Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01925573
Status:
TERMINATED
Last Update Posted:
2022-02-03
First Post:
2013-08-13
Brief Title:
OptuneNOVOTTF-100A Bevacizumab Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma GCC 1344
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Proposed Pilot Study of Combined Optune Bevacizumab and Hypofractionated Stereotactic Irradiation for Bevacizumab-Naive Recurrent Glioblastoma
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is designed to generate and provide preliminary data to determine the safety and activity of combination therapy using tumor treating fields TTFields OptuneNovoTTF-100A Novocure Haifa Israel a novel FDA-approved therapy utilizing alternating electric fields to inhibit tumor cell growth along with bevacizumab Avastin Genentech San Francisco CA a humanized monoclonal antibody that inhibits vascular endothelial growth factor VEGF and hypofractionated stereotactic radiotherapy a highly-focal abbreviated course of brain irradiation in the treatment of patients with bevacizumab-naive recurrent GBM Each of these individual therapies and also several combinations in doublets has already demonstrated safety and efficacy but prospective clinical data for the concurrent combination of all three therapies are lacking
Detailed Description:
The combination of OptuneNovoTTF with the active regimen of bevacizumab and hypofractionated stereotactic radiotherapy bases the addition of an effective new treatment in the setting of a safe regimen with favorable survival reports To date no clinical data are available on the interaction of concomitant tumor treating fields with radiation therapy either with or without bevacizumab TTF and radiation both have the potential to enhance the others therapeutic ratio though synergistic mechanisms of action The addition of bevacizumab to this regimen has both therapeutic and improved-toxicity implications A trial combining Optune with the proven regimen of HFSRT and bevacizumab for recurrent glioblastoma affords an avenue to demonstrate safety in a population who may more readily derive a benefit from novel multimodality therapy and explore the potential for synergistic effect The endpoint of efficacy would clearly need to be more definitively addressed in a future categorical trial which would be the logical positive outcome of this pilot study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None