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Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM

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ClinicalTrials.gov Identifier: NCT04492163
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : August 31, 2021
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:

This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma.

The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Device: TTFields Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental: TTFields
Patients receive continuous TTFields treatment using the Optune® System with high intensity transducer arrays.
Device: TTFields

TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.

Other Names:

• TTFields

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 18 Months ]
    PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 18 Months ]
    Survival will be measured from date of enrollment until date of death.

  2. Progression Free Survival at 6 months (PFS6) [ Time Frame: 18 Months ]
    The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RANO criteria following the time of enrollment.

  3. 1-year and 2-year survival rates [ Time Frame: 24 Months ]
    The analyses will be performed based on estimated proportions of patients who are alive at one and two years following enrollment.

  4. Overall radiological response [ Time Frame: 18 Months ]
    The percentage of patients who had either complete response or partial response per RANO criteria following enrollment

  5. Severity and frequency of adverse events [ Time Frame: 18 Months ]
    The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments

  6. Pathological changes in resected GBM tumors following study treatment [ Time Frame: 18 Months ]
    Pathological changes in the tumors of patients who consented to have pathological analysis of their tumors and also underwent another surgical resection while on the study

  7. Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed [ Time Frame: 18 months ]
  8. Dependence of Overall Survival on TTFields dose delivered to the tumor bed [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.
  2. Age ≥ 18 years
  3. Not a candidate for further radiotherapy or additional resection of residual tumor.
  4. Patients with first or second radiological disease progression per RANO criteria documented by MRI within 4 weeks prior to starting therapy with the following restriction: disease progression must be either growth of the enhancing lesion or a new lesion.
  5. Karnofsky performance status ≥ 70
  6. Life expectancy ≥ least 3 months
  7. Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
  8. All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
  9. Treatment start date at least 4 weeks out from brain surgery chemotherapy or irradiation therapy.

Exclusion Criteria:

  1. Infratentorial or leptomeningeal disease
  2. Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment.
  3. Participation in another clinical treatment study during screening and treatment phase of the study.
  4. Pregnancy or breast-feeding.
  5. Significant co-morbidities at baseline, as determined by the investigator:

    1. Thrombocytopenia (platelet count < 100 x 103/μL)
    2. Neutropenia (absolute neutrophil count < 1 x 103/μL)
    3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
    4. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
    5. Total bilirubin > 1.5 x upper limit of normal
    6. Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l)
    7. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
  6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  7. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  8. Admitted to an institution by administrative or court order.
  9. Known allergies to medical adhesives or hydrogel


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492163

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Contact: Antonia Mahnig +1 603 206 2337 clinicaltrials@novocure.com

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Nemocnice Na Homolce Recruiting
Prague, Czechia, 150 30
Contact: Josef Vymazal, Prof. MD    +420 257 272 614    Josef.Vymazal@homolka.cz   
Contact: Aaron Rulseh, PhD       aaron.rulseh@homolka.cz   
Principal Investigator: Josef Vymazal, Prof. MD         
Sponsors and Collaborators
NovoCure Ltd.
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Principal Investigator: Josef Vymazal, MD, DSc Nemocnice Na Homolce (Na Homolce Hospital

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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT04492163    
Other Study ID Numbers: EF-33
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NovoCure Ltd.:
Glioblastoma Multiforme
Recurrent Glioblastoma
Minimal Toxicity
Tumor Treating Fields
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue