Clinical trial NCT04259658: Histopathologic Effect of Calcium Electroporation on Cancer in the Skin
Official title: Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: calcium
electroporation
tumor infiltrating lymphocytes
cancer
metastases
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.

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.

All 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.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population.
timeFrame: 2 days
Secondary outcomes:
measure: Changes in immune markers
timeFrame: 3 months
measure: Tumour inflammation signature (TIS)
timeFrame: 3 months
measure: Molecular subtype classification
timeFrame: 3 months
measure: Size of lesion
timeFrame: 3 months
measure: TIL population and tumour type
timeFrame: 3 months
measure: Tumour regression
timeFrame: 3 months
measure: Residual tumour
timeFrame: 3 months
measure: Vascular effects
timeFrame: 3 months
measure: Clinical response to intervention
timeFrame: 3 months
measure: Complete response at patient level
timeFrame: 3 months
measure: Complete disappearance of treated lesions (in relation to all lesions treated)
timeFrame: 3 months
measure: Tumour type
timeFrame: 3 months
measure: Systemic immunologic response
timeFrame: 3 months
measure: Importance of previous irradiation
timeFrame: 3 months
measure: Adjacent non-tumour tissue
timeFrame: 3 months
measure: PD-L1 expression over time
timeFrame: 3 months
measure: Relation between change in PD-L1 expression and response
timeFrame: 3 months
measure: PD-L1 expression in relation to cell types
timeFrame: 3 months
measure: PD-L1 expression of different tumour histologies
timeFrame: 3 months
measure: Western blotting
timeFrame: 3 months
measure: Systemic immune factors after calcium electroporation
timeFrame: 3 months
measure: Current measurement
timeFrame: 1 month
measure: PCR
timeFrame: 3 months
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Dept. of Clinical oncology and Palliative Care
Study officials:
affiliation: Zealand University Hospital
name: Julie Gehl, MD
role: PRINCIPAL_INVESTIGATOR
References: