NovoTTF Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
|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: NCT01954576|
Recruitment Status : Recruiting
First Posted : October 7, 2013
Last Update Posted : March 21, 2019
|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.
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.
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): 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|