drugset / Trial / NCT01322100

Electrochemotherapy as a Palliative Treatment for Brain Metastases

NCT01322100

Non-randomizedSingle-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown 2000 iu Intravenous
Subject Bleomycin Unknown 4000 iu Intravenous
Subject Bleomycin Unknown 6000 iu Intravenous
Subject Bleomycin Unknown 15000 unknown Intravenous