TMS electrochemotherapy - a new treatment for glioblastoma brain cancer

Phase 1

• Conditions: Glioblastoma Multiforme (WHO grade IV brain tumor); MedDRA version: 17.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000608-24-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-25
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Age 18 years or older
2.Newly diagnosed and histologically confirmed GBM
3.MGMT gene methylation
4.If age < 70 years: Eligability for and ability to comply with the Stupp [4] chemo-radiotherapy regimen.
5.If age > 70: Eligibility for stand alone chemotherapeutic treatment (without radiotherapy).
6.Ability to comply with the proposed TMS treatment.
7.Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish Health and Medicines Authority.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1.Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
2.Conditions that may contraindicate the use of transcranial magnetic stimulation (see Safety Summary for Cervel Neurotech Clinical rTMS Devices, and Cervel Neurotech rTMS System User Manual). Specifically this will include the represent of magnetic implants in the brain, uncontrollable symptomatic epilepsy refractory to standard medication, lack of ability to comply with TMS treatment.
3. Implanted pacemaker or metal contraindicating the use of MRI-scan.
4. Participation in clinical trials, which may by the investigators’ opinion interfere with or compromise treatment efficacy or safety or the interpretation and reliability of results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to examine the use of non-invasive focused magnetic brain stimulation (focused TMS) as a method to potentiate the effect of chemotherapeutic treatment of GBM (TMS electrochemotherapy). Patients with debut of GBM will receive TMS as supplementary treatment to standard post-operative chemotherapy and concomitant radiotherapy.;Secondary Objective: N/A;Primary end point(s): Primary endpoints:<br>1. Time to recurrence/progression<br>2. Mortality rate;Timepoint(s) of evaluation of this end point: 9 months interim<br>2 years final

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints:<br>1. Changes in tumor volume<br>2. Toxicity and safety (CTCAE version4.0)<br> 3. QoL;Timepoint(s) of evaluation of this end point: 9 months interim<br>2 years final