NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells.
The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.
Adult Giant Cell Glioblastoma
Recurrent Adult Brain Tumor
Other: Quality of Life Assessment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma|
- Progression Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of patients that achieve progression free survival by Kaplan Meier methodology.
- Objective response rate based on RANO Criteria [ Time Frame: 30 days after treatment completion ] [ Designated as safety issue: No ]Response will be scored based on a combination of imaging and clinical features as defined by the modified Response Assessment in Neuro-Oncology (RANO) criteria. http://www.iconplc.com/services/imaging/central-imaging-core-lab-/regulatory-expertise/IMI-RANO-Criteria-Booklet-Nov-2011.pdf
- Number of patients that experience toxicities with this combination of therapies [ Time Frame: 30 days after treatment completion ] [ Designated as safety issue: Yes ]Safety and tolerability of combination of bevacizumab and NovoTTF-l00A in this population by CTCAE version 4.0.
- Median overall survival [ Time Frame: 30 days after treatment completion ] [ Designated as safety issue: No ]
- To assess time-to-progression [ Time Frame: 30 days after treatment completion ] [ Designated as safety issue: No ]Median time to progression by Kaplan Meier methodology.
- Neurocognitive function (NCF) [ Time Frame: 30 days after treatment completion ] [ Designated as safety issue: No ]Time to reliable change (decline) in neurocognitive function by Kaplan Meier methodology. Memory, verbal fluency, visual-motor speed, executive function and motor dexterity tests will be administered.
- Quality of Life (QOL) [ Time Frame: 30 days after treatment completion ] [ Designated as safety issue: No ]Based on the Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab and NovoTTF-100A
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
Other Names:Device: NovoTTF-l00A
NovoTTF-100A will be worn continuously.
Other Name: electric field therapyOther: Quality of Life Assessment
Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
Other Name: FACT-Br questionnaire
This will be an open label Phase II trial in adults with recurrent glioblastoma (GBM). The NovoTTF-100A treatment and Bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment will be initiated in the outpatient clinic.
I. To determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive patients with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).
I. To assess safety and tolerability of the combination of bevacizumab and Novo-TTF-100A in this patient population.
II. To evaluate overall survival in this population. III. To determine objective response rate (ORR) by modified Revised Assessment in Neuro-Oncology (RANO) criteria in this population.
IV. To assess time-to-progression in this population. V. To assess neurocognitive function (NCF) and quality of life (QOL) in this population.
Patients receive bevacizumab intravenously (IV) on days 1 and 15. Patients also undergo electric field therapy with NovoTTF-100A for at least 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01894061
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Manmeet Ahluwalia, MD 216-444-6145 firstname.lastname@example.org|
|Principal Investigator: Manmeet Ahluwalia, MD|
|Study Chair:||Manmeet Ahluwalia, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|