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Electrochemotherapy as a Palliative Treatment for Brain Metastases

NCT01322100 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-07-31

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

The Electroporation System

The Electroporation System comprises of 3 parts: 1.Switch Box, 2. Driver, 3. Brain Probe

DRUG

Bleomycin

Bleomycin dosage for i.v. use is 15.000 IU/m2, and is administered 10-30 minutes before the electric pulses. Bleomycin dosage for intratumoral use is either 2.000 IU, 4.000 IU, or 6.000 IU per 3 ml, and 20 % of the calculated tumor volume is injected.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Glostrup University Hospital, Copenhagen

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Julie Gehl, MD, DMSci · Department of Oncology, Herlev Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322100 on ClinicalTrials.gov