NCT00062348已完成1 期
B-Uptake In Different Tumours Using The Boron Compounds BSH And 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 27 人开始时间: 2003年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Boron uptake ratio in tumor vs normal tissue
研究概览
简要总结
RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine whether patients who have thyroid cancer, head and neck cancer, or liver metastases may benefit from boron neutron capture therapy.
PURPOSE: This phase I trial is studying the side effects of giving BPA-F and/or BSH before surgery to detect boron uptake in tissues of patients with primary, metastatic, or recurrent thyroid cancer, head and neck cancer, or liver metastases from colorectal cancer.
详细描述
OBJECTIVES:
- Identify additional solid tumors that may benefit from boron neutron capture therapy.
- Determine the boron concentration in the tumor, surrounding tissues, and blood of patients with operable thyroid cancer, squamous cell cancer of the head and neck, or liver metastases secondary to colorectal adenocarcinoma who receive boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) before surgical resection.
- Determine the feasibility of using these drugs to obtain a favorable absolute boron-10 concentration in the tumor and optimal tumor-to-blood and tumor-to-healthy tissue boron-10 rates in these patients.
- Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients.
OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 3 treatment groups.
- Group I: Patients receive boronophenylalanine-fructose complex (BPA-F) IV over 1 hour. Two hours later, patients undergo surgical resection.
- Group II: Patients receive sodium borocaptate (BSH) IV over 1 hour. Twelve hours later, patients undergo surgical resection.
- Group III: Patients receive BSH IV over 1 hour (administered 12 hours prior to surgery) and BPA-F IV over 1 hour (administered 2 hours prior to surgery). Patients then undergo surgical resection.
During the planned surgery, tissue samples from the tumor and surrounding tissues are collected.
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 or cytologically confirmed solid tumor of 1 of the following malignant tumor types:
- •Squamous cell cancer of the head and neck
- •Thyroid cancer
- •Liver metastases* secondary to colorectal adenocarcinoma NOTE: *Liver metastases are eligible provided colorectal adenocarcinoma has been histopathologically proven and CT scan/MRI shows metastatic lesions in the liver
- •Operable disease for which a surgical excision is planned
- •Primary, metastatic, or locally recurrent disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •AST and ALT no greater than 2.5 times ULN
- •No other severe liver function impairment
- •Creatinine normal
- •BUN normal
- •Cardiovascular
- •No congestive heart failure
- •No angina pectoris
- •No recent coronary artery disease
- •No uncontrolled arrhythmias
- •No conduction defects
- •No other severe heart disease
- •No severe obstructive or restrictive lung disease
- •Gastrointestinal
- •No severe gastrointestinal disease
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No pre-existing serious mental or organic brain disease (e.g., epilepsy)
- •No history of phenylketonuria (only in the case of BPA administration)
- •No severe allergic disease requiring continuous medication
- •No other concurrent severe disease
- •No uncontrolled endocrine disease
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 3 months since prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Boron uptake ratio in tumor vs normal tissue
次要结局
- Toxicity measured by NCI-CTC v2.0 up to 28 days after injections
研究者
研究点 (2)
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