Calcium Electroporation for Treatment of Cutaneous Metastases

Herlev Hospital

Status and phase: Completed; Phase 2

Conditions: Cutaneous Metastases

Treatments: Drug: Calcium electroporation; Drug: Electrochemotherapy with bleomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01941901

AA1232

Details and patient eligibility

About

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

Full 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%.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7 participants in 2 patient groups

Calcium electroporation

Experimental group

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.

Treatment:

Drug: Calcium electroporation

Electrochemotherapy with bleomycin

Active Comparator group

Description:

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.

Treatment:

Drug: Electrochemotherapy with bleomycin