CLINICAL TRIALS IN USE OF PHOTODYNAMIC THERAPY FOR SUPRAFRONTAL BRAIN TUMORS

使用光动力疗法治疗额上脑肿瘤的临床试验

• 批准号: 6410208
• 负责人: PAUL MULLER
• 金额: $ 22.84万
• 依托单位: HEALTHONE ALLIANCE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-01-01 至 2001-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6410208
• 关键词: astrocytoma; brain neoplasms; clinical research; combination cancer therapy; confocal scanning microscopy; dosage; drug screening /evaluation; fluorescence microscopy; frontal lobe /cortex; glioblastoma multiforme; human subject; human therapy evaluation; light microscopy; neoplasm /cancer chemotherapy; neoplasm /cancer photoradiation therapy; neoplasm /cancer relapse /recurrence; neoplasm /cancer surgery; outcomes research; photosensitizing agents; porphyrins; prognosis; statistics /biometry

The overarching goal of project #2 is the assessment of the efficiency of porfimer sodium [Photofrin] in the photodynamic therapy of malignant brain tumors. Since brain tumors generally do not metastasize, improved local control should result in improved survival. We have shown Photofrin to have an effect on malignant glial tumors. Project #2 consists of two prospective clinical trials. The first [#1A] is a randomized controlled two arm clinical trail using Photofrin-PDT in newly diagnosed patients with malignant astrocytic tumors [malignant astrocytoma and glioblastoma multiforme] in order to determine whether the addition of Photofrin-PDT to standard surgical treatment[ surgical tumor resection, radiation therapy and chemotherapy] will result in a prolongation of the time to recurrence or progression and an increase in survival. Patients will be [after consent] stratified by treatment center and randomized to a no PDT control group or a high light dose [120 j/cm squared] PDT treatment group. The significance of differences in survival will be determined by the product limit estimate technique. The second is a randomized two arm clinical trial using Photfrin-PDT in recurrent malignant astrocytic tumors in order to ascertain the effect on survival of high light doses in comparison to low light doses. Patients will [after consent] be stratified by treatment center and randomized to a high light dose 120 j/cm squared or a low light dose [40 j/cm squared]. The significance of differences in survival will be determined by the product limit estimate technique. Also, we propose to carry out a number of ancillary measurements which will provide more fundamental information on the photosensitizer and light characteristics of human brain tumors. Photosensitizer measurement such as the uptake, photobleaching and distribution of Photofrin will be monitored, both by in vivo measurements at the time of surgery and PDT irradiation and by ex vivo analysis of tissue samples taken immediately before and after irradiation. Surgical specimens will be analyzed a) by extraction to measure the photosensitizer concentration and b) by confocal fluorescence microscopy, correlated with light microscopy, to assess the microdistribution of photosensitizer in the different tissues.

项目2的总体目标是评估效率 在恶性的光动力疗法中，Porfimer钠[光蛋白] 脑肿瘤。 由于脑肿瘤通常不会转移，因此改善 局部控制应改善生存率。 我们已经显示了 光反蛋白对恶性神经胶质肿瘤有影响。 项目＃2 由两个前瞻性临床试验组成。 第一个[＃1A]是使用随机控制的两只手臂临床步道 新诊断的恶性星形胶质细胞患者的光蛋白-PDT 肿瘤[恶性星形细胞瘤和多形胶质母细胞瘤] 确定是否在标准手术中添加光蛋白-PDT 治疗[手术肿瘤切除，放射治疗和 化学疗法]将导致复发时间的延长 或进展和生存的增加。 患者将[之后 [同意]由治疗中心分层并随机分为无PDT 对照组或高剂量[120 J/cm平方] PDT治疗 团体。 将确定生存差异的重要性 通过产品限制估计技术。 第二个是使用Photfrin-pdt的随机两臂临床试验 复发性恶性星形胶质细胞肿瘤以确定效果 与低剂量相比，高剂量的生存。 患者[同意后]将按治疗中心进行分层 随机分配到高剂量120 J/cm平方或低剂量[40 J/cm平方]。 生存差异的重要性将是 由产品极限估计技术确定。 另外，我们建议进行许多辅助测量 将提供有关光敏剂和的更多基本信息 人脑肿瘤的光特征。 光敏剂 测量，例如吸收，光漂白和分布 光蛋白将通过当时的体内测量进行监测 手术和PDT辐照以及通过组织样品的离体分析 立即在辐照之前和之后拍摄。 手术标本会 可以通过提取来分析a）测量光敏剂 浓度和b）通过共聚焦荧光显微镜，相关 使用光学显微镜，以评估 不同组织中的光敏剂。