NCT00003878已完成2 期
The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
New Approaches to Brain Tumor Therapy Consortium22 个研究点 分布在 1 个国家开始时间: 2002年4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
- 22
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. Giving the drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.
详细描述
OBJECTIVES:
- Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant (Gliadel wafers).
- Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment.
- Determine the median, 6-month, 1-year, and 2-year survival of these patients on this regimen.
- Determine the incidence and severity of cognitive function loss of these patients on this regimen.
- Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen.
OUTLINE: Patients receive up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) implanted in the resected tumor cavity.
Patients are followed on day 7 or day of discharge, at 1 month, 3 months, every 3 months for 21 months, and then for survival.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.
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:
- •Supratentorial brain metastases for which surgery is recommended
- •Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR
- •Two brain lesions consistent with metastases on MRI scan
- •Lesions must be accessible through a single craniotomy
- •Metastatic lesions clearly distinct from tumor bed of any benign lesions
- •Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion
- •No prior malignant intracranial neoplasm
- •No lesion(s) in the brainstem
- •No open communication of the resection cavity with the ventricle following resection
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •No concurrent hematologic disorders
- •No concurrent hepatic disease
- •No concurrent renal disease
- •Cardiovascular
- •No concurrent cardiac disease
- •No concurrent pulmonary disorders
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Mini mental score at least 15
- •No known hypersensitivity to carmustine or Gliadel wafers
- •No other serious concurrent medical illness or infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior cranial irradiation
- •See Disease Characteristics
- •No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma)
- •Concurrent systemic therapy allowed
排除标准
- 未提供
研究者
研究点 (22)
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