A Molecular Pharmacodynamic Dose-titration Trial of Conjugated Linoleic Acid (CLA; Clarinol®) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To define a tolerable dose of oral CLA, given on a daily schedule, that maximally inhibits S14 expression in adipocytes of patients with advanced solid tumors.
研究概览
简要总结
It has become apparent that many cancers depend on specific fats (lipids) for their continued growth. Conjugated linoleic acid (CLA) is a safe, popular, and well-tolerated dietary supplement that promotes weight loss and loss of fat. CLA was recently shown to block the metabolism (uptake and production) of lipids required for growth of some cancers, resulting in killing of cancer cells. The investigators will conduct a clinical trial to test whether oral CLA blocks metabolism of lipids in patients with advanced cancers. Since the dose of CLA that may do this is not yet known, the investigators will start at a dose of CLA known to be tolerable and effective for weight loss. If this dose does not block lipid metabolism, the investigators will test higher doses in successive groups of patients until the investigators identify an effective dose, unless the investigators find that these higher doses cannot be tolerated. In order to verify that CLA is absorbed, it is necessary to measure CLA levels in blood before and after doses are given. Likewise, in order to verify that CLA blocks lipid metabolism, the investigators will need to obtain small samples of abdominal fat (and, in some patients, samples of tumors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
研究组 & 干预措施
CLA
Open-label dose-titration trial of CLA in patients with advanced, refractory malignancies. oral dose 7.5 g/day 28 day cycle
干预措施: Conjugated Linoleic Acid (Drug)
结局指标
主要结局
To define a tolerable dose of oral CLA, given on a daily schedule, that maximally inhibits S14 expression in adipocytes of patients with advanced solid tumors.
时间窗: 2 years
次要结局
- To document ant tumor activity of CLA, if observed, in this population.(2 years)
- To define the plasma pharmacokinetics of CLA in patients with advanced cancer.(2 years)
- To obtain data on the safety and tolerability of CLA given orally, on a daily schedule to patients with advanced cancer.(2 years)
- To quantify the effects of CLA on S14 expression in tumor tissue, at its recommended phase II dose(2 years)
- To quantify effects of CLA on expression of lipogenic enzymes regulated by S14, lipoprotein lipase, and phospho-akt in adipocytes (and tumor tissue).(2 years)
- To quantify effects of CLA on expression of biomarkers for cellular proliferation, S/G2 phases of cell cycle, and apoptosis in tumor tissue.(2 years)
