PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma

Basal Cell Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472043
• Other study ID #: PC T308/00
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2007
• Last updated: September 1, 2010
• Start date: October 2000
• Est. completion date: September 2002

Study information

• Verified date: September 2010
• Source: Galderma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

A patient with primary, nodular BCC lesion(s) suitable for entry is defined as a patient with

• Clinically diagnosed primary nodular BCC lesion(s)

• Histologically confirmed diagnosis of BCC

• BCC lesions suitable for simple excision surgery.

• Males or females above 18 years of age.

• Written informed consent

Exclusion Criteria:

A patient that is ineligible for inclusion is a patient fulfilling any of the following criteria:

• Patient with porphyria.

• Patient with Gorlin's syndrome.

• Patient with Xeroderma pigmentosum

• Patients concurrently receiving immunosuppressive medication

• Patients with a history of arsenic exposure.

• Known allergy to Metvix®, a similar PDT compound or excipients of the cream

• Participation in other clinical studies either concurrently or within the last 30 days.

• Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.

• Conditions associated with a risk of poor protocol compliance.

Lesion Exclusion Criteria:

• A nodular BCC lesion in periorbital area, ears and nasolabial fold.

• A nodular BCC lesion with the longest diameter less than 6 mm or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.

• Pigmented nodular BCC lesion(s)

• Morpheaform nodular BCC lesion(s).

• Infiltrating nodular BCC lesion(s).

• Prior treatment of the BCC lesion(s).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Procedure:
• PDT with Metvix 160 mg/g cream and Placebo cream

Locations

Country	Name	City	State
Australia	Dr. Michael Freeman	Benowa	Queensland
Australia	Dept. of Dermatology, Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Department of Dermatology, St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	Dermatology Dept., St. George Hospital	Kogarah	New South Wales
Australia	Dermatology Centre	Liverpool	New South Wales
Australia	Dermatology Dept., Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Galderma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely).		6 months after last treatment
Secondary	Histological and clinical mean patient response rates weighted for the number of lesions within a patient		3 and 6 months after last treatment
Secondary	Histological and clinical number of lesions across patients that show complete response		3 and 6 months after last treatment
Secondary	Clinical complete patient response		3 and 6 months after last treatment
Secondary	Evaluation of cosmetic outcome		3 and 6 months after last treatment
Secondary	Adverse events		2 weeks, 4 weeks and 3 months after each treatment cycle