Poor Accrual
A Phase II, Multi-institutional Trial of NOVO-TTF-100A, BCNU and Bevacizumab for GBM in First Relapse
Sponsor study identifier
Secondary identifiers
OTHER · UC Davis
OTHER · University of California Davis Comprehensive Cancer Center
NIH
REGISTRY · CTRP (Clinical Trial Reporting Program)
interventional
0
1 country
2
Study Start
January 2016
Actual (reported)Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and carmustine and to see how well they work in treating patients with glioblastoma multiforme that has returned for the first time. NovoTTF-100A, a type of electric field therapy, delivers low intensity, alternating "wave-like" electric fields that may interfere with multiplication of the glioblastoma multiforme cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NovoTTF-100A together with bevacizumab and carmustine may be an effective treatment for glioblastoma multiforme.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2015
Actual (reported)January 28, 2015
Actual (reported)January 2016
Actual (reported)January 2017
Actual (reported)January 2017
Actual (reported)Incidence of adverse events, assessed by National Cancer Institute-Common Terminology Criteria 4.0 toxicity criteria
Toxicity summaries will be provided for all subjects who have received any part of the study treatment. Statistical analysis will include estimates of proportions with each class of toxicity with a 95% confidence interval.
Up to 12 months
Progression Free Survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 6 months
Overall Survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time from first day of treatment to time of death due to any cause, assessed up to 6 months
Quality of life as measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN-20 brain cancer module
Up to 6 months
Change in tumor volume using magnetic resonance imaging (MRI)
Mean change in linear dimension will be evaluated for shrinkage using a paired t-test. If the assumption of normality is violated, a signed rank test will be used. The Response Assessment in Neuro-oncology (RANO) criteria will be part of the MRI evaluation.
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks beginning on day -7 for up to 13 doses and carmustine IV over 4 hours every 8 weeks beginning on day 1 for up to 3 doses. Patients also undergo NovoTTF-100A according to standard procedures starting one week before the first dose of carmustine.
Undergo NovoTTF-100A
Given IV
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Robert O'Donnell
University of California, Davis
0 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2015
First Posted
January 28, 2015
Study Start
January 2016
Actual (reported)Primary Completion
Baseline to day 168
Change in linear dimension using MRI
Mean change in linear dimension will be evaluated for shrinkage using a paired t-test. If the assumption of normality is violated, a signed rank test will be used. The RANO criteria will be part of the MRI evaluation.
Baseline to day 168
Given IV
Ancillary studies
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
January 9, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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