Phase 1 Study of Pc 4 Photodynamic Therapy for Tx of Cutaneous T-Cell Lymphoma

Pc 4 光动力疗法治疗皮肤 T 细胞淋巴瘤 Tx 的一期研究

• 批准号: 8544193
• 负责人: ELMA D BARON
• 金额: $ 20万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2014-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8544193
• 关键词: Phase; Study; Pc; Photodynamic; Therapy

DESCRIPTION (provided by applicant): The overall goal of this project is to determine the clinical and cellular/molecular effects of PDT using Pc 4 on stage 1A-2A CTCL/MF. CTCL is a rare cutaneous malignancy with a prevalence of less than 200,000. It is hypothesized that topically applied Pc 4 followed by red light is a saf and tolerable treatment for early stage CTCL/MF. The aim is to demonstrate both clinical safety and tissue biological effects using skin biopsies of Pc 4-PDT treated versus untreated control lesions. These biopsies will be analyzed at the gene and protein expression level to determine potential biomarkers of response to PDT in CTCL, that can be used to optimize future protocols for Phase 2 and 3 clinical trials. The known photostability of Pc 4 will be utilized by evaluating the benefits of repeated photoexposures. This will be aided by an in vivo imaging device that measures Pc 4 levels in real time in skin lesions through fluorescence spectroscopy.

描述（由申请人提供）： 该项目的总体目标是确定 PDT 的临床和细胞/分子效应 在 1A-2A CTCL/MF 阶段使用 Pc 4。 CTCL 是一种罕见的皮肤恶性肿瘤，患病率低于 20 万。据推测，局部应用 Pc 4 然后红光是早期 CTCL/MF 的安全且可耐受的治疗方法。目的是使用 Pc 4-PDT 治疗与未治疗的对照病变的皮肤活检来证明临床安全性和组织生物学效应。这些活检将在基因和蛋白质表达水平上进行分析，以确定 CTCL 中 PDT 反应的潜在生物标志物，可用于优化未来 2 期和 3 期临床试验的方案。通过评估重复曝光的好处，将利用 Pc 4 已知的光稳定性。这将得到体内成像设备的帮助，该设备通过荧光光谱实时测量皮肤病变中的 Pc 4 水平。