NCT00039364已完成2 期
Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas
European Organisation for Research and Treatment of Cancer - EORTC20 个研究点 分布在 7 个国家目标入组 112 人开始时间: 2002年3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
- 入组人数
- 112
- 试验地点
- 20
研究概览
简要总结
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of imatinib mesylate (in terms of objective response and progression-free survival at 6 months) in patients with gliomas.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to glioma (glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma).
Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 6 months and then every 3 months thereafter.
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 or cytologically confirmed glioblastoma multiforme
- •Recurrent disease by CT scan or MRI
- •No prior chemotherapy OR
- •No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent disease OR
- •Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma
- •Failed prior radiotherapy
- •No more than 1 prior chemotherapy regimen
- •Failed adjuvant chemotherapy OR
- •Failed first-line chemotherapy
- •At least 1 bidimensionally measurable target lesion
- •At least 2 cm on contrast-enhanced CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine less than 1.7 mg/dL
- •Cardiovascular:
- •Cardiac function normal
- •No ischemic heart disease within the past 6 months
- •Normal 12-lead ECG
- •No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- •No unstable systemic disease
- •No active uncontrolled infection
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent anticancer biologic agents
- •No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Must be on stable or decreasing dose of corticosteroids for at least 2 weeks
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior brain irradiation
- •No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the recurrence is histologically confirmed
- •No concurrent radiotherapy
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (20)
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