Dose Escalating Study for Amphinex-based PCI of Bleomycin.

Use of Amphinex for the enhancement of Bleomycin at the intracellular target. The photosensitizer Amphinex is activated by Laser Light at 652 nm.

Superficial lesions (cutaneous or subcutaneous) was treated with the laser light after administration of Amphinex and Bleomycin according to time scheduled provided.

Safety and preliminary effect data where evaluated at a lower dose than explored in the preceeding dose escalating study with Amphinex.

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.