Clinical trial NCT04225767: Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
Official title: Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer
Keywords: Calcium
Electroporation
Cancer
Skin
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: University College Absalon
name: University Hospital Schleswig-Holstein
First posted: 2020-01-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Tumour response (size)
timeFrame: 2 months
Secondary outcomes:
measure: Treatment response up to 12 months (size)
timeFrame: 13 months
measure: Assessment of residual tumor from biopsies after 1 year
timeFrame: 12 months
measure: MRI scans to verify treatment and evaluate tumour changes after treatment
timeFrame: 2 months
measure: Evaluation of patient quality of life before and after treatment using EORTC Questionnaires.
timeFrame: 13 months
measure: Systemic immunologic response evaluated by routine scans
timeFrame: 12 months
measure: Response according to tumour histology
timeFrame: 12 months
measure: Remission
timeFrame: 12 months
measure: Individual response
timeFrame: 12 months
measure: Importance of irradiation
timeFrame: 12 months
measure: Current measurement
timeFrame: 1 day
measure: Evaluation of changes in quality of life through qualitative interview
timeFrame: 2 months
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Zealand University Hospital
state: Region Zealand
Study officials:
affiliation: Zealand University Hospital
name: Julie Gehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.