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.