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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, cutaneous or sub-cutaneous malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PCI Biotech AS
• Treatments: Bleomycin

Criteria

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.