Calcium Electroporation for Treatment of Cutaneous Metastases

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

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%.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Calcium electroporation
    • The metastases will be treated with intratumoral injection of calcium chlorid followed by electrotransfer. It is a once-only treatment. Calcium chlorid concentration: 9mg/ml. Total dose: 0,5ml/cm3 tumor volume.
  • Active Comparator: Electrochemotherapy with bleomycin
    • The metastases will be treated with intratumoral injection of bleomycin followed by electrotransfer. It is a once only treatment. bleomycin concentration: 1000 IU/ml. Total dose: o,5 ml/cm3 tumor volume.

Clinical Trial Outcome Measures

Primary Measures

  • Tumor response
    • Time Frame: After 6 months
    • Response evaluated by “Response Evaluation Criteria in Solid Tumors” (RECIST) guidelines version 1.1.

Secondary Measures

  • Adverse events to calcium electroporation
    • Time Frame: After 6 months
    • Describe adverse events using Common Terminology for Adverse Events, version 4.0

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Herlev Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie Gehl, Medical Doctor – Herlev Hospital
  • Overall Official(s)
    • Julie Gehl, Principal Investigator, Department of Oncology, Copenhagen University hospital, Herlev

References

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.

Citations Reporting on Results

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.

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