NCT01233492终止1 期
A Cancer Research UK Pharmacokinetic Study of BPA in Patients With High Grade Glioma to Optimize Uptake Parameters for Clinical Trials of BNCT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pharmacokinetic (PK) parameters used to construct a PK model with the aim of being able to predict boron up-take by tumor and normal brain tissue
研究概览
简要总结
RATIONALE: Giving boron phenylalanine in different ways and measuring it in tissue in patients with glioblastoma multiforme may help in planning better radiation therapy, such as boron neutron capture therapy, for patients in the future.
PURPOSE: This phase I trial is studying the side effects, best dose boron phenylalanine, and best way of giving it with or without mannitol in treating patients with glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- To determine the optimal way to deliver boron phenylalanine (BPA) with or without mannitol in terms of route (intravenous vs intraarterial), blood-brain barrier disruption, and dose for use in subsequent therapeutic trials of boron neutron capture therapy (BNCT) in patients with high-grade glioma.
- To evaluate the toxicity profile of BPA administered intravenously or intra-arterially.
- To evaluate the pharmacokinetic behavior of BPA using samples of blood, urine, tumor tissue, normal brain tissue, extracellular fluid, and cerebrospinal fluid.
Secondary
- To produce indicative treatment plans using BPA administered either intravenously or intra-arterially with or without mannitol to support the design of combination studies using BPA and thermal neutrons for BNCT.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Radiologically and clinically suspected solitary glioblastoma multiforme
- •High-grade disease
- •Agreed to undergo stereotactic biopsy as part of routine diagnostic work-up
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2 (0-1 for patients ≥ 65 years old)
- •Life expectancy > 4 months
- •Hemoglobin ≥ 9.0 g/dL
- •Neutrophil count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Serum bilirubin ≤ 1.5 times upper normal of limit (ULN)
- •AST ≤ 1.5 times ULN
- •Uncorrected EDTA-Isotope creatinine clearance ≥ 40 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use two forms of effective contraception 4 weeks prior to, during, and for 6 months after completion of study therapy
- •Able to cooperate with procedures and follow-up
- •Not at high risk of complications from blood-brain barrier disruption with mannitol on pre-treatment CT scan (an open quadrigeminal plate cistern, absence of dilatation of the contralateral frontal horn, and absence of uncal herniation)
- •No history of uncontrolled seizures
- •No phenylketonuria
- •No current or previous malignancies at sites other than the brain, except for adequately treated cone-biopsied carcinoma in-situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin
- •Not at high medical risk due to nonmalignant systemic disease, including active uncontrolled infection
- •No known hepatitis B, hepatitis C, or HIV positivity by serology
- •No concurrent congestive heart failure, history of NYHA class III-IV cardiac disease, history of myocardial infarction or active ischemic heart disease within the past year, or history of cardiac arrhythmia or thromboembolic disease
- •No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial
- •PRIOR CONCURRENT THERAPY:
- •At least 12 hours since prior and no concurrent steroids
- •At least 48 hours since prior phenylalanine-containing drinks (e.g., colas)
- •At least 48 hours since prior excessive consumption of phenylalanine-containing foods, including any of the following:
- •Low phenylalanine content (e.g., fruit juice, fruits [except bananas], vegetables, and low-protein breads and pastas
- •Medium phenylalanine content (e.g., corn, bread, french fries, potatoes, peas, rice, and regular pasta)
- •High phenylalanine content (e.g., refried beans, chicken, nuts, hamburgers, peanuts, cheese, eggs, pork chops, steak, bananas, and milk)
- •At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered
- •No prior cranial radiotherapy
- •No prior endocrine therapy, immunotherapy, or chemotherapy for the brain tumor
- •No other concurrent anticancer therapy or investigational drugs
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetic (PK) parameters used to construct a PK model with the aim of being able to predict boron up-take by tumor and normal brain tissue
Optimal dose of boron phenylalanine (BPA)
Causality of each adverse event to BPA and grading severity according to NCI CTCAE Version 3.0
次要结局
- Change in mean dose to the planning target volume of greater than 15%, for a constant maximum and mean dose to normal tissue in any treatment cohort of the study
- Establishment of a repository of samples including serum and tumor tissue for future studies using techniques such as proteomics and DNA array
- Change in the intra-nuclear percentage of 10B atoms in any cohort of the study of greater than 20%
研究者
研究点 (2)
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