Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Metvix® cream
Intervention MeSH terms: Methyl 5-aminolevulinate; Aminolevulinic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Photodynamic therapy (PDT); PDT with Metvix cream; "High risk" BCC; Basal Cell carcinoma; Histologically confirmed complete response

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 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 to
             perform 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 largest
             diameter 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-zone
             according to Swanson) or on the ear In participants with more then 6 eligible lesions,
             the 6 lesions to be treated was randomly chosen.

        Exclusion Criteria:

          -  Prior treatment of the lesion within 4 weeks.

          -  A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by
             histology. 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 a
             negative pregnancy test and use contraception during the treatments and for at least
             one month thereafter).

          -  Conditions associated with a risk of poor protocol compliance.