NCT00104767已完成1 期
A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the optimal biologic dose (OBD) of celecoxib that is necessary to decrease peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the OBD of this drug that is necessary to decrease peripheral blood lymphocyte FOXP3 levels in these patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer
- •Stage IIIB or IV disease
- •Radiographically measurable disease
- •18 and over
- •Performance status: ECOG 0-2
- •Renal: Creatinine ≤ 2 mg/dL
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •More than 4 weeks since prior chemotherapy
- •Endocrine therapy: More than 4 weeks since prior corticosteroids; No concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids
- •Radiotherapy: More than 4 weeks since prior radiotherapy
- •More than 4 weeks since other prior anticancer therapy
- •More than 4 weeks since prior non-cytotoxic investigational agents
- •At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
排除标准
- •pregnant or nursing
- •comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements
- •hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
- •history of gastrointestinal ulceration, bleeding, or perforation
- •other concurrent cyclooxygenase-2 or -3 inhibitors
- •other concurrent NSAIDs
研究组 & 干预措施
celecoxib
Experimental
干预措施: celecoxib (Drug)
结局指标
主要结局
Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week
时间窗: 7 days
次要结局
- OBD necessary to decrease PBL FOXP3 levels at 1 week(7 dayd)
- Function of CD4+ and CD25+ T-regulatory cells at 1 week(7 days)
- Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week(7 days)
研究者
研究点 (1)
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