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

Outcome

Outcome not reported

Stopped (Enrollment): “Due to slow patient recruitment”

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