GlioblastomaPhase 2NCT02283944
TMS Electrochemotherapy for Glioblastoma Multiforme
A Phase 2 study testing TMS in people with Glioblastoma, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to 31 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed and histologically confirmed glioblastoma multiform
- MGMT gene methylation
- If age < 70, eligibility to comply with the Stupp radio chemotherapy regimen
- If age > 70, eligibility for stand alone chemotherapeutic treatment
- Ability to comply with the proposed TMS treatment
- Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish Health and Medicines Authority
Who cannot join
- Pregnancy or nursing
- Other conditions that may contraindicate the use of transcranial magnetic stimulation
- Implanted pacemaker or metal contraindicating MRI-scan
About this study
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.
- Conditions
- Glioblastoma
- Being tested
- TMS
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called Transcranial Magnetic Stimulation
Pulsed non-invasive brain stimulation using electromagnets
| Study group | Role | What they receive |
|---|---|---|
| TMS electrochemotherapy | Experimental | Combined TMS (transcranial magnetic stimulation) and Temozolomide chemotherapy. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death
Time from onset primary diagnosis until death
Measured: 3 years
Secondary outcomes (2)
Time to progression
Time from diagnosis until radiological tumor progression
Measured: 3 years
Quality of Life
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completion31 May 2019
Why it stopped: Device for multi coil TMS no longer supported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders R Korshøj, MD, Principal investigator, Aarhus University Hospital, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283944
- Sponsor's protocol ID
- 15102014
- Status last verified
- Oct 2014
- First submitted
- 3 Nov 2014
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS Electrochemotherapy for Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT02283944
- Acronym / sponsor ID
- 15102014
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device for multi coil TMS no longer supported
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- 31 May 2019 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS electrochemotherapy | Experimental | Device: TMSCombined TMS (transcranial magnetic stimulation) and Temozolomide chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed and histologically confirmed glioblastoma multiform
- MGMT gene methylation
- If age < 70, eligibility to comply with the Stupp radio chemotherapy regimen
- If age > 70, eligibility for stand alone chemotherapeutic treatment
- Ability to comply with the proposed TMS treatment
Key exclusion criteria (3 listed)
- Pregnancy or nursing
- Other conditions that may contraindicate the use of transcranial magnetic stimulation
- Implanted pacemaker or metal contraindicating MRI-scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSAlso: Transcranial Magnetic StimulationPulsed non-invasive brain stimulation using electromagnets | Device | TMS electrochemotherapy |
Primary outcome
Time to death
Time frame: 3 years
Time from onset primary diagnosis until death
2 secondary outcomes
Time to progression
Time frame: 3 years
Quality of Life
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders R Korshøj, MD principal investigator
Aarhus University Hospital, Department of Neurosurgery
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMS in people with Glioblastoma, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021; AzTrials last refreshed its copy on 4 Nov 2026.