Calcium electroporation for the treatment of cutaneous metastases.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005704-17-DK

Enrollment

Registered

2013-03-27

Start date

2013-03-27

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering from advanced cancer with cutaneous metastases. MedDRA version: 17.0 Level: LLT Classification code 10040892 Term: Skin metastases System Organ Class: 100000004864

Interventions

Trade Name: Calcium-sandoz and Calciumchlorid SAD Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Calcium Gluconate Other descriptive name: CALCIUM GLUCONATE, ANHYDROUS Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Patients should understand participants information. 3. Histologically confirmed cutaneous metastases of any histology. 4. At least 1. cutaneous metastases, between 0,5 to 3 cm, available to electroporation. 5. Patient should have been offered standard treatment. 6. At least 2 weeks since chemotherapy or radiotherapy. 7. performance status 3 months 9. platelet count >50 mia/l, INR=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. previously treatment with bleomycin > 200.000 Units/m2 2. Allergy to bleomycin. 3. Clinically significant coagulopathy. 4. Pregnancy or lactation. 5. Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate tumorrespons of calcium elctroporation and eletrochemotherapy with intratumoral bleomycin on cutaneous metastases, and compare the effect of the two treatments. ;Secondary Objective: 1. Describe advers events of calcium electroporation using Common Terminology for Adverse Events, version 4.0. 2. Evaluate whether calcium affect the current intensity by electroporation treatments.;Primary end point(s): Evaluate tumorresponse of calcium electroporation and electrochemotherapy with intratumoral bleomycin on cutaneous metastases using RECIST 1.1 -like criteria and compare the effect of the two treatments ;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: Evaluate tumorrespons of calcium elctroporation and eletrochemotherapy with intratumoral bleomycin on cutaneous metastases, and compare the effect of the two treatments. ;Secondary Objective: 1. Describe advers events of calcium electroporation using Common Terminology for Adverse Events, version 4.0. 2. Evaluate whether calcium affect the current intensity by electroporation treatments.;Primary end point(s): Evaluate tumorresponse of calcium electroporation and electrochemotherapy with intratumoral bleomycin on cutaneous metastases using RECIST 1.1 -like criteria and compare the effect of the two treatments ;Timepoint(s) of evaluation of this end point: 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Describe advers events of calcium electroporation using Common Terminology for Adverse Events, version 4.0. 2. Evaluate if calcium affect the current intensity in elektroporation treatments.;Timepoint(s) of evaluation of this end point: 1. 4 weeks 2. 6 months	—

Countries

Denmark

Contacts

Public ContactDepartment of Oncology, Herlev Hosp

Department of Oncology, Herlev Hospital

julie.gehl@regionh.dk004538683868

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026