Dose Escalating Study for Amphinex-based PCI of Bleomycin.

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal of this extension study is to further investigate the tolerability and efficacy in a phase I setting in order to see whether lower doses than the initial study dose of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or improved safety and tolerability profile in combination with comparable signs of efficacy.

• 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 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.