A Phase 2 interventional study of Calcium electroporation in Cancer, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Zealand University Hospital · Phase 2, Interventional, and Treatment
In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.
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.
Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Experimental treatment with calcium electroporation for cutaneous metastases.
Combination Product: Calcium electroporation
Patients with cutaneous metastases will be treated with calcium electroporation.
The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population.
The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment (biopsy taken on the day of treatment before the calcium electroporation procedure). TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.
Time frame: 2 days
Changes in immune markers
Protein expression levels of immune markers e.g. markers for the innate and adaptive immune system and markers of the STING pathway compared from before treatment and at different timepoints up to 3 months.
Time frame: 3 months
Tumour inflammation signature (TIS)
Gene expression signatures including the 18-gene TIS will be calculated as a weighted linear average of the constituent genes.
Time frame: 3 months
Molecular subtype classification
Gene expression profiling according to tumour histology.
Time frame: 3 months
Size of lesion
To clinically measure changes in lesion size 1, 2 and 3 months after treatment using caliper measurement. Changes in size due to biopsies will be accounted for.
Time frame: 3 months
TIL population and tumour type
To describe any relation between change in TIL population (percentage of cells) and tumour type before and after calcium electroporation.
Time frame: 3 months
Tumour regression
To describe presence of regressive changes including necrosis at different timepoints (percentage of tissue).
Time frame: 3 months
Residual tumour
To describe presence of residual tumour (yes/no) and description of topographical location.
Time frame: 3 months
Vascular effects
To investigate vascular effects of calcium electroporation including changes in capillary structures by histochemical staining for endothelial biomarkers CD31 and/or CD34.
Time frame: 3 months
Clinical response to intervention
To document evolution of tumours before and after treatment using digital photography including a ruler.
Time frame: 3 months
Complete response at patient level
To sum number of patients with complete response after one or two treatments, respectively. Complete response will be defined as disappearance of all target lesions.
Time frame: 3 months
Complete disappearance of treated lesions (in relation to all lesions treated)
To sum number of lesions across all patients with complete remission after one or two treatments, respectively (expressed at percentage of all treated lesions).
Time frame: 3 months
Tumour type
To establish number of treated tumours with complete response depending on tumour type.
Time frame: 3 months
Systemic immunologic response
To detect signs of systemic immunologic response from any routine scans before and after treatment in the inclusion period.
Time frame: 3 months
Importance of previous irradiation
To investigate differences in effect depending whether the treated tumour was in a previously irradiated area.
Time frame: 3 months
Adjacent non-tumour tissue
To evaluate effect on adjacent non-tumour tissue.
Time frame: 3 months
PD-L1 expression over time
To assess PD-L1 expression over time by biopsy.
Time frame: 3 months
Relation between change in PD-L1 expression and response
To investigate any relation between change in PD-L1 expression and tumour response.
Time frame: 3 months
PD-L1 expression in relation to cell types
To describe PD-L1 expression in relation to cell types found in the tumour environment
Time frame: 3 months
PD-L1 expression of different tumour histologies
To describe PD-L1 expression on different cell types of the different tumour histologies investigated.
Time frame: 3 months
Western blotting
To examine frozen tissues samples by western blotting in order to support any of the above mentioned endpoints.
Time frame: 3 months
Systemic immune factors after calcium electroporation
Blood samples may be analyzed for NK cell- and T-cell gene expression levels. Levels before and after treatment will be compared.
Time frame: 3 months
Current measurement
To measure current during treatment as indicated by the pulse generator.
Time frame: 1 month
PCR
To examine frozen tissues samples by PCR. Relevant gene expression will be compared before and after treatment in breast cancer and non breast cancer samples.
Time frame: 3 months
Plan to share: No
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Zealand University Hospital