NCT00066404已完成1 期
A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural cavity may improve the body's ability to fight cancer.
PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating patients who have malignant pleural mesothelioma or malignant pleural effusions.
详细描述
OBJECTIVES:
- Determine the safety and toxicity of intrapleural BG00001 in patients with malignant pleural mesothelioma or malignant pleural effusions.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the success of gene transfer/interferon beta gene expression in patients treated with this drug.
- Determine systemic and intrapleural cytokine responses and cellular and humoral immune response in patients treated with this drug.
- Determine, preliminarily, tumor response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive BG00001 via an intrapleural catheter on day 1.
Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
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:
- •One of the following histologically or cytologically confirmed diagnoses:
- •Malignant pleural mesothelioma
- •Metastatic malignancy to the pleural space
- •Originating from 1 of the following sites:
- •Gastrointestinal organs
- •Genitourinary organs
- •Malignant melanoma
- •Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
- •Measurable or evaluable disease
- •Pleural space involved with tumor accessible for pleural catheter insertion
- •No malignant pleural effusions secondary to lymphoma or sarcoma
- •No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
- •No known brain metastases
- •Previously treated brain metastases with no evidence of active growth are allowed
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hematocrit at least 30% (transfusion allowed)
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 1.5 times ULN
- •Alkaline phosphatase no greater than 1.5 times ULN
- •PT and PTT no greater than 1.5 times normal
- •No end-stage liver disease
- •No chronic active hepatitis B (hepatitis B surface antigen negative)
- •Creatinine no greater than 2.0 mg/dL
- •No end-stage renal disease
- •Cardiovascular
- •No unstable angina
- •FEV_1 greater than 50% of predicted (post-pleural drainage)
- •No severe oxygen-dependent chronic obstructive pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No documented immunodeficiency
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease
- •No other life-threatening illness
- •No known hypersensitivity to any component of study treatment
- •PRIOR CONCURRENT THERAPY:
- 另有 19 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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