CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Bevacizumab +2 morebiological
Likely dose
Bevacizumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01894061
NCT01894061Phase 2Completed
CompareCT.gov

A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

Case Comprehensive Cancer Center·interventional·Posted Jul 9, 2013·Updated Feb 17, 2025

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, NovoTTF-l00A, and 1 other intervention for Adult Giant Cell Glioblastoma and 3 related conditions. Completed, enrolled 25 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
CountriesUnited States
CollaboratorsNovoCure Ltd.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 9, 2013
Enrollment StartSep 18, 2013
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.0 years ago

Interventions

Bevacizumabbiological

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.

NovoTTF-l00Adevice

NovoTTF-100A will be worn continuously.

Quality of Life Assessmentother

Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire