Calcium Electroporation for Treatment of Cutaneous Metastases

Phase 2CompletedNCT01941901

Herlev Hospital7 enrolled

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.

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cutaneous Metastases

Interventions

Calcium electroporationDRUG

Intratumoral injection, once only treatment.

Electrochemotherapy with bleomycinDRUG

Intratumoral injection, once only treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Oncology, Copenhagen University Hospital, Herlev

Herlev, Denmark

Outcomes

Primary Outcomes

Tumor response

Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.

Time frame: After 6 months

Secondary Outcomes

Adverse events to calcium electroporation

Describe adverse events using Common Terminology for Adverse Events, version 4.0

Time frame: After 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.