NCT00003467已完成2 期
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Duke University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 1998年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
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 carmustine in treating adults with recurrent supratentorial low-grade glioma.
详细描述
OBJECTIVES:
- Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
- Assess the toxicity of this therapy in these patients.
OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).
Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.
Patients are followed every 2 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent primary low grade glioma including:
- •Fibrillary astrocytoma
- •Oligodendroglioma
- •Mixed glioma
- •Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hematocrit greater than 29%
- •Absolute neutrophil count greater than 1500/mm^3
- •Platelet count greater than 125,000/mm^3
- •SGOT less than 1.5 times upper limit of normal (ULN)
- •Bilirubin less than 1.5 times ULN
- •Creatinine less than 1.5 mg/dL
- •BUN less than 25 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy unless disease progression
- •Endocrine therapy:
- •Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
- •No concurrent immunosuppressive agents
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy unless disease progression
- •Not specified
- •No other concurrent medication that may interfere with study
排除标准
- 未提供
研究者
研究点 (2)
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