Electrochemotherapy as a Palliative Treatment for Brain Metastases
Status:
Terminated
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Because electrochemotherapy is a quick and effective treatment for cutaneous metastases, a
novel electrode device has been developed for treatment in soft tissue such as the brain. Up
to 18 patients will be treated in this phase I 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).
Phase:
Phase 1
Details
Lead Sponsor:
Copenhagen University Hospital at Herlev
Collaborators:
Glostrup University Hospital, Copenhagen Rigshospitalet, Denmark