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

Zealand University Hospital

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Combination Product: Calcium electroporation

Study type: Interventional

Funder types: Other

Identifiers

NCT04259658

REG-114-2019

Details and patient eligibility

About

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

Full description

In this non randomized phase II study, we will explore histopathological tumour cell death mechanisms in 24 patients with breast cancer metastases or other cutaneous or subcutaneous malignancy. The primary endpoint of the biopsy study is to evaluate differences in tumour infiltrating lymphocyte (TIL) population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to samples taken on the day of treatment before the calcium electroporation procedure. TIL content in biopsies will be evaluated by pathological examination and specified in percent of cells. Patients will be followed up to 3 months and depending on number of treated tumors, biopsies will be taken at different timepoints after one or two treatments with calcium electroporation. Other analyses will include differences regarding tumour type, immune marker expression levels over time, vascular effects and regressive changes as well as examining changes in systemic immunological markers.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

Calcium electroporation treatment

Experimental group

Description:

Experimental treatment with calcium electroporation for cutaneous metastases.

Treatment:

Combination Product: Calcium electroporation