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

August 13, 2024 updated by: NovoCure GmbH

EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.

TTFields intensity has been shown to be positively correlated with patient outcome. The new transducer array design is expected to reduce skin heating and thus enable delivery of higher TTFields intensities while keeping the safety profile of the treatment unchanged.

The purpose of the study is to test if delivering TTFields using high intensity transducer arrays for recurrent GBM significantly improves the clinical outcome of patients, compared to using the standard transducer arrays.

The study will enroll 25 patients.

All patients included in this clinical investigation are patients with histologically confirmed diagnosis of GBM with first or second radiological disease progression per RANO criteria.

In addition, all patients must meet all eligibility criteria.

Baseline assessments will be performed to confirm patient eligibility in the study.

Enrolled patients will be treated continuously with the device until disease progression per RANO criteria or 18 months (the earlier of the two) unless any of the treatment discontinuation conditions described under criteria for patient withdrawal or termination are met.

Concurrent brain directed antitumor therapy or procedures beyond TTFields is prohibited.

TTFields treatment will start within 28 days following signing the informed consent.

After the initial visit, subjects will continue treatment at home, while pursuing normal daily routines. Subjects are required to use the device for at least 18 hours a day. Short breaks in treatment for personal hygiene and other personal needs is allowed. Total usage time will be recorded and provided to the sponsor.

Subjects will be required to return to the clinic every 4 weeks and every 8 weeks after first 12 visits, until disease progression. At each study visit an examination by a physician and a routine laboratory examination will be performed.

A contrast enhanced MRI of the head will be performed at baseline and every 4 weeks for the first 24 weeks and then at least every 12 weeks, until disease progression.

A post-treatment termination visit will be performed approximately 30 days after discontinuation of TTfields treatment or disease progression (the latter of the two).

Following disease progression, subjects will be contacted once per month by telephone to answer basic questions about their health status.

Pathological analysis of GBM tumor samples, which may be obtained prior and during the study period, will be performed based on subjects' consent to have an experimental pathological examination of their tumors.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 150 30
        • Nemocnice Na Homolce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 18 Months
Survival will be measured from date of enrollment until date of death.
18 Months
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.
18 Months
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.
24 Months
Overall radiological response
Time Frame: 18 Months
The percentage of patients who had either complete response or partial response per RANO criteria following enrollment
18 Months
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
18 Months
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
18 Months
Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed
Time Frame: 18 months
18 months
Dependence of Overall Survival on TTFields dose delivered to the tumor bed
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovoCure GmbH

Investigators

  • Principal Investigator: Josef Vymazal, MD, DSc, Nemocnice Na Homolce (Na Homolce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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