NCT04225767

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Calcium electroporation	Patients with cutaneous or subcutaneous malignant tumours will be treated with calcium electroporation, i.e. intratumoral injection of calcium followed by electroporation by electric pulses applied directly to the tumor.

Timeline

• Start date: 2020-02-18
• Primary completion: 2023-01-01
• Completion: 2023-08-01
• First posted: 2020-01-13
• Last updated: 2022-12-13

Locations

1 site across 1 country: Denmark