Phase II Clinical Trial of TROGLITAZONE, a Ligand for the Peroxisome Proliferator-Activated Receptor Gamma (PPAR), as Antineoplastic Differentiation Therapy for Patients With Malignant Liposarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
研究概览
简要总结
Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.
详细描述
OBJECTIVES:
I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype.
II. To perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention.
III. To evaluate the tolerance and safety of troglitazone in this patient population.
PROJECTED ACCRUAL:
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 120 Years（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
Troglitazone
Patients received troglitazone 800 mg oral once-daily. Treatment continued as long as patient was responding or in stable disease clinically and ended if patient experienced progression or unacceptable toxicity.
干预措施: troglitazone (Drug)
研究者
George Demetri, M.D.
Demetri, George MD
Dana-Farber Cancer Institute