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

NCT ID: NCT00473343

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2006-06-30

Brief 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.

Detailed 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).

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metvix® PDT

Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.

Group Type: EXPERIMENTAL

Metvix® cream

Intervention Type: DRUG

Interventions

Metvix® cream

Intervention Type: DRUG

Other Intervention Names

Methyl 5-aminolevulinate hydrochloride

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Principal Investigators

Carl Vinciullo, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Surgery & Laser Centre, Perth

Locations

Department of Dermatology, St. George Hospital

Kogarah, New South Wales, Australia

South East Dermatology, The Belmont Specialist Clinic

Carnia, Queensland, Australia

Department of Dermatology, Royal Adelaide Hospital

Adelaide, South Australia, Australia

Dermatology Department, The Queen Elisabeth Hospital

Adelaide, South Australia, Australia

Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre

Heidelberg, Victoria, Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia

Dermatology Surgery & Laser Centre, The Perth Surgicentre

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

PC T310/00

Identifier Type: -

Identifier Source: org_study_id