- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472108
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Santa Monica, California, United States, 90404-2115
- Clinical Research Specialists Inc
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Department of Dermatology, University of Minnesota Hospital and Clinic
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Rochester, Minnesota, United States, 55905
- Department of Dermatology, Mayo Medical School, Mayo Clinic
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Associates
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New York
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Buffalo, New York, United States, 14263
- Department of Dermatology, Roswell Park Cancer Institue
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Oregon
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Portland, Oregon, United States, 97210
- Northwest Cutaneous Research Specialists
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Texas
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Austin, Texas, United States, 78759
- Dermresearch, Inc.
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Dallas, Texas, United States, 75230
- Texas Dermatology Research Institute
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Virginia
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Norfolk, Virginia, United States, 230507
- Virginia Clinical Research, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 months after last treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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3 and 6 months after last treatment
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Histological and clinical number of lesions across patients that show complete response
Time Frame: 3 and 6 months after last treatment
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3 and 6 months after last treatment
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Complete patient response
Time Frame: 3 and 6 months after last treatment
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3 and 6 months after last treatment
|
Evaluation of cosmetic outcome.
Time Frame: 3 and 6 months after last treatment
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3 and 6 months after last treatment
|
Adverse events
Time Frame: 2 weeks, 4 weeks and 3 months after each treatment cycle
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2 weeks, 4 weeks and 3 months after each treatment cycle
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Whitney Tope, MPhil, MD, University of Minnesota Hospital and Clinic
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC T307/00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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