Back to resultsPhotodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
Primary Purpose
Basal Cell Carcinoma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PDT with Metvix 160 mg/g cream
PDT with 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, PDT with Metvix 160 mg/g cream, PDT with placebo cream, Histological verification
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.
- Patients with BCC arising in a previous radiated area
- 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
- Clinical Research Specialists Inc
- Department of Dermatology, University of Minnesota Hospital and Clinic
- Department of Dermatology, Mayo Medical School, Mayo Clinic
- Academic Dermatology Associates
- Department of Dermatology, Roswell Park Cancer Institue
- Northwest Cutaneous Research Specialists
- DermResearch, Inc.
- Texas Dermatology Research Institute
- Virginia Clinical Research, Inc.
Outcomes
Primary Outcome Measures
The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the basal cell carcinoma [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
Complete patient response
Evaluation of cosmetic outcome.
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00472108
Brief Title
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
Official Title
A Multicenter, 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
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 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 photoactive porphyrins levels 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 surgically excised. Lesions with complete response will be surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens will be histologically 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, PDT with Metvix 160 mg/g cream, PDT with placebo cream, Histological verification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
PDT with Metvix 160 mg/g cream
Intervention Type
Procedure
Intervention Name(s)
PDT with 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 basal cell carcinoma [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
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.
Patients with BCC arising in a previous radiated area
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
Whitney Tope, MPhil, MD
Organizational Affiliation
University of Minnesota Hospital and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Specialists Inc
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404-2115
Country
United States
Facility Name
Department of Dermatology, University of Minnesota Hospital and Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Department of Dermatology, Mayo Medical School, Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Department of Dermatology, Roswell Park Cancer Institue
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Northwest Cutaneous Research Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Texas Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
230507
Country
United States
12. IPD Sharing Statement
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Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
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