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

Phase 1

• Conditions: Grade 3 anal intraepithelial neoplasia

• Registration Number: EUCTR2007-001581-32-GB
• Lead Sponsor: Joint UCLH & UCL Biomedical Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-16
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this trial is to determine the safety and feasibility of photodynamic therapy, using systemic aminolaevulinic acid, to treat anal intraepithelial neoplasia of the anal canal.;Secondary Objective: The trial also aims to collect information on the efficacy of photodynamic therapy in the treatment of anal intraepithelial neoplasia.;Primary end point(s): The frequency of any adverse events or reactions that have occured.<br>