Brain Clinical

脑临床

• 批准号: 7280295
• 负责人: PAUL MULLER
• 金额: $ 28.92万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7280295
• 关键词: astrocytes; brain neoplasms; clinical research; clinical trials; dosage; fluorescence microscopy; glioma; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer photoradiation therapy; neoplasm /cancer relapse /recurrence; patient oriented research

The overall goal of project #2 is to improve the survival of patients with malignant primary brain tumors by the use of Photofrin-PDT or by the use of combined fluorescence-guided tumor resection [FGR] and ALA-mediated PDT. Since malignant primary brain tumors rarely metastasize, local tumor control should result in prolongation of survival and a delayed recurrence. Two clinical trials of Photofrin-PDT have been undertaken. Clinical trial #1 is to determine in a randomized two arm clinical study whether the addition of Photofrin-PDT to surgical tumor resection, post-operative "adiation and chemotherapy delays recurrence and increases survival in patients with newly-diagnosed malignant astrocytic tumors. Consented patients were randomized to a no-PDT control group and or to a high light dose [120 J/cm2] PDT group. This trial has now been closed and detailed analysis is in progress. Clinical trial #2 is to determine whether high light dose [120 J/cm2] Photofrin-PDT will delay recurrence and increase survival in comparison to low light dose Photofrin-PDT [40 J/cm2] in patients with recurrent malignant astrocytic tumors. This trial is accruing patients. There is growing evidence that survival is improved by surgically reducing the amount of residual tumor. FGR using ALA [a precursor of protoporphyrin IX, which has a highly selective tumor fluorescence and PDT effect] as the sensitizer is being assessed in European trials using subjective and qualitative intra-operative assessments. In clincical trial #3 we will determine the optimal dose and time of administration of ALA using a quanititative fluorescence detection camera system.

项目＃2的总体目标是通过使用Photofrin-PDT或使用联合荧光引导的肿瘤切除[FGR]和ALA介导的PDT来改善恶性原发性脑肿瘤患者的存活。由于恶性原发性脑肿瘤很少转移，因此局部肿瘤控制应导致生存延长和延迟复发。已经进行了两项光蛋白-PDT的临床试验。临床试验＃1是在随机的两个ARM临床研究中确定是否在手术肿瘤切除中添加光蛋白-PDT是否是否在新近诊断的恶性肿瘤患者中延迟了术后“ Adiation and Adiation and Chemothapic”延迟复发并增加了同意患者的患者。现在已关闭，详细分析正在进行中。 与低光剂量光蛋白-PDT [40 J/CM2]相比，复发性恶性星形胶质细胞肿瘤患者的生存率增加。该试验正在累积患者。越来越多的证据表明，通过手术减少残留肿瘤量来改善生存。使用ALA [原源性IX的前体的FGR，它具有高度选择性的肿瘤荧光和PDT 效应]在使用主观和定性术中评估的欧洲试验中评估敏化剂。在Crincical试验＃3中，我们将使用Quanitative荧光检测摄像头系统确定ALA给药的最佳剂量和时间。