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 AIN

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001581-32-GB

Enrollment

Registered

2007-05-16

Start date

2008-01-22

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grade 3 anal intraepithelial neoplasia

Interventions

Trade Name: Levulan -- for topical dermatological use, not internal use Product Name: 5-aminolaevulinic acid (ALA) Pharmaceutical Form: Granules for oral solution

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026