Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)

REG-114-2019

In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.

2020-04-20

2022-10-19

2023-07-27

Completed

Early phase I

17

Inclusion Criteria: * Trial subject must be able to understand the participant information. * Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. * The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.). * The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area. * Performance status ECOG/WHO ≤2 * At least one cutaneous or subcutaneous tumour measuring at least 5 mm. * 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 * Allergy to local anaesthesia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective phase II clinical study: Patients with cutaneous metastases will be recruited at the Department of Oncology, Zealand University Hospital (ZUH). One cohort of 24 patients with respectively disseminated breast cancer or other solid tumour malignancies, will be included. This will be a non-randomized trial.\n\nAll 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.\n\nAll patients will be treated once and patients with over 3 metastases will be offered retreatment of some of their metastases. A maximum of 2 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 3 months, starting from first treatment day.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}

2023-10-03