NCT01941901

Calcium Electroporation for Treatment of Cutaneous Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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%.

Conditions

• Cutaneous Metastases

Interventions

Type	Name	Description
DRUG	Calcium electroporation	Intratumoral injection, once only treatment.
DRUG	Electrochemotherapy with bleomycin	Intratumoral injection, once only treatment

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-09-01
• Completion: 2017-01-23
• First posted: 2013-09-13
• Last updated: 2019-11-05

Locations

1 site across 1 country: Denmark