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Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours (CaEP-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225767
Recruitment Status : Active, not recruiting
First Posted : January 13, 2020
Last Update Posted : December 13, 2022
Sponsor:
Collaborators:
Vejle Hospital
University College Absalon
University Hospital Schleswig-Holstein
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
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Brief Summary:
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.

Condition or disease Intervention/treatment Phase
Cancer Combination Product: Calcium electroporation Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Calcium electroporation treatment
Experimental treatment with calcium electroporation for malignant cutaneous and subcutaneous tumours
 Combination Product: Calcium electroporation
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Treatment response up to 12 months (size) [ Time Frame: 13 months ]
    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.

  2. Assessment of residual tumor from biopsies after 1 year [ Time Frame: 12 months ]
    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).

  3. MRI scans to verify treatment and evaluate tumour changes after treatment [ Time Frame: 2 months ]
    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).

  4. Evaluation of patient quality of life before and after treatment using EORTC Questionnaires. [ Time Frame: 13 months ]
    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).

  5. Systemic immunologic response evaluated by routine scans [ Time Frame: 12 months ]
    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.

  6. Response according to tumour histology [ Time Frame: 12 months ]
    To list response rates and response duration according to tumour histology.

  7. Remission [ Time Frame: 12 months ]
    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.

  8. Individual response [ Time Frame: 12 months ]
    To determine rate of response for each individual patient.

  9. Importance of irradiation [ Time Frame: 12 months ]
    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.

  10. Current measurement [ Time Frame: 1 day ]
    To measure current during treatment as measured by the pulse generator.

  11. Evaluation of changes in quality of life through qualitative interview [ Time Frame: 2 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

• Pregnancy or lactation

Contacts and Locations
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Information from the National Library of Medicine

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): NCT04225767


Locations
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Denmark
Zealand University Hospital
Næstved, Region Zealand, Denmark, 4700
Sponsors and Collaborators
Zealand University Hospital
Vejle Hospital
University College Absalon
University Hospital Schleswig-Holstein
Investigators
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Principal Investigator: Julie Gehl, MD Zealand University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04225767    
Other Study ID Numbers: REG-115-2019
First Posted: January 13, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Calcium
Electroporation
Cancer
Skin
Additional relevant MeSH terms:
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Neoplasms
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs