PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, there has been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .
In vitro studies of animal and human tissues have shown significant intracellular formation of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive porphyrins induced cytotoxic effects in tumour cells after photoactivation.
The primary objective is to compare PDT with Metvix® cream to PDT with placebo cream in terms of patient complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle.
Secondary objectives are to compare the two treatments in terms of histological and clinical mean patient response weighted by the number of lesions within a patient, lesion response rates across patients, clinical complete patient response, cosmetic outcome and adverse events.
Basal Cell Carcinoma
Procedure: PDT with Metvix 160 mg/g cream and Placebo cream
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma.|
- The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely). [ Time Frame: 6 months after last treatment ]
- Histological and clinical mean patient response rates weighted for the number of lesions within a patient [ Time Frame: 3 and 6 months after last treatment ]
- Histological and clinical number of lesions across patients that show complete response [ Time Frame: 3 and 6 months after last treatment ]
- Clinical complete patient response [ Time Frame: 3 and 6 months after last treatment ]
- Evaluation of cosmetic outcome [ Time Frame: 3 and 6 months after last treatment ]
- Adverse events [ Time Frame: 2 weeks, 4 weeks and 3 months after each treatment cycle ]
|Study Start Date:||October 2000|
|Study Completion Date:||September 2002|
A patient will be randomised to PDT with Metvix® cream or PDT with placebo cream. All eligible BCC lesions within a patient will get the same treatment. All patients will get two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression will be surgically excised. Lesions with partial response (50% or greater reduction on lesion area) will be re-treated, if they do not show complete response three months later they will be surgical excised. Lesions with complete response will be surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens will be histological examined.
|Australia, New South Wales|
|Dept. of Dermatology, Royal Prince Alfred Hospital|
|Camperdown, New South Wales, Australia, 2050|
|Dermatology Dept., St. George Hospital|
|Kogarah, New South Wales, Australia, 2217|
|Liverpool, New South Wales, Australia, 2170|
|Dr. Michael Freeman|
|Benowa, Queensland, Australia, 4217|
|Dermatology Dept., Princess Alexandra Hospital|
|Woolloongabba, Queensland, Australia|
|Department of Dermatology, St. Vincent's Hospital Melbourne|
|Fitzroy, Victoria, Australia, 3065|
|Australia, Western Australia|
|Fremantle, Western Australia, Australia, 6160|
|Principal Investigator:||Peter Foley, MD||Department of Dermatology, St. Vincent's Hospital Melbourne|