Calcium Electroporation for Treatment of Cutaneous Metastases

Study Overview
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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.

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%.

Official Title
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Calcium Electroporation for Treatment of Cutaneous Metastases

Conditions
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Cutaneous Metastases

Intervention / Treatment
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* Drug: Calcium electroporation
* Drug: Electrochemotherapy with bleomycin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium electroporation<br>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<br>* Intratumoral injection, once only treatment.<br>* Other names: EV substance code SUB12664MIG;|
| Active Comparator: Electrochemotherapy with bleomycin<br>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<br>* Intratumoral injection, once only treatment<br>* Other names: EV substance code SUB00844MIG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | 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 | Describe adverse events using Common Terminology for Adverse Events, version 4.0 | After 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous metastases