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

December 12, 2022 updated by: Zealand University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Zealand
      • Næstved, Region Zealand, Denmark, 4700
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 months
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).
12 months
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).
2 months
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).
13 months
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.
12 months
Response according to tumour histology
Time Frame: 12 months
To list response rates and response duration according to tumour histology.
12 months
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.
12 months
Individual response
Time Frame: 12 months
To determine rate of response for each individual patient.
12 months
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.
12 months
Current measurement
Time Frame: 1 day
To measure current during treatment as measured by the pulse generator.
1 day
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Vejle Hospital
University Hospital Schleswig-Holstein
University College Absalon

Investigators

  • Principal Investigator: Julie Gehl, MD, Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2020

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 27, 2019

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-115-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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