Metvix PDT in Patients With "High Risk" Basal Cell 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 photoactive porphyrins. 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 .
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers . It is the most common cancer in humans . Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of patients but are inadequate in a small group of patients defined as "high-risk" BCC.
In this particular patient group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of patients who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome will be reduced. Even a partial response is of clinical interest since the remaining tumour will require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.
The variable "complete response" after one or two Metvix treatment cycles will be used as the basis for the justification of sample size. The following hypothesis will be tested:
H0: Complete response rate of Metvix is less or equal to 65 % versus the alternative hypothesis HA: Complete response rate of Metvix is greater than 65 %
Basal Cell Carcinoma
Procedure: Photodynamic therapy with Metvix 160 mg/g cream
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma|
- The primary end-point will be the histologically confirmed complete response rate within a patient (No BCC cells in the biopsy taken 3 months after the last treatment). [ Time Frame: 3 months after last treatment ]
- Safety evaluation during the first 13 weeks or 6 months (if two treatment cycles) after the first Metvix treatment [ Time Frame: 13 weeks or 6 months after first freatment ]
- Cosmetic outcome [ Time Frame: 12, 24, 36, 48 and 60 months after the first treatment ]
- Recurrence rate [ Time Frame: 12, 24, 36, 48 and 60 months after the first treatment ]
|Study Start Date:||September 2000|
|Study Completion Date:||June 2006|
Prospective, open, multicenter study. The high risk BCC lesions will be treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The patients will receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesion that show non-complete response at 3 months will have a second PDT treatment cycle).
The primary end-point will be the histologically confirmed complete response rate within a patient (No BCC cells in the biopsy taken 3 months after the last treatment).
Secondary endpoints are safety evaluation during the first 13 weeks or 6 months (if two treatment cycles) after the first Metvix treatment, cosmetic outcome and recurrence rates 12, 24, 35, 48 and 60 months after the first Metvix treatment.
|Australia, New South Wales|
|Department of Dermatology, St. George Hospital|
|Kogarah, New South Wales, Australia, NSW 2217|
|South East Dermatology, The Belmont Specialist Clinic|
|Carnia, Queensland, Australia, 4152|
|Australia, South Australia|
|Dermatology Department, The Queen Elisabeth Hospital|
|Adelaide, South Australia, Australia, SA 5011|
|Department of Dermatology, Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, SA 5000|
|Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre|
|Heidelberg, Victoria, Australia, VIC 3081|
|Australia, Western Australia|
|Fremantle, Western Australia, Australia, WA 6106|
|Dermatology Surgery & Laser Centre, The Perth Surgicentre|
|Perth, Western Australia, Australia, WA 6151|
|Principal Investigator:||Carl Vinciullo, MD||Dermatology Surgery & Laser Centre, Perth|