Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04492163
Status:
COMPLETED
Last Update Posted:
2021-08-31
First Post:
2020-07-27
Brief Title:
Open-Label Pilot Study of OPTUNE With High Density Transducer Arrays for the Treatment of Recurrent GBM
Sponsor:
NovoCure Ltd
Organization:
NovoCure Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None