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
- 4
- 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
- 未提供
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 (4)
Loading locations...
相似试验
已完成
1 期
Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver MetastasesHead and Neck CancerMetastatic CancerColorectal CancerNCT00062348European Organisation for Research and Treatment of Cancer - EORTC27
招募中
3 期
Investigating the Clinical Effects of Boron-based Gel on Restorative Dermatoses and Radiation Traumatic CausesIRCT20190305042925N1Tabriz University of Medical Sciences200
终止
1 期
Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck CancerHead and Neck CancerNCT00927147Boneca Corporation17
终止
2 期
Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic MelanomaMelanoma (Skin)NCT00085059European Organisation for Research and Treatment of Cancer - EORTC4
已完成
1 期
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment Head and Neck TumorsHead and Neck CancerNCT00114790Boneca Corporation30