A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.
PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.
详细描述
OBJECTIVES:
- Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility.
- Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
- Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
- Determine the pharmacokinetics of BPA-f in these patients.
OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT).
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2.
Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.
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:
- •Histologically confirmed glioblastoma multiforme OR
- •Radiographically diagnosed brain metastases after a diagnosis of melanoma
- •Contrast-enhanced tumor volume must not exceed 60 mL
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Not specified
- •Not specified
- •Creatinine normal
- •Cardiovascular:
- •No prior severe cardiac disease, including the following:
- •Uncontrolled arrhythmias or conduction defects
- •Unstable or newly diagnosed angina pectoris
- •Recent coronary artery disease
- •Congestive heart failure
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study
- •No prior phenylketonuria
- •No cognitive impairment that would preclude informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior cranial irradiation
- •Not specified
排除标准
- 未提供