NovoTTF Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT01954576|
Recruitment Status : Recruiting
First Posted : October 7, 2013
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Brain Neoplasms||Device: NovoTTF-100A Procedure: Quality-of-life assessment Genetic: Laboratory biomarker analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Optune System, Enhanced by Genomic Analysis to Identify the Genetic Signature of Response in the Treatment of Recurrent Glioblastoma Multiforme|
|Actual Study Start Date :||October 10, 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2021|
Experimental: NovoTTF therapy
Patients undergo NovoTFF therapy at least 18 hours daily for 6 months (bevacizumab-naive) or 4 months (bevacizumab-refractory). Treatment may continue for up to 2 years in patients experiencing CR, PR, or SD.
|Device: NovoTTF-100A Procedure: Quality-of-life assessment Genetic: Laboratory biomarker analysis|
- ORR (CR + PR + SD) (bevacizumab-naive) [ Time Frame: 6 months ]Assessed using Response Assessment in Neuro-Oncology (RANO). A Fisher's exact test with two-sided 0.05 and 80% power will be used.
- ORR (CR + PR + SD) (bevacizumab-refractory) [ Time Frame: 4 months ]Assessed using RANO. A Fisher's exact test with two-sided 0.05 and 80% power will be used.
- Genetic signature of response (CR + PR + SD) [ Time Frame: up to 6 months ]
- Genetic signature of response (CR + PR) and SD [ Time Frame: Up to 6 months ]
- Progression-free survival in bevacizumab-naïve and bevacizumab-refractory glioblastoma patients [ Time Frame: Assessed up to 2 years ]Defined as start of treatment to time of progression or death, whichever occurs first. Will be estimated by Kaplan-Meier curves.
- Quality of Life [ Time Frame: Up to 30 days post-treatment ]Assessed using the Karnofsky performance status and the mini-mental state examination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954576
|Contact: Sonisha Warrenfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: David D Tran, M.D., Ph.D. 352-273-9000 email@example.com|
|Sub-Investigator: Ashley Ghiaseddin, M.D.|
|Principal Investigator: David D Tran, M.D., Ph.D.|
|Sub-Investigator: William Friedman, M.D.|
|Sub-Investigator: Anthony Yachnis, M.D.|
|Sub-Investigator: Gregory Murad, M.D.|
|Sub-Investigator: Steven Roper, M.D.|
|United States, Missouri|
|Washington University School of Medicine||Terminated|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||David Tran, M.D., Ph.D.||University of Florida|