Calcium Electroporation for Treatment of Cutaneous Metastases

Phase 2

Completed

• Conditions: Cutaneous Metastases
• Interventions: Drug: Calcium electroporation; Drug: Electrochemotherapy with bleomycin

• Registration Number: NCT01941901
• Lead Sponsor: Herlev Hospital

Brief 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%.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Primary Completion: 2016-09
• Study Completion: 2017-01-23
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium electroporation	Calcium electroporation	The metastases will be treated with intratumoral injection of calcium chlorid followed by electrotransfer. It is a once-only treatment. Calcium chlorid concentration: 9mg/ml. Total dose: 0,5ml/cm3 tumor volume.
Electrochemotherapy with bleomycin	Electrochemotherapy with bleomycin	The metastases will be treated with intratumoral injection of bleomycin followed by electrotransfer. It is a once only treatment. bleomycin concentration: 1000 IU/ml. Total dose: o,5 ml/cm3 tumor volume.

Primary Outcome Measures

Name	Time	Method
Tumor response	After 6 months	Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.

Secondary Outcome Measures

Name	Time	Method
Adverse events to calcium electroporation	After 6 months	Describe adverse events using Common Terminology for Adverse Events, version 4.0

Trial Locations

Locations (1)

Department of Oncology, Copenhagen University Hospital, Herlev; 🇩🇰 Herlev, Denmark