Brief Summary

The proposed project aims to develop novel electrochemotherapeutic treatment of glioblastoma multiforme (GBM). Standard treatment has limited effect on survival and quality of life. Electrochemotherapy is a novel and promising treatment, which has demonstrated convincing results in the treatment of various types of carcinoma. The treatment is based on a combination of electrical current stimulation of tumor cells and simultaneous administration of chemotherapeutic drugs. Electrochemotherapy works by inducing an electrical current between implanted electrodes in the tumor tissue, causing electroporation of the cancer cell membranes, and thereby increasing the cellular permeability and drug uptake. Electrochemotherapy has proven to be an efficient way of considerably increasing the potency of the chemotherapeutic drug bleomycin in malignant cells in skin tumors and carcinoma metastases, and thereby increasing cytotoxicity of the drug locally in the tumor tissue. This allows for treatment with lower doses of chemotherapeutic drugs and more defined, local area of effect, thus decreasing systemic effects. The investigators propose to use a novel non-invasive and safe technique called focused transcranial magnetic stimulation (focused TMS) to induce electrical current in the tumor tissue. TMS is a safe and widely implemented technology used to treat multiple neurological diseases such as pain, depression and stroke. Studies have shown that effective electroporation of cell membranes can be obtained using induction of electromagnetic fields in a cell suspension, and new focused TMS further enables focused treatment of selected brain regions without surgical intervention and, thereby focusing chemotherapeutic treatment to pathological tissue and avoiding surgery related brain tissue damage. Additionally, TMS transiently increases blood-brain barrier permeability, theoretically allowing increased uptake of chemotherapeutic drugs in the target area. This addresses a significant challenge in the treatment of brain cancer, as most cytotoxic drugs have fairly limited ability to pass the blood brain barrier. The intention of this research project is to investigate the therapeutic potential of focused TMS as an alternative non-invasive source of current induction and thereby means to treat several types of brain cancer with electrochemotherapy.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Jan 2015

Typical duration for phase_2

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

November 3, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed

Last Updated

September 20, 2021

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

November 3, 2014

Last Update Submit

September 13, 2021

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

Time to death
Time from onset primary diagnosis until death
3 years

Secondary Outcomes (2)

Time to progression
3 years
Quality of Life
3 years

Study Arms (1)