Calcium Electroporation for Treatment of Cutaneous Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-01-23

Brief Summary

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

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Detailed Description

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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

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Cutaneous Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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).

Study Groups

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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.

Group Type EXPERIMENTAL

Calcium electroporation

Intervention Type DRUG

Intratumoral injection, once only treatment.

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.

Group Type ACTIVE_COMPARATOR

Electrochemotherapy with bleomycin

Intervention Type DRUG

Intratumoral injection, once only treatment

Interventions

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Calcium electroporation

Intratumoral injection, once only treatment.

Intervention Type DRUG

Electrochemotherapy with bleomycin

Intratumoral injection, once only treatment

Intervention Type DRUG

Other Intervention Names

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Calcium chloride. ATC code: A02AC EV substance code SUB12664MIG ATC code L01DC01 EV substance code SUB00844MIG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No