SU-E-T-183: Feasibility of Extreme Dose Escalation for Glioblastoma Multiforme Using 4π Radiotherapy

2014 ◽  
Vol 41 (6Part14) ◽  
pp. 264-265
Author(s):  
D Nguyen ◽  
J Rwigema ◽  
V Yu ◽  
T Kaprealian ◽  
P Kupelian ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Dose Escalation ◽  
4Π Radiotherapy

scholarly journals Feasibility of extreme dose escalation for glioblastoma multiforme using 4π radiotherapy

2014 ◽  
Vol 9 (1) ◽  
Author(s):  
Dan Nguyen ◽  
Jean-Claude M Rwigema ◽  
Victoria Y Yu ◽  
Tania Kaprealian ◽  
Patrick Kupelian ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Dose Escalation ◽  
4Π Radiotherapy

scholarly journals INTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study

BMC Cancer ◽  
2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Frank A Giordano ◽  
Stefanie Brehmer ◽  
Yasser Abo-Madyan ◽  
Grit Welzel ◽  
Elena Sperk ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Phase I ◽  
Dose Escalation ◽  
Intraoperative Radiotherapy ◽  
Dose Escalation Study

Boron Neutron Capture Therapy for Glioblastoma Multiforme: Interim Results from the Phase I/II Dose-Escalation Studies

Neurosurgery ◽  
1999 ◽  
Vol 44 (6) ◽  
pp. 1182-1193 ◽  
Author(s):  
Arjun D. Chanana ◽  
Jacek Capala, ◽  
Manjeet Chadha ◽  
Jeffrey A. Coderre ◽  
Aidnag Z. Diaz ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Phase I ◽  
Dose Escalation ◽  
Boron Neutron Capture Therapy ◽  
Neutron Capture ◽  
Neutron Capture Therapy ◽  
Boron Neutron Capture

Phase I/II dose-escalation study of VB-111, an antiangiogenic gene therapy, in patients with recurrent glioblastoma multiforme.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS2102-TPS2102 ◽  
Author(s):  
Andrew Jacob Brenner ◽  
Yael Cohen ◽  
James J Vredenburgh ◽  
Katherine B. Peters ◽  
Eyal Breitbart ◽  
...  
Keyword(s):  
Overall Survival ◽  
Glioblastoma Multiforme ◽  
Phase I ◽  
Dose Escalation ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
High Dose ◽  
Recurrent Glioblastoma Multiforme ◽  
Dose Escalation Study ◽  
Recurrent Gbm

TPS2102 Background: VB-111 is an anti-angiogenic agent consisting of a non-replicating adenovirus vector (Ad-5) with a modified murine pre-proendothelin promoter leading to apoptosis of tumor vasculature by expressing a fas-chimera transgene in angiogenic endothelial cells. In a phase I/II dose-escalation study, safety and efficacy of VB-111 in patients with recurrent Glioblastoma Multiforme (GBM) were evaluated. Methods: VB-111 was administered as a single intravenous infusion at escalating doses from 1x1012 to 3x1012 viral particles (VPs), followed by repeat doses of 3x1012 or 1x1013every 2 months. Assessments included safety, pharmacokinetics, tumor response (RANO criteria) and overall survival (OS). Results: Twenty eight patients aged 26 – 74 years at 3 medical centers in the US received up to 8 repeat doses of VB-111. The median OS was 360 [range: 70-574] and 266 days [range: 28-664] for patients receiving at least one dose of 1x1013VPs (high dose) vs. subjects who received lower doses, respectively (p NS). Progression free survival was 87 vs 55 days for patients who received high dose and for lower doses, respectively (p = 0.01). Median follow-up was 232 days. Three patients had a partial response (PR) at 82, 86 and 408 days post initial VB-111 dosing. Twenty one of the patients who progressed on VB-111 treatment received bevacizumab off study; 7 of the 15 evaluable patients (47%) had a PR compared to 30% expected according to literature. VB-111 was safe and well tolerated, 53 adverse events were reported, 14 were classified as possibly related to VB-111. All events were of CTCAE grade 1-2 except one grade 3 pulmonary embolism. There were no study related deaths. One patient developed peri-tumoral edema, which resolved with corticosteroid therapy. Events occurring in > 10% of the patients included headache and fatigue. Conclusions: VB-111 was safe and well tolerated in patients with recurrent GBM with repeat doses of up to 1x1013 VPs. Tumor responses were seen. Overall survival was about 3 months longer than historical data in recurrent GBM, including standard of care anti-angiogenic agents. Data suggests that VB-111 potentiates the response to bevacizumab given at further progression. Clinical trial information: NCT01260506.

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