Confirmatory Trial in the Evaluation of Ca Electroporation for the Treatment of Cutaneous Metastases

NACompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

September 20, 2016

Primary Completion Date

June 4, 2019

Study Completion Date

June 4, 2019

Conditions
Cutaneous Melanoma
Interventions
PROCEDURE

Calcium Electroporation

"If the patient agrees biopsies will be performed from the tumor area before and after electroporation during local anaesthesia. Maximum of 8 biopsies will be done, depending on the patient's number of metastases.~All patient's regardless of the number of metastases will have one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code is revealed at day 180.~Patients with more than 6 metastases: One to two biopsies before treatment, one to two biopsies one week after treatment from metastases treated with calcium and bleomycin respectively.~All biopsies will be handled according to current guidelines and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."

PROCEDURE

Bleomycin based electrochemotherapy

"If the patient agrees biopsies will be performed from the tumor area before and after electroporation during local anaesthesia. Maximum of 8 biopsies will be done, depending on the patient's number of metastases.~All patient's regardless of the number of metastases will have one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code is revealed at day 180.~Patients with more than 6 metastases: One to two biopsies before treatment, one to two biopsies one week after treatment from metastases treated with calcium and bleomycin respectively.~All biopsies will be handled according to current guidelines and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."

All Listed Sponsors
lead

Szeged University

OTHER

NCT03628417 - Confirmatory Trial in the Evaluation of Ca Electroporation for the Treatment of Cutaneous Metastases | Biotech Hunter | Biotech Hunter