Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia
试验速览
- 阶段
- 1 期
- 入组人数
- 21
- 试验地点
- 2
研究概览
简要总结
OBJECTIVES:
I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconi's anemia.
II. Determine the efficacy of this treatment regimen in this patient population.
III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell proliferation and peripheral blood mononuclear cell apoptosis in these patients.
详细描述
PROTOCOL OUTLINE:
This is a dose escalation study.
Patients receive amifostine IV over 3-5 minutes three times a week for three weeks.
Cohorts of 3 patients receive one of three dose levels of amifostine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed weekly for 3 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 2 Years 至 —(Child, 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
