Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 65
- 主要终点
- Response to suramin
研究概览
简要总结
RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing.
PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.
详细描述
OBJECTIVES: I. Assess the response of patients with adrenocortical carcinoma treated with suramin. II. Evaluate the qualitative and quantitative toxic effects of this therapy.
OUTLINE: Patients are described according to stage, performance status, prior radiotherapy, prior surgery, and prior mitotane therapy. Patients receive suramin IV for 5 days in the first week, then twice a week for 2 weeks, and then weekly for a total of 12 weeks. Hydrocortisone is taken PO twice daily. Following a 12 week rest, patients receive a second course; those with stable or responding disease continue treatment for a maximum of four courses.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued at a rate of 6-7 per year.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Suramin
干预措施: suramin (Drug)
Suramin
干预措施: therapeutic hydrocortisone (Drug)
结局指标
主要结局
Response to suramin
时间窗: From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles
次要结局
- Number and grade of adverse events(From date of registration until progression or date of death from any cause, whichever came first, up to four cycles)