Calcium Electroporation for Treatment of Cutaneous Metastases

November 1, 2019 updated by: Julie Gehl, Herlev Hospital
The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Department of Oncology, Copenhagen University Hospital, Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Calcium electroporation
Intratumoral injection, once only treatment.
Other Names:
  • Calcium chloride.
  • ATC code: A02AC
  • EV substance code SUB12664MIG
Active Comparator: 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.
Drug: Electrochemotherapy with bleomycin
Intratumoral injection, once only treatment
Other Names:
  • ATC code L01DC01
  • EV substance code SUB00844MIG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: After 6 months
Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.
After 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events to calcium electroporation
Time Frame: After 6 months
Describe adverse events using Common Terminology for Adverse Events, version 4.0
After 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria.
Time Frame: After 6 months
It is a non-inferiority study, and we accept a difference in response on 15%.
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Julie Gehl, Department of Oncology, Copenhagen University Hospital, Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

January 23, 2017

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA1232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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