Dose Escalating Study for Amphinex-based PCI of Bleomycin.

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 any other investigational therapy or radiotherapy for at least 2 weeks prior to administration of Amphinex at the baseline visit, and have recovered from the acute effects of therapy * Have discontinued cytostatic or cytotoxic therapies with at least 6 half life cycles of the agent prior to administration of Amphinex at the baseline visit * 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.