Calcium Electroporation for Treatment of Cutaneous Metastases

Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months.

It is a non-inferiority study and we accept a difference in response on 15%.

Inclusion criteria

• Age > 18 years.
• Histological confirmed cutaneous metastases of any histology.
• At least 1. cutaneous metastases between 0,5 to 3cm, available to electroporation.
• Patient should have been offered standard treatment.
• At least 2 weeks since chemotherapy or radiotherapy.
• Performance status >2 (ECOG).
• Life expectancy >3 months.
• platelet count > 50 mia/l.
• International Normalized Ratio (INR) <1,2.
• Men and women of reproductive age must use effective contraception during the study.
• Patient should be able to understand participants information.
• Signed, informed consent.

Exclusion criteria

• Previously treatment with bleomycin > 200.000 Units/m2.
• Allergy to bleomycin.
• Clinically significant coagulopathy.
• Pregnancy or lactation.
• Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.