum tolerated dose (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
盲法说明
No masking
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
- •Screening, physical exams, blood draws, CT scans, and follow-up will be performed at VA Greater Los Angeles. All interventional procedures including leukapheresis, CT guided/bronchoscopic biopsies and vaccine injections will be performed at University of California Los Angeles (UCLA).
- •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 refusal of 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 SaO2 at least 90% on room air, PCO2 less than, or equal to 45 mm Hg, or FEV1 greater than 1.0L)
- •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 indication of respiratory failure as defined above
- •Patient 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 less than or equal to 40 OR serum creatinine less than 2 Serum total bilirubin less than or equal to 1.5 OR serum transaminases less than or equal to 2.5 times upper limit of normal (ULN)
- •Negative pregnancy test (if applicable)
- •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 15 days since prior radiotherapy
- •More than 30 days since prior chemotherapy, or non-cytotoxic investigational agents
排除标准
- •Active CNS metastases (i.e., progression of CNS disease during the past 30 days without intervention)
- •Evidence of coagulopathy, defined as PT and/or PTT more than 1.5 times ULN or platelets more than or equal to 100,000/mm
- •Evidence of leukoplakia, defined as absolute neutrophil count more than or equal to 1,500/mm3
- •Evidence of respiratory failure (defined as SaO2 less than 90% on room air, PCO2 more than 45 mm Hg, or FEV1 less than 1.0 L
- •NYHA class III-IV 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 positive
- •Hypersensitivity to any reagents used in the study
- •Signs or sensitivity of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
- •Pregnant or nursing
- •Prior organ allograft
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 28 Days
Toxicity as measured by NCI Common Toxicity Criteria
次要结局
- Disease status at days 28 and 56 days(28 and 56 Days)
研究者
研究点 (2)
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