NCT00006119已完成2 期
Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 试验地点
- 5
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.
详细描述
OBJECTIVES:
- Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma.
- Determine response at 2 years to this regimen in these patients.
- Determine overall and disease free survival of these patients after this regimen.
- Determine quality of life of these patients.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III).
Patients receive oral hydroxyurea daily for 2 years.
Quality of life is assessed before treatment, then every 3 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven progressive meningioma that is not curable by surgery
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Over 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST and ALT no greater than 2 times ULN
- •Alkaline phosphatase no greater than 2 times ULN
- •Creatinine no greater than 2 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after study
- •No other malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Concurrent corticosteroids allowed for control of intracranial pressure
- •Radiotherapy:
- •Prior radiotherapy allowed
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 1 year since prior experimental therapy
排除标准
- 未提供
研究者
研究点 (5)
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