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

描述(由申请人提供)： 这个项目的总体目标是确定光动力疗法的临床和细胞/分子效应。 在阶段1A-2ACTCL/MF上使用Pc4。CTCL是一种罕见的皮肤恶性肿瘤，发病率不到20万。推测局部应用Pc4后红光治疗早期CTCL/MF是一种安全、可耐受的治疗方法。目的是通过Pc4-PDT治疗和未治疗的对照皮损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对PDT反应的潜在生物标记物，这些标记物可用于优化未来第二阶段和第三阶段临床试验的方案。已知的Pc4的光稳定性将通过评估重复光曝光的好处来利用。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损伤中的Pc4水平。

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.