Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma

Last updated: April 8, 2022
Sponsor: Galderma R&D
Overall Status: Completed

Phase

3

Condition

Carcinoma

Basal Cell Carcinoma

Warts

Treatment

N/A

Clinical Study ID

NCT00473343
PC T310/00
  • Ages > 18
  • All Genders

Study 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 photoactive porphyrins. 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 .

BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC.

In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.

The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
  • Males or females above 18 years of age.
  • Written informed consent. AND Participants with high risk of surgical complications due to:
  • Anticoagulant medication or bleeding disorders
  • Cardiac risk factors
  • Anaesthetic contraindications
  • Poor surgical compliance because of participant refusal, dementia, or inability toperform wound care. OR

• Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as: A large BCC lesion with the largest diameter:

  • Equal to or greater than 15 mm on extremities, except below the knees, where largestdiameter should be equal to or greater than 10 mm
  • Equal to or greater than 20 mm on the trunk
  • Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zoneaccording to Swanson) or on the ear In participants with more then 6 eligible lesions,the 6 lesions to be treated was randomly chosen.

Exclusion

Exclusion Criteria:

  • Prior treatment of the lesion within 4 weeks.
  • A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or byhistology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
  • Participant with porphyria.
  • Pigmented lesions.
  • Known allergy to Metvix® or a similar compound.
  • Participation in another clinical study either concurrently or within the last 30 days
  • Participant with Gorlin's syndrome.
  • Participant with Xeroderma pigmentosum
  • Pregnant or breast-feeding (all women of child-bearing potential must document anegative pregnancy test and use contraception during the treatments and for at leastone month thereafter).
  • Conditions associated with a risk of poor protocol compliance.

Study Design

Total Participants: 102
Study Start date:
September 01, 2000
Estimated Completion Date:
June 30, 2006

Study Description

Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).

The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).

Connect with a study center

  • Department of Dermatology, St. George Hospital

    Kogarah, New South Wales NSW 2217
    Australia

    Site Not Available

  • South East Dermatology, The Belmont Specialist Clinic

    Carnia, Queensland 4152
    Australia

    Site Not Available

  • Department of Dermatology, Royal Adelaide Hospital

    Adelaide, South Australia SA 5000
    Australia

    Site Not Available

  • Dermatology Department, The Queen Elisabeth Hospital

    Adelaide, South Australia SA 5011
    Australia

    Site Not Available

  • Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre

    Heidelberg, Victoria VIC 3081
    Australia

    Site Not Available

  • Fremantle Dermatology

    Fremantle, Western Australia WA 6106
    Australia

    Site Not Available

  • Dermatology Surgery & Laser Centre, The Perth Surgicentre

    Perth, Western Australia WA 6151
    Australia

    Site Not Available

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