NCT00016991已完成2 期
A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.
详细描述
OBJECTIVES:
- Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first relapse.
- Determine the pharmacokinetics and toxicity of this drug in these patients.
- Assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug.
OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 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 glioblastoma multiforme in first relapse
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No other uncontrolled concurrent illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No prior allergic reactions to compounds of similar chemical or biologic composition to ZD 1839
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Ocular inflammation must be fully treated before study entry
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy:
- •Must be on stable dose of steroids for at least 1 week
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •At least 1 week since prior surgery
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
- •No concurrent combination antiretroviral therapy for HIV
- •No concurrent enzyme-inducing anticonvulsant drugs
排除标准
- 未提供
研究者
研究点 (2)
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