NCT00005954已完成2 期
Phase II Treatment of Adults With Brain Metastases With Temodar
Duke University2 个研究点 分布在 1 个国家开始时间: 2000年8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
- 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 temozolomide in treating patients who have brain metastases.
详细描述
OBJECTIVES:
- Determine the activity of temozolomide in patients with brain metastases.
- Determine the toxicity of this treatment in these patients.
OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).
Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.
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:
- •Metastatic lesions to the brain
- •Must not require immediate radiotherapy
- •If received prior radiotherapy, must have progressive disease
- •Evaluable disease by CT scan or MRI
- •Neurologically stable
- •PATIENT CHARACTERISTICS:
- •18 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 or SGPT less than 2.5 times ULN
- •Alkaline phosphatase less than 2 times ULN
- •Blood urea nitrogen 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 contraception
- •No other concurrent nonmalignant systemic disease
- •No acute infection requiring treatment with IV antibiotics
- •HIV negative
- •No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent hematopoietic growth factors, including epoetin alfa
- •No other concurrent biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy, unless evidence of disease progression
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression
- •No concurrent radiotherapy
- •At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (2)
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