NCT00356980已完成1 期
A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
研究概览
简要总结
RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may 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 TNF-bound colloidal gold in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) in patients with advanced solid tumors.
- Determine the toxicities of CYT-6091 in these patients.
Secondary
- Determine the pharmacokinetics of CYT-6091 in these patients.
- Evaluate biopsy samples of tumor and adjoining normal tissue for levels of CYT-6091.
- Determine if antitumor effects of CYT-6091 occur in these patients.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
Toxicity
次要结局
- Measurements of CYT-6091 in tumor biopsies
- Pharmacokinetic profile of CYT-6091
- Tumor biopsy histology and gene expression after treatment
- Immunogenicity of CYT-6091
- Electron microscopy of biopsy to determine presence of colloidal gold
- Response of target and nontarget lesions
- Overall response
- Duration of response
- Duration of stable disease
研究者
研究点 (4)
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