Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
NCT ID: NCT04225767
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
19 participants
INTERVENTIONAL
2020-02-18
2023-08-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Calcium electroporation treatment
Experimental treatment with calcium electroporation for malignant cutaneous and subcutaneous tumours
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
University College Absalon
OTHER
University Hospital Schleswig-Holstein
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Julie Gehl, MD
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Zealand University Hospital
Næstved, Region Sjælland, Denmark
Countries
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References
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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.
Other Identifiers
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REG-115-2019
Identifier Type: -
Identifier Source: org_study_id