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Calcium Electroporation for Treatment of Cutaneous Metastases

Primary Purpose

Cutaneous Metastases

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Calcium electroporation

Electrochemotherapy with bleomycin

About this trial

This is an interventional treatment trial for Cutaneous Metastases focused on measuring Cutaneous metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Oncology, Copenhagen University Hospital, Herlev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calcium electroporation

Electrochemotherapy with bleomycin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tumor response

Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.

Secondary Outcome Measures

Adverse events to calcium electroporation

Describe adverse events using Common Terminology for Adverse Events, version 4.0

Full Information

NCT ID

NCT01941901

First Posted

September 3, 2013

Last Updated

November 1, 2019

Sponsor

Herlev Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01941901

Brief Title

Calcium Electroporation for Treatment of Cutaneous Metastases

Official Title

Calcium Electroporation for Treatment of Cutaneous Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

January 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herlev Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Metastases

Keywords

Cutaneous metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Patients with cutanoues tumors of any cancer histology were included, and metastases were marked, numbered and photographed. Syringes with either calcium or bleomycin were prepared by a pharmacist, blinded for the treating clinician. After injection of study drug (calcium or bleomycin), electroporation was performed. Metastases were followed and at the 6 month follow-up response was recorded for treated metastases and the actual drug used for each metastasis was revealed.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The patient and treating doctor only knew the size of the treated tumor, and the injection volume, but not the content of the syringe (either calcium or bleomycin).

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calcium electroporation

Arm Type

Experimental

Arm Description

Arm Title

Electrochemotherapy with bleomycin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Calcium electroporation

Other Intervention Name(s)

Calcium chloride., ATC code: A02AC, EV substance code SUB12664MIG

Intervention Description

Intratumoral injection, once only treatment.

Intervention Type

Drug

Intervention Name(s)

Electrochemotherapy with bleomycin

Other Intervention Name(s)

ATC code L01DC01, EV substance code SUB00844MIG

Intervention Description

Intratumoral injection, once only treatment

Primary Outcome Measure Information:

Title

Tumor response

Description

Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.

Time Frame

After 6 months

Secondary Outcome Measure Information:

Title

Adverse events to calcium electroporation

Description

Describe adverse events using Common Terminology for Adverse Events, version 4.0

Time Frame

After 6 months

Other Pre-specified Outcome Measures:

Title

Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria.

Description

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

Time Frame

After 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Gehl

Organizational Affiliation

Department of Oncology, Copenhagen University hospital, Herlev

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Copenhagen University Hospital, Herlev

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28562201

Citation

Falk H, Lambaa S, Johannesen HH, Wooler G, Venzo A, Gehl J. Electrochemotherapy and calcium electroporation inducing a systemic immune response with local and distant remission of tumors in a patient with malignant melanoma - a case report. Acta Oncol. 2017 Aug;56(8):1126-1131. doi: 10.1080/0284186X.2017.1290274. Epub 2017 Feb 22. No abstract available.

Results Reference

background

PubMed Identifier

28816072

Citation

Falk H, Matthiessen LW, Wooler G, Gehl J. Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy. Acta Oncol. 2018 Mar;57(3):311-319. doi: 10.1080/0284186X.2017.1355109. Epub 2017 Aug 17.

Results Reference

result

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Calcium Electroporation for Treatment of Cutaneous Metastases

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