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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00472043
First received: May 10, 2007
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Basal Cell Carcinoma
Procedure: PDT with Metvix 160 mg/g cream and Placebo cream
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Galderma:

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). [ Time Frame: 6 months after last treatment ]

Secondary Outcome Measures:
  • 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 ]
  • Histological and clinical number of lesions across patients that show complete response [ Time Frame: 3 and 6 months after last treatment ]
  • Clinical complete patient response [ Time Frame: 3 and 6 months after last treatment ]
  • Evaluation of cosmetic outcome [ Time Frame: 3 and 6 months after last treatment ]
  • Adverse events [ Time Frame: 2 weeks, 4 weeks and 3 months after each treatment cycle ]

Enrollment: 66
Study Start Date: October 2000
Study Completion Date: September 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472043

Locations
Australia, New South Wales
Dept. of Dermatology, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Dermatology Dept., St. George Hospital
Kogarah, New South Wales, Australia, 2217
Dermatology Centre
Liverpool, New South Wales, Australia, 2170
Australia, Queensland
Dr. Michael Freeman
Benowa, Queensland, Australia, 4217
Dermatology Dept., Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, Victoria
Department of Dermatology, St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Peter Foley, MD Department of Dermatology, St. Vincent's Hospital Melbourne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00472043     History of Changes
Other Study ID Numbers: PC T308/00
Study First Received: May 10, 2007
Last Updated: September 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Nodular Basal Cell Carcinoma
Basal Cell Carcinoma
Photodynamic therapy (PDT)
Metvix
Histological verification
PDT with Metvix cream
PDT with Placebo cream

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014