Electrochemotherapy as a Palliative Treatment for Brain Metastases
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).
Timeline
- Start
- 2011-04
- Primary completion
- 2013-07
- Completion
- 2013-07
Publications
- Background Linnert M, Gehl J. Bleomycin treatment of brain tumors: an evaluation. Anticancer Drugs. 2009 Mar;20(3):157-64. doi: 10.1097/CAD.0b013e328325465e.
- Background Gothelf A, Mir LM, Gehl J. Electrochemotherapy: results of cancer treatment using enhanced delivery of bleomycin by electroporation. Cancer Treat Rev. 2003 Oct;29(5):371-87. doi: 10.1016/s0305-7372(03)00073-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 2000 iu | Intravenous |
| Subject | Bleomycin | Unknown | 4000 iu | Intravenous |
| Subject | Bleomycin | Unknown | 6000 iu | Intravenous |
| Subject | Bleomycin | Unknown | 15000 unknown | Intravenous |