Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)
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|ClinicalTrials.gov Identifier: NCT04259658|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : December 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cancer||Combination Product: Calcium electroporation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|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.
|Masking:||None (Open Label)|
|Official Title:||Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)|
|Actual Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||February 1, 2024|
Experimental: Calcium electroporation treatment
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. [ Time Frame: 2 days ]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.
- Changes in immune markers [ Time Frame: 3 months ]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.
- Tumour inflammation signature (TIS) [ Time Frame: 3 months ]Gene expression signatures including the 18-gene TIS will be calculated as a weighted linear average of the constituent genes.
- Molecular subtype classification [ Time Frame: 3 months ]Gene expression profiling according to tumour histology.
- Size of lesion [ Time Frame: 3 months ]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.
- TIL population and tumour type [ Time Frame: 3 months ]To describe any relation between change in TIL population (percentage of cells) and tumour type before and after calcium electroporation.
- Tumour regression [ Time Frame: 3 months ]To describe presence of regressive changes including necrosis at different timepoints (percentage of tissue).
- Residual tumour [ Time Frame: 3 months ]To describe presence of residual tumour (yes/no) and description of topographical location.
- Vascular effects [ Time Frame: 3 months ]To investigate vascular effects of calcium electroporation including changes in capillary structures by histochemical staining for endothelial biomarkers CD31 and/or CD34.
- Clinical response to intervention [ Time Frame: 3 months ]To document evolution of tumours before and after treatment using digital photography including a ruler.
- Complete response at patient level [ Time Frame: 3 months ]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.
- Complete disappearance of treated lesions (in relation to all lesions treated) [ Time Frame: 3 months ]To sum number of lesions across all patients with complete remission after one or two treatments, respectively (expressed at percentage of all treated lesions).
- Tumour type [ Time Frame: 3 months ]To establish number of treated tumours with complete response depending on tumour type.
- Systemic immunologic response [ Time Frame: 3 months ]To detect signs of systemic immunologic response from any routine scans before and after treatment in the inclusion period.
- Importance of previous irradiation [ Time Frame: 3 months ]To investigate differences in effect depending whether the treated tumour was in a previously irradiated area.
- Adjacent non-tumour tissue [ Time Frame: 3 months ]To evaluate effect on adjacent non-tumour tissue.
- PD-L1 expression over time [ Time Frame: 3 months ]To assess PD-L1 expression over time by biopsy.
- Relation between change in PD-L1 expression and response [ Time Frame: 3 months ]To investigate any relation between change in PD-L1 expression and tumour response.
- PD-L1 expression in relation to cell types [ Time Frame: 3 months ]To describe PD-L1 expression in relation to cell types found in the tumour environment
- PD-L1 expression of different tumour histologies [ Time Frame: 3 months ]To describe PD-L1 expression on different cell types of the different tumour histologies investigated.
- Western blotting [ Time Frame: 3 months ]To examine frozen tissues samples by western blotting in order to support any of the above mentioned endpoints.
- Systemic immune factors after calcium electroporation [ Time Frame: 3 months ]Blood samples may be analyzed for NK cell- and T-cell gene expression levels. Levels before and after treatment will be compared.
- Current measurement [ Time Frame: 1 month ]To measure current during treatment as indicated by the pulse generator.
- PCR [ Time Frame: 3 months ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Pregnancy or lactation
- Allergy to local anaesthesia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259658
|Contact: Mille Vissing, MD||0045 email@example.com|
|Contact: Julie Gehl, MDfirstname.lastname@example.org|
|Dept. of Clinical oncology and Palliative Care||Recruiting|
|Contact: Julie Gehl, Professor|
|Principal Investigator:||Julie Gehl, MD||Zealand University Hospital|
|Responsible Party:||Zealand University Hospital|
|Other Study ID Numbers:||
|First Posted:||February 6, 2020 Key Record Dates|
|Last Update Posted:||December 13, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
tumor infiltrating lymphocytes
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs