NCT04225767

Brief Summary

Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Feb 2020

Typical duration for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2.9 years

First QC Date

December 27, 2019

Last Update Submit

December 12, 2022

Conditions

Cancer

Keywords

CalciumElectroporationCancerSkin

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (11)

  • Treatment response up to 12 months (size)

    13 months

  • Assessment of residual tumor from biopsies after 1 year

    12 months

  • MRI scans to verify treatment and evaluate tumour changes after treatment

    2 months

  • Evaluation of patient quality of life before and after treatment using EORTC Questionnaires.

    13 months

  • Systemic immunologic response evaluated by routine scans

    12 months

  • +6 more secondary outcomes

Study Arms (1)

Calcium electroporation treatment

EXPERIMENTAL

Experimental treatment with calcium electroporation for malignant cutaneous and subcutaneous tumours

Combination Product: Calcium electroporation

Interventions

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.

Calcium electroporation treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34135049DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Julie Gehl, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 13, 2020

Study Start

February 18, 2020

Primary Completion

January 1, 2023

Study Completion

August 1, 2023

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)