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.