Calcium Electroporation for Treatment of Cutaneous Metastases

• Status: Completed
• Trial end date: 2017-01-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herlev Hospital
• Treatments: Bleomycin; Calcium; Calcium, Dietary

Criteria

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.