NCT00004028已完成1 期
PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 9
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 I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.
详细描述
OBJECTIVES:
- Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma.
OUTLINE: This is a dose escalation study.
All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity.
Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from 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:
- •Pathologically confirmed recurrent malignant glioma for which surgery is indicated
- •Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 8 weeks
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal
- •Creatinine less than 1.5 times normal
- •BUN less than 2.5 times normal
- •Protein no greater than 3 g/dL
- •No gross hematuria
- •No hypersensitivity to nitrosoureas
- •Not pregnant
- •Fertile patients must use effective contraception
- •No concurrent life threatening disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy during first 8 weeks of study
- •Chemotherapy:
- •At least 4 weeks since chemotherapy (6 weeks since nitrosoureas)
- •No concurrent chemotherapy during first 8 weeks of study
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required
- •No concurrent radiotherapy or brachytherapy during first 4 weeks of study
- •Prior cytoreductive surgery for supratentorial brain tumor required
- •Biopsy alone not sufficient
- •No concurrent investigational therapy during first 8 weeks of study
排除标准
- 未提供
研究者
研究点 (9)
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