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.