Clinical trial NCT01941901: Calcium Electroporation for Treatment of Cutaneous Metastases
Official title: Calcium Electroporation for Treatment of Cutaneous Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Metastases
Keywords: Cutaneous metastases
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with cutanoues tumors of any cancer histology were included, and metastases were marked, numbered and photographed. Syringes with either calcium or bleomycin were prepared by a pharmacist, blinded for the treating clinician. After injection of study drug (calcium or bleomycin), electroporation was performed. Metastases were followed and at the 6 month follow-up response was recorded for treated metastases and the actual drug used for each metastasis was revealed.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.

Detailed description: Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months.

It is a non-inferiority study and we accept a difference in response on 15%.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Histological confirmed cutaneous metastases of any histology.
* At least 1. cutaneous metastases between 0,5 to 3cm, available to electroporation.
* Patient should have been offered standard treatment.
* At least 2 weeks since chemotherapy or radiotherapy.
* Performance status \>2 (ECOG).
* Life expectancy \>3 months.
* platelet count \> 50 mia/l.
* International Normalized Ratio (INR) \<1,2.
* Men and women of reproductive age must use effective contraception during the study.
* Patient should be able to understand participants information.
* Signed, informed consent.

Exclusion Criteria:

* Previously treatment with bleomycin \> 200.000 Units/m2.
* Allergy to bleomycin.
* Clinically significant coagulopathy.
* Pregnancy or lactation.
* Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

Primary outcomes:
measure: Tumor response
timeFrame: After 6 months
Secondary outcomes:
measure: Adverse events to calcium electroporation
timeFrame: After 6 months
Other outcomes:
measure: Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria.
timeFrame: After 6 months
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University Hospital, Herlev
Study officials:
affiliation: Department of Oncology, Copenhagen University hospital, Herlev
name: Julie Gehl
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falk H, Lambaa S, Johannesen HH, Wooler G, Venzo A, Gehl J. Electrochemotherapy and calcium electroporation inducing a systemic immune response with local and distant remission of tumors in a patient with malignant melanoma - a case report. Acta Oncol. 2017 Aug;56(8):1126-1131. doi: 10.1080/0284186X.2017.1290274. Epub 2017 Feb 22. No abstract available.
citation: Falk H, Matthiessen LW, Wooler G, Gehl J. Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy. Acta Oncol. 2018 Mar;57(3):311-319. doi: 10.1080/0284186X.2017.1355109. Epub 2017 Aug 17.