NCT00003466已完成2 期
Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
Duke University4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 1998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
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Response rate
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: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
详细描述
OBJECTIVES:
- Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
- Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.
OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).
Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.
Patients are followed every 8-12 weeks 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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:
- •Astrocytoma
- •Oligodendroglioma
- •Mixed glioma
- •Optic pathway glioma*
- •Pontine glioma* NOTE: *Biopsy not required
- •Patients with optic pathway glioma must also meet the following criteria:
- •Progressive loss of vision as defined by doubling of octaves
- •Visual acuity loss not explained by other causes
- •Increase in proptosis of greater than 3 mm
- •Increase in diameter of optic nerve of at least 2 mm on neuroimaging
- •Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •4 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT less than 2.5 times ULN
- •Alkaline phosphatase less than 2 times ULN
- •Creatinine less than 1.5 times ULN
- •BUN less than 1.5 times ULN
- •Must be neurologically stable
- •No systemic disease
- •No acute infection requiring IV antibiotics
- •No frequent vomiting
- •No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
- •No other prior or concurrent malignancies except:
- •Surgically cured carcinoma in situ of the cervix
- •Basal or squamous cell skin cancer
- •HIV negative
- •No AIDS-related illness
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent biologic therapy (growth factors or epoetin alfa)
- •Chemotherapy:
- •At least 6 weeks since prior chemotherapy unless evidence of disease progression
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 6 weeks since prior radiotherapy unless evidence of disease progression
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate
Activity of temozolomide
次要结局
未报告次要终点
研究者
研究点 (4)
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