CancerPhase 2CaEP-RNCT04225767
Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
A Phase 2 study testing Calcium electroporation in people with Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Feb 2020to 1 Aug 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 ≥ 18 years.
- Trial subject must be able to understand the participant information.
- Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
- The patient must have been offered other relevant standard treatment for their cancer disease.
- The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
- The patient can undergo radiation therapy, provided that the treatment field does not involve treated area.
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- Performance status ECOG/WHO ≤2.
- At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.
Read the detailed description
This will be a non-randomized phase II trial with the objective of evaluating the clinical response rate of calcium electroporation treatment of malignant tumours of the skin and assessing treatment impact on quality of life. This study will investigate the response rate of calcium electroporation treatment of skin metastases and malignant wounds in a real-world setting, in three different cancer centres in Northern Europe. The centres aim to treat a total of 30 patients with cancer in the skin of any histology. The patients will be treated once and followed with regular examinations for 12 months, starting from first treatment day. 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.
The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. A subset of patients will undergo MR scans after treatment and another subset of patients will be interviewed regarding treatment impact on quality of life.
- Conditions
- Cancer
- Being tested
- Calcium electroporation
- Keywords
- Calcium, Electroporation, Cancer, Skin
- Medical subject headings
- Neoplasms
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 or subcutaneous malignant tumours will be treated with calcium electroporation, i.e. intratumoral injection of calcium followed by electroporation by electric pulses applied directly to the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Calcium electroporation treatment | Experimental | Experimental treatment with calcium electroporation for malignant cutaneous and subcutaneous tumours Receives: Combination Product: Calcium electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour response (size)
Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
Measured: 2 months
Secondary outcomes (11)
Treatment response up to 12 months (size)
Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
Measured: 13 months
Assessment of residual tumor from biopsies after 1 year
Assess tumour and surrounding tissue response to treatment from biopsies of the treated area after 1 year. Microscopy assessment of histopathological regressive changes (eg. % tumor cells and fibrosis).
Measured: 12 months
MRI scans to verify treatment and evaluate tumour changes after treatment
Assess response after treatment on MRI scans on a subset of patients before and immediately after treatment, as well as after 2 months using diffusion-weighted magnetic resonance imaging (DW-MRI) as a method to monitor electroporated tissue, using the concept of the apparent diffusion coefficient (ADC).
Measured: 2 months
Evaluation of patient quality of life before and after treatment using EORTC Questionnaires.
Evaluate patient quality of life before treatment, after 2 months and after 1 year through EORTC QLQ-C15-PAL Core questionnaires evaluating cancer-related symptoms on a scale from 1-4 (not at all-very much) as well as overall quality of life on a scale from 1-7 (very poor-excellent).
Measured: 13 months
Systemic immunologic response evaluated by routine scans
Investigate any sign of systemic immunologic response from any routine scans (MRI, PET-CT etc.) before and after treatment in the inclusion period by tumor size and TNM stage.
Measured: 12 months
Response according to tumour histology
To list response rates and response duration according to tumour histology.
Measured: 12 months
Remission
To determine complete and partial remissions for all tumours treated. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
Measured: 12 months
Individual response
To determine rate of response for each individual patient.
Measured: 12 months
Importance of irradiation
To investigate response (overall, as well as complete and partial) depending whether the treated tumour was in a previously irradiated area. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
Measured: 12 months
Current measurement
To measure current during treatment as measured by the pulse generator.
Measured: 1 day
Evaluation of changes in quality of life through qualitative interview
Analyses of qualitative interviews (in a subset of patients) performed before- and 2 months after treatment that include measures related to patient experience and impact on quality of life.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start18 Feb 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, University College Absalon, University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- Julie Gehl, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225767
- Sponsor's protocol ID
- REG-115-2019
- Acronym
- CaEP-R
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vissing M, Ploen J, Pervan M, Vestergaard K, Schnefeldt M, Frandsen SK, Rafaelsen SR, Lindhardt CL, Jensen LH, Rody A, Gehl J. Study protocol designed to investigate tumour response to calcium electroporation in cancers affecting the skin: a non-randomised phase II clinical trial. BMJ Open. 2021 Jun 16;11(6):e046779. doi: 10.1136/bmjopen-2020-046779.
PubMed 34135049
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
- ClinicalTrials.gov ID
- NCT04225767
- Acronym / sponsor ID
- CaEP-R / REG-115-2019
- Conditions
- Cancer
- Keywords
- Calcium, Electroporation, Cancer, Skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Vejle Hospital, University College Absalon, University Hospital Schleswig-Holstein
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 13 Jan 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.
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.
Detailed description
This will be a non-randomized phase II trial with the objective of evaluating the clinical response rate of calcium electroporation treatment of malignant tumours of the skin and assessing treatment impact on quality of life. This study will investigate the response rate of calcium electroporation treatment of skin metastases and malignant wounds in a real-world setting, in three different cancer centres in Northern Europe. The centres aim to treat a total of 30 patients with cancer in the skin of any histology. The patients will be treated once and followed with regular examinations for 12 months, starting from first treatment day. 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.
The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. A subset of patients will undergo MR scans after treatment and another subset of patients will be interviewed regarding treatment impact on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium electroporation treatment | Experimental | Combination Product: Calcium electroporationExperimental treatment with calcium electroporation for malignant cutaneous and subcutaneous tumours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Trial subject ≥ 18 years.
- Trial subject must be able to understand the participant information.
- Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
- The patient must have been offered other relevant standard treatment for their cancer disease.
- The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
Key exclusion criteria (1 listed)
- Pregnancy or lactation
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 or subcutaneous malignant tumours will be treated with calcium electroporation, i.e. intratumoral injection of calcium followed by electroporation by electric pulses applied directly to the tumor. | Combination product | Calcium electroporation treatment |
Primary outcome
Tumour response (size)
Time frame: 2 months
Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
11 secondary outcomes
Treatment response up to 12 months (size)
Time frame: 13 months
Assessment of residual tumor from biopsies after 1 year
Time frame: 12 months
MRI scans to verify treatment and evaluate tumour changes after treatment
Time frame: 2 months
Evaluation of patient quality of life before and after treatment using EORTC Questionnaires.
Time frame: 13 months
Systemic immunologic response evaluated by routine scans
Time frame: 12 months
Response according to tumour histology
Time frame: 12 months
Remission
Time frame: 12 months
Individual response
Time frame: 12 months
Importance of irradiation
Time frame: 12 months
Current measurement
Time frame: 1 day
Evaluation of changes in quality of life through qualitative interview
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 34135049Vissing M, Ploen J, Pervan M, Vestergaard K, Schnefeldt M, Frandsen SK, Rafaelsen SR, Lindhardt CL, Jensen LH, Rody A, Gehl J. Study protocol designed to investigate tumour response to calcium electroporation in cancers affecting the skin: a non-randomised phase II clinical trial. BMJ Open. 2021 Jun 16;11(6):e046779. doi: 10.1136/bmjopen-2020-046779.
- 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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?
Results are not available in the source record.
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?
Tumour response (size) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225767, which also lists 1 linked publication.
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 13 Dec 2022.