Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
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. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining carmustine with O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then referred for radiotherapy. Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy
- •Measurable residual disease on a contrast-enhanced MRI or CT scan (for patients with a medical contraindication for MRI) with a baseline scan obtained at the corticosteroid dose the patient is receiving on the day of treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin normal
- •SGOT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •BUN no greater than 25 mg/dL
- •DLCO greater than 75% predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •See Disease Characteristics
- •Concurrent corticosteroids allowed if on stable dose for 3 days before study
- •Radiotherapy
- •See Disease Characteristics
- •No more than 28 days since prior surgical resection or biopsy
排除标准
- 未提供