IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma.
PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.
详细描述
OBJECTIVES:
Primary
- Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy.
Secondary
- Determine the overall survival, and response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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
Arm I
Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
干预措施: hydroxyurea (Drug)
Arm I
Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
干预措施: imatinib mesylate (Drug)
Arm II
Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
干预措施: hydroxyurea (Drug)
结局指标
主要结局
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
次要结局
- Survival
- Response rate according to MacDonald criteria
- Toxicity as assessed by NCI CTCAE v. 3.0