NCT00059800已完成2 期
A Phase II Trial For Neutron Capture Therapy In Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
- 主要终点
- Clinical response
研究概览
简要总结
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.
详细描述
OBJECTIVES:
- Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy.
- Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen.
- Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc).
Patients undergo boron neutron capture therapy.
Patients are followed for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 melanoma
- •Evaluable disease
- •Lesion(s) to be irradiated must be located in 1 of the following areas:
- •On an extremity
- •On the head or neck (including the scalp)
- •In the subdermal lymphatics (excluding the proximal axilla)
- •Area to be irradiated must not exceed a maximum dimension of 10 cm
- •Maximum tumor depth from the surface of the skin cannot exceed 6 cm
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •Not specified
- •Not specified
- •Creatinine normal
- •Cardiovascular
- •No history of severe cardiac disease
- •No uncontrolled arrhythmias or conduction defects
- •No unstable or newly diagnosed angina pectoris
- •No recent coronary artery disease
- •No congestive heart failure
- •Not pregnant
- •Negative pregnancy test
- •No history of phenylketonuria
- •Must have sufficient mental competence
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to study sites
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Clinical response
Time course, uniformity, and severity of acute dermal reactions
Late dermal reaction after at least six months
Pharmacokinetics
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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