Electrochemotherapy as a Palliative Treatment for Brain Metastases
|Brain Metastases CNS Metastases||Device: The Electroporation System Drug: Bleomycin||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Electrochemotherapy as a Palliative Treatment for Brain Metastases|
- Safety of the trial treatment. This is evaluated by adverse events registrations (CTCAE). [ Time Frame: From treatment to last follow up, planned 6 months ]
- Efficacy of the trial treatment. This is evaluated by target tumor response on Magnetic resonance imaging (MRI). [ Time Frame: Patients are evaluable 50 days after treatment ]
|Study Start Date:||April 2011|
|Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Device: The Electroporation System
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322100
|Copenhagen, Denmark, 2100|
|Herlev, Denmark, 2730|
|Principal Investigator:||Julie Gehl, MD, DMSci||Department of Oncology, Herlev Hospital|