Calcium Electroporation for Treatment of Cutaneous Metastases

Cutaneous Metastases Clinical Trial

Official title:

Calcium Electroporation for Treatment of Cutaneous Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941901
• Other study ID #: AA1232
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: January 23, 2017

Study information

• Verified date: November 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 23, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Skin Neoplasms

Intervention

Drug:
• Calcium electroporation
Intratumoral injection, once only treatment.
• Electrochemotherapy with bleomycin
Intratumoral injection, once only treatment

Locations

Country	Name	City	State
Denmark	Department of Oncology, Copenhagen University Hospital, Herlev	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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):311-3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria.	It is a non-inferiority study, and we accept a difference in response on 15%.	After 6 months
Primary	Tumor response	Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.	After 6 months
Secondary	Adverse events to calcium electroporation	Describe adverse events using Common Terminology for Adverse Events, version 4.0	After 6 months