Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer

Inclusion Criteria: * Male or female aged 18 years or above who have given written informed consent. * Skin type I- IV according to the Fitzpatrick skin classification (see appendix G). * With a diagnosis of local recurrence or advanced/metastatic, cutaneous or subcutaneous malignancy * Lesion measurement must not be done more than 2 weeks before the beginning of treatment. More than one field with lesion can be illuminated, but care must be taken to avoid overlap of the fields illuminated. * Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy for at least 2 weeks prior to study entry, and have recovered from the acute effects of therapy. * Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see appendix D). * Clinically assessed as eligible for bleomycin chemotherapy. * Have a predicted life expectancy of at least 3 months. * Geographic proximity that allow adequate follow-up. * If female: have had childbearing potential either terminated by surgery, radiation, or menopause or attenuated by the use of an approved contraceptive method during and for 3 months after the trial. * If male: have had reproductive potential either terminated or attenuated by the use of an approved contraceptive method during and for 3 months after the trial. Exclusion Criteria: * Have received prior PCI. * Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site. * Planned surgery in first 28 days after treatment, except for planned surgical removal of the treated lesion. * Planned dentist appointments in first 28 days after treatment. * Anticancer therapy within the first 28 days after treatment. * Therapy with drugs that induce light sensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea, hypoglycemic agents, thiazide diuretics, and griseofulvin) within the first 14 days after treatment. * Co-existing ophthalmic disease likely to require slit-lamp examination within the first 28 days after treatment. * History of hypersensitivity/anaphylactic reactions. * Previous cumulative dose of Bleomycin received over 200 000 IE * Known allergy or sensitivity to photosensitisers. * Known allergy to Cremophor. * Known allergy to bleomycin. * Conditions contraindicated for bleomycin treatment (lung infection, impaired pulmonary function). * Conditions that worsen when exposed to light (including porphyria). * Conditions associated with a risk of poor protocol compliance. * Pregnancy or breastfeeding.