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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492163
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : November 24, 2020
Sponsor:
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Contacts
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Contact: Antonia Mahnig +41 41 455 36 32 clinicaltrials@novocure.com

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

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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: November 24, 2020
Last Verified: November 2020

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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
GBM
Treatment
Minimal Toxicity
TTFields
Tumor Treating Fields
NovoCure
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue