NCT00004204Unknown2 期
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
Herbert Irving Comprehensive Cancer Center19 个研究点 分布在 1 个国家开始时间: 2000年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 19
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 temozolomide in treating patients who have recurrent or progressive malignant glioma.
详细描述
OBJECTIVES:
- Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
- Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
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 proven recurrent or progressive malignant glioma of one of the following types:
- •Anaplastic oligodendroglioma or oligoastrocytoma
- •Anaplastic astrocytoma
- •Glioblastoma multiforme (stratum closed to accrual 11/30/01)
- •Patients who have failed radiotherapy are eligible
- •Measurable disease by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •SGOT or SGPT less than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)
- •BUN less than 1.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •No other serious concurrent infection or other medical illness that would preclude study entry
- •No frequent vomiting or partial bowel obstruction
- •HIV negative
- •No AIDS-related illness
- •No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent epoetin alfa
- •Chemotherapy:
- •At least 6 weeks since other prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)
- •Recovered from prior surgery
- •No other concurrent investigational agents
- •Concurrent anticonvulsant therapy allowed
排除标准
- 未提供
研究者
研究点 (19)
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