Electrochemotherapy as a Palliative Treatment for Brain Metastases
Electrochemotherapy is a cancer treatment modality comprising of a combination of electrical
pulses delivered by electrodes and chemotherapy supplied either intravenously or
intratumorally. It is a quick and effective treatment for cutaneous metastases < 3 cm with a
complete response rate of 73 % after once-only treatment. The available electrode devices
have so far only been applicable for cutaneous tumors. An electrode has now been developed
in collaboration with a medico-technical company. An increasing number of cancer patients
suffer from metastases to the brain due to e.g. better control of the systemic peripheral
cancer disease. The prognosis for patients with brain metastases remains poor and research
into new treatments are needed in this field.
Up to 18 patients will be treated in a dose-escalating study of electrochemotherapy for
brain metastases. Primary endpoint of the clinical trial is safety and secondary endpoint is
efficacy. One brain metastasis is treated once-only with the electrode device guided
stereotactically through a burr hole using CT monitoring. The patient will be fully
anesthetized during the treatment procedure. Patients are followed up for 6 months with
regard to neurological function, Barthel Index, steroid use and adverse effects registration
(CTCAE). Tumor response will be evaluated by Magnetic Resonance imaging (MRI).
The first 6 patients will receive an intravenous dose of bleomycin 15.000 IE/m2 before
electric pulses. The following patients will receive an additional intratumoral injection of
bleomycin of increasing concentration. The electrical pulses will consist of a series of
high voltage pulses of 0.1 millisecond duration.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of the trial treatment. This is evaluated by adverse events registrations (CTCAE).
From treatment to last follow up, planned 6 months
Julie Gehl, MD, DMSci
Department of Oncology, Herlev Hospital
Denmark: Danish Medicines Agency