Back to resultsPDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
Primary Purpose
Basal Cell Carcinoma
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
PDT with Metvix 160 mg/g cream and Placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Nodular Basal Cell Carcinoma, Basal Cell Carcinoma, Photodynamic therapy (PDT), Metvix, Histological verification, PDT with Metvix cream, PDT with Placebo cream
Eligibility Criteria
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).
Sites / Locations
- Dept. of Dermatology, Royal Prince Alfred Hospital
- Dermatology Dept., St. George Hospital
- Dermatology Centre
- Dr. Michael Freeman
- Dermatology Dept., Princess Alexandra Hospital
- Department of Dermatology, St. Vincent's Hospital Melbourne
- Fremantle Dermatology
Outcomes
Primary Outcome Measures
The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely).
Secondary Outcome Measures
Histological and clinical mean patient response rates weighted for the number of lesions within a patient
Histological and clinical number of lesions across patients that show complete response
Clinical complete patient response
Evaluation of cosmetic outcome
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00472043
Brief Title
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Nodular Basal Cell Carcinoma, Basal Cell Carcinoma, Photodynamic therapy (PDT), Metvix, Histological verification, PDT with Metvix cream, PDT with Placebo cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
PDT with Metvix 160 mg/g cream and Placebo cream
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Histological and clinical number of lesions across patients that show complete response
Time Frame
3 and 6 months after last treatment
Title
Clinical complete patient response
Time Frame
3 and 6 months after last treatment
Title
Evaluation of cosmetic outcome
Time Frame
3 and 6 months after last treatment
Title
Adverse events
Time Frame
2 weeks, 4 weeks and 3 months after each treatment cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Foley, MD
Organizational Affiliation
Department of Dermatology, St. Vincent's Hospital Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Dermatology, Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Dermatology Dept., St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Dermatology Centre
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Dr. Michael Freeman
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Dermatology Dept., Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Department of Dermatology, St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
12. IPD Sharing Statement
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PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
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