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

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring photochemical internalisation, photosensitiser, cutaneous tumour, sub-cutaneous tumour, dose escalation Read More

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.