Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473343
• Other study ID #: PC T310/00
• Status: Completed
• Phase: Phase 3
• Start date: September 2000
• Est. completion date: June 2006

Study information

• Verified date: June 2021
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 participants but are inadequate in a small group of participants defined as "high-risk" BCC. In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was 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 was used as the basis for the justification of sample size.

Description:

Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle). The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
• Males or females above 18 years of age.
• Written informed consent. AND

Participants with high risk of surgical complications due to:

• Anticoagulant medication or bleeding disorders
• Cardiac risk factors
• Anaesthetic contraindications
• Poor surgical compliance because of participant refusal, dementia, or inability to perform wound care. OR
• Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:

A large BCC lesion with the largest diameter:

• Equal to or greater than 15 mm on extremities, except below the knees, where largest diameter should be equal to or greater than 10 mm
• Equal to or greater than 20 mm on the trunk
• Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zone according to Swanson) or on the ear In participants with more then 6 eligible lesions, the 6 lesions to be treated was randomly chosen.

Exclusion Criteria:

• Prior treatment of the lesion within 4 weeks.
• A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by histology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
• Participant with porphyria.
• Pigmented lesions.
• Known allergy to Metvix® or a similar compound.
• Participation in another clinical study either concurrently or within the last 30 days
• Participant with Gorlin's syndrome.
• Participant with Xeroderma pigmentosum
• Pregnant or breast-feeding (all women of child-bearing potential must document a negative pregnancy test and use contraception during the treatments and for at least one month thereafter).
• Conditions associated with a risk of poor protocol compliance.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• Metvix® cream

Locations

Country	Name	City	State
Australia	Department of Dermatology, Royal Adelaide Hospital	Adelaide	South Australia
Australia	Dermatology Department, The Queen Elisabeth Hospital	Adelaide	South Australia
Australia	South East Dermatology, The Belmont Specialist Clinic	Carnia	Queensland
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre	Heidelberg	Victoria
Australia	Department of Dermatology, St. George Hospital	Kogarah	New South Wales
Australia	Dermatology Surgery & Laser Centre, The Perth Surgicentre	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle	Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.	3 months after last Metvix PDT cycle, up to 6 months
Secondary	Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle	Complete response was defined as no clinically visible BCC lesions in the treatment area.	3 months after last Metvix PDT cycle, up to 6 months
Secondary	Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle	Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin; good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin; fair: slight to moderate occurrence of scarring, atrophy or induration; poor: extensive occurrence of scarring, atrophy or induration.	3 months after the last metvix PDT cycle, up to 6 months
Secondary	Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle	Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.	3 months after the last metvix PDT cycle, up to 6 months
Secondary	Recurrence Rate in Complete Clearance Group	Recurrence rate in complete clearance(CC) group was analyzed.	12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years
Secondary	Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle	Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.	24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years