The EF-33 trial is a prospective, pilot (analogous to a drug Phase II), single arm, historical control study designed to test effectiveness and safety of Tumor Treating Fields (TTFields) delivered through High Intensity Arrays in recurrent GBM. During the study, TTFields at 200 kHz are generated by a medical device, Optune® with High Intensity Transducer Arrays [About TTFields], which is used by the patient at home. The trial is expected to enroll a total of 25 patients.
The trial is now enrolling patients in Czech Republic. This is a monocentric trial, meaning that only one site is involved in the trial [EF-33 Center].
The EF-33 Trial Design
Patients who were recently diagnosed with recurrent GBM (first or second recurrence) are candidates for this trial. Final eligibility in the trial can only be determined by the clinical trial doctor at the clinical trial center.
The patient will receive continuous TTFields (200 kHz) treatment using Optune® with High Intensity Transducer Arrays. In order to apply the device, the patient needs to wear four arrays on their scalp, which deliver the fields non-invasively to the brain.
Transducer Array placement requires shaving of the scalp before starting to use the device. New sets of arrays will need to be applied on a regular basis for as long as the device is used.
The use of the device will start in an outpatient setting and will include training on the operation of the equipment by a qualified Novocure Device Support Specialist (DSS). Patients will continue to use the device at home [Living with TTFields]. Patients using Optune® with High Intensity Transducer Arrays can maintain the use of the device alone (with the help of a family member or a care giver if needed) or may receive support from their DSS.
The device is designed to be user-friendly and all technical aspects related to using it are maintained by the DSS. The DSS can also help patients in finding technical solutions, to allow each individual to receive TTFields while maintaining his/her normal daily routines.
For the complete list of eligibility criteria please go to clinicaltrials.gov or consult with the EF-33 clinical study doctor.
Inclusion Criteria (summary, not complete list):
- Diagnosis of GBM, with first or second radiological progression
- At least 18 years of age
- Agreement to participate in the clinical trial (“informed consent”)
Exclusion Criteria (summary, not complete list):
- Infratentorial or leptomeningeal disease
- Other serious medical conditions, which will not allow the participation in the study
- Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment
- Implanted pacemaker, defibrillator and implanted electronic devices in the brain
Expected total enrollment is 25 patients. The trial is now enrolling patients in Czech Republic. This is a monocentric trial, meaning that only one site is involved in the trial.
Please contact the center as soon as possible if you would like to participate in the EF-33 trial [EF-33 Center].
The trial sponsor (Novocure) will pay for reasonable technical treatment-related supplies, including Optune® with High Intensity Transducer Arrays and accessories. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care. The trial sponsor will also reimburse patients for some travel costs related to the trial’s procedures. Such reimbursement can be done only according to the policy and approval of the trial center at which the patient is being treated. Please consult with the clinical trial team at the center prior to enrolling in the trial about the local reimbursement policy and your rights.
If you are unable to reach the study center and receive complete information about the study, please email patient info with any questions and mention “EF-33” in the subject line.
|Nemocnice Na Homolce|
|Prague, Czechia, 150 30|
|Principal Investigator: Josef Vymazal, Prof. MD, DSc
Contact: Josef Vymazal, Prof. MD, DSc
+420 257 272 614 Josef.Vymazal@homolka.cz
|Contact: Aaron Rulseh, PhD Aaron.Rulseh@homolka.cz|