Phase I trial of photodynamic therapy using systemic 5-aminolaevulinic acid for the treatment of grade 3 anal intraepithelial neoplasia. - PDT using ALA for the treatment of Grade 3 AI

Joint UCLH & UCL Biomedical Research Unit0 个研究点目标入组 12 人开始时间: 2007年5月16日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Patients with biopsy-proven grade 3 AIN of the anal canal, with or without involvement of the perianal skin, with no evidence of invasive cancer.
•2. Males and non-pregnant females over the age of 18 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Presence of invasive carcinoma of the anus.
•2. History of severe cardiovascular disease, severe angina, congestive heart failure, or recent syncope of cardiovascular origin.
•3. Patients presenting with abnormal cardiac signs or symtoms and signs of congestive heart failure on physical examination.
•4. Patients with orthostatic hypotension resistant to hydration.
•5. Patients who have a history of porphyria, or hypersensitivity to porphyrins.
•6. Patients taking depot preparations of psychotropic medication.
•7. Patients with a white cell count < 2x10e9/L.
•8. Patients with a CD4 count < 200 cells/cubic mm.
•9. Patients with a platelet count < 50x10e9/L.
•10. Patients with a prothrombin time of > 1.5 times the upper limit of normal.
•11. Patients with impaired renal and/or hepatic function at the time of entry into the study.
•12. Patients receiving concurrent chemotherapy, or radiation therapy or chemotherapy within 4 weeks of entry into the study.

发起方

Joint UCLH & UCL Biomedical Research Unit