A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 5
- 主要终点
- Overall median survival
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.
详细描述
OBJECTIVES:
- Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide.
- Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen.
- Determine the cause of death of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed extracranial primary malignancy or brain metastases
- •At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI
- •No evidence of spinal drop metastases or spread to noncontiguous meninges
- •No lymphoma, small cell lung cancer, or germ cell tumor
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 4 months
- •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 mg/dL
- •SGPT and/or SGOT no greater than 2 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •BUN no greater than 25 mg/dL
- •Able to be regularly followed
- •No sensory neuropathy greater than grade 2
- •No other major medical illnesses that would preclude study
- •No neurologic or psychiatric impairments that would preclude study
- •No active infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No other concurrent chemotherapy during and for 4 weeks after study
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to head or neck
- •No prior stereotactic radiosurgery
- •Concurrent radiotherapy to extracranial sites of underlying malignancy allowed
- •Prior craniotomy allowed if completed within the past 10-28 days
排除标准
- 未提供
结局指标
主要结局
Overall median survival
次要结局
- Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter
- Median time to tumor progression
- Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter
- Median time to neurologic response and progression
- Cause of death at median time
- Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days