Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight non-small cell lung cancer.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.
详细描述
OBJECTIVES:
- Evaluate the safety of multiple endobronchial treatments with adenovirus p53 bronchoalveolar lavage of a single lobe of the lung in patients with bronchoalveolar cell lung carcinoma.
- Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal tissues exposed to the virus in these patients.
- Evaluate whether transbronchial administration of adenovirus p53 results in improved local tumor control in these patients.
OUTLINE: This is a dose escalation study.
Patients undergo biopsy and receive adenovirus p53 by bronchoalveolar lavage on days 1 and 15. Patients repeat biopsy on days 3 and 28. If there is evidence of clinical benefit or response without significant toxicity, patients may receive a maximum of 3 courses. Treatment beyond 3 courses must be approved by protocol investigator.
Cohorts of 3 patients are treated at escalating dose levels of adenovirus p53. Patients in each cohort are followed for dose limiting toxicity (DLT) for 2 weeks after completion of one course before dose escalation proceeds in subsequent cohorts. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 2 additional patients are entered at the same dose level. If more than 1 of 5 patients experience DLT, the previous dose is the maximum tolerated dose (MTD). An additional 10 patients are treated at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed unresectable non-small cell lung cancer with a growth pattern allowing access to the majority of tumor cells via the airway (e.g., bronchioloalveolar or papillary adenocarcinoma)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3
- •Prothrombin time and partial thromboplastin time normal
- •Bilirubin less than 1.5 mg/dL
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •Room air oxygen saturation greater than 90%
- •FEV1 greater than 1.0 L pCO2 less than 50
- •HIV negative
- •No active systemic viral, bacterial, or fungal infections requiring treatment
- •No concurrent illness requiring hospitalization or intravenous medication
- •Not pregnant or nursing
- •Effective contraception required of all fertile patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior adenovirus gene therapy
- •At least 2 weeks since any systemic biologic therapy including prior biologic response modifiers and recovered
- •Chemotherapy:
- •At least 2 weeks since any prior systemic chemotherapy and recovered
- •Endocrine therapy:
- •Recovered from any prior endocrine therapy
- •Radiotherapy:
- •Recovered from any prior radiotherapy
- •At least 2 weeks since any surgical procedure requiring anesthesia
- •At least 4 weeks since prior surgical resection of lung tissues
- •No other concurrent therapy
排除标准
- 未提供