CancerPhase 2CAEP-BNCT04259658
Histopathologic Effect of Calcium Electroporation on Cancer in the Skin
A Phase 2 study testing Calcium electroporation in people with Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Calcium electroporation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2020to 27 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or lactation
- Allergy to local anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)
In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.
Read the 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.
- Conditions
- Cancer
- Being tested
- Calcium electroporation
- Keywords
- calcium, electroporation, tumor infiltrating lymphocytes, cancer, metastases
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium electroporationCombination product
Patients with cutaneous metastases will be treated with calcium electroporation.
| Study group | Role | What they receive |
|---|---|---|
| Calcium electroporation treatment | Experimental | Experimental treatment with calcium electroporation for cutaneous metastases. Receives: Combination Product: Calcium electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (23)
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.
Measured: 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.
Measured: 3 months
Molecular subtype classification
Gene expression profiling according to tumour histology.
Measured: 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.
Measured: 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.
Measured: 3 months
Tumour regression
To describe presence of regressive changes including necrosis at different timepoints (percentage of tissue).
Measured: 3 months
Residual tumour
To describe presence of residual tumour (yes/no) and description of topographical location.
Measured: 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.
Measured: 3 months
Clinical response to intervention
To document evolution of tumours before and after treatment using digital photography including a ruler.
Measured: 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.
Measured: 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).
Measured: 3 months
Tumour type
To establish number of treated tumours with complete response depending on tumour type.
Measured: 3 months
Systemic immunologic response
To detect signs of systemic immunologic response from any routine scans before and after treatment in the inclusion period.
Measured: 3 months
Importance of previous irradiation
To investigate differences in effect depending whether the treated tumour was in a previously irradiated area.
Measured: 3 months
Adjacent non-tumour tissue
To evaluate effect on adjacent non-tumour tissue.
Measured: 3 months
PD-L1 expression over time
To assess PD-L1 expression over time by biopsy.
Measured: 3 months
Relation between change in PD-L1 expression and response
To investigate any relation between change in PD-L1 expression and tumour response.
Measured: 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
Measured: 3 months
PD-L1 expression of different tumour histologies
To describe PD-L1 expression on different cell types of the different tumour histologies investigated.
Measured: 3 months
Western blotting
To examine frozen tissues samples by western blotting in order to support any of the above mentioned endpoints.
Measured: 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.
Measured: 3 months
Current measurement
To measure current during treatment as indicated by the pulse generator.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start20 Apr 2020
- Primary completion19 Oct 2022
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Gehl, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259658
- Sponsor's protocol ID
- REG-114-2019
- Acronym
- CAEP-B
- Status last verified
- Oct 2023
- First submitted
- 21 Jan 2020
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)
- ClinicalTrials.gov ID
- NCT04259658
- Acronym / sponsor ID
- CAEP-B / REG-114-2019
- Conditions
- Cancer
- Keywords
- calcium, electroporation, tumor infiltrating lymphocytes, cancer, metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Calcium electroporation treatment | Experimental | Combination Product: Calcium electroporationExperimental treatment with calcium electroporation for cutaneous metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- Allergy to local anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium electroporationPatients with cutaneous metastases will be treated with calcium electroporation. | Combination product | Calcium electroporation treatment |
Primary outcome
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.
23 secondary outcomes
Changes in immune markers
Time frame: 3 months
Tumour inflammation signature (TIS)
Time frame: 3 months
Molecular subtype classification
Time frame: 3 months
Size of lesion
Time frame: 3 months
TIL population and tumour type
Time frame: 3 months
Tumour regression
Time frame: 3 months
Residual tumour
Time frame: 3 months
Vascular effects
Time frame: 3 months
Clinical response to intervention
Time frame: 3 months
Complete response at patient level
Time frame: 3 months
Complete disappearance of treated lesions (in relation to all lesions treated)
Time frame: 3 months
Tumour type
Time frame: 3 months
Systemic immunologic response
Time frame: 3 months
Importance of previous irradiation
Time frame: 3 months
Adjacent non-tumour tissue
Time frame: 3 months
PD-L1 expression over time
Time frame: 3 months
Relation between change in PD-L1 expression and response
Time frame: 3 months
PD-L1 expression in relation to cell types
Time frame: 3 months
PD-L1 expression of different tumour histologies
Time frame: 3 months
Western blotting
Time frame: 3 months
Systemic immune factors after calcium electroporation
Time frame: 3 months
Current measurement
Time frame: 1 month
PCR
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Gehl, MD principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium electroporation in people with Cancer, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.