Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours

Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours

Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.

This will be a non-randomized phase II trial with the objective of evaluating the clinical response rate of calcium electroporation treatment of malignant tumours of the skin and assessing treatment impact on quality of life. This study will investigate the response rate of calcium electroporation treatment of skin metastases and malignant wounds in a real-world setting, in three different cancer centres in Northern Europe. The centres aim to treat a total of 30 patients with cancer in the skin of any histology. The patients will be treated once and followed with regular examinations for 12 months, starting from first treatment day. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.

The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. A subset of patients will undergo MR scans after treatment and another subset of patients will be interviewed regarding treatment impact on quality of life.

Inclusion Criteria:

• Trial subject ≥ 18 years.
• Trial subject must be able to understand the participant information.
• Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
• The patient must have been offered other relevant standard treatment for their cancer disease.
• The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
• The patient can undergo radiation therapy, provided that the treatment field does not involve treated area.
• Performance status ECOG/WHO ≤2.
• At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
• Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch).
• Signed informed consent.

Exclusion Criteria:

• Pregnancy or lactation