NCT00085059终止2 期
Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA
European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2004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
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment
研究概览
简要总结
RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue.
PURPOSE: This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma.
- Determine the objective local response in patients treated with this regimen.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of local response and time to local progression in patients treated with this regimen.
- Determine the dose-response relationship at the per-lesion level in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
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 melanoma
- •Metastatic disease
- •Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities
- •Accessible lesion(s) for boron neutron capture therapy (BNCT)
- •No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT
- •Measurable disease by MRI within the past 4 weeks
- •Lesion(s) ≥ 10 mm in diameter
- •Indication for palliative radiotherapy that is intended to be delivered as BNCT
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin ≤ 2.5 times upper limit of normal (ULN)*
- •Transaminases ≤ 2.5 times ULN*
- •Alkaline phosphatase ≤ 2.5 times ULN* NOTE: *Unless due to reversible reaction to antiseizure medication
- •Creatinine ≤ 2.5 times ULN
- •Blood urea nitrogen ≤ 2.5 times ULN
- •Cardiovascular
- •No congestive heart failure
- •No newly diagnosed or unstable angina pectoris
- •No uncontrolled arrhythmias
- •No uncontrolled conduction defects
- •No recent coronary artery disease
- •No other severe heart disease
- •No severe pulmonary disease, including severe obstructive or restrictive lung disease
- •No history of phenylketonuria
- •No severe gastrointestinal disease
- •No active peptic ulcer disease
- •No uncontrolled endocrine disease
- •No pre-existing serious mental or organic brain disease (e.g., epilepsy)
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •Able to travel to the Netherlands via public transportation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunologic or biologic therapy
- •No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim [G-CSF])
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent hormonal therapy
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment
次要结局
- Overall survival as measured every 8 weeks at completion of study treatment
- Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment
- Time to local progression measured every 8 weeks after completion of study treatment
- Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment
- Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment
研究者
研究点 (2)
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