scholarly journals Response Assessment in Pediatric Neuro-Oncology: Implementation and Expansion of the RANO Criteria in a Randomized Phase II Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas

2016 ◽  
Vol 37 (9) ◽  
pp. 1581-1587 ◽  
Author(s):  
T. Jaspan ◽  
P.S. Morgan ◽  
M. Warmuth-Metz ◽  
E. Sanchez Aliaga ◽  
D. Warren ◽  
...  
Keyword(s):  
Phase Ii ◽  
Pediatric Patients ◽  
Phase Ii Trial ◽  
Response Assessment ◽  
High Grade ◽  
Newly Diagnosed ◽  
Rano Criteria ◽  
Randomized Phase Ii ◽  
High Grade Gliomas

scholarly journals Phase II Trial of Erlotinib during and after Radiotherapy in Children with Newly Diagnosed High-Grade Gliomas

2014 ◽  
Vol 4 ◽  
Author(s):  
Ibrahim Qaddoumi ◽  
Mehmet Kocak ◽  
Atmaram S. Pai Panandiker ◽  
Gregory T. Armstrong ◽  
Cynthia Wetmore ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
Newly Diagnosed ◽  
High Grade Gliomas

scholarly journals RADI-05. EVALUATION OF THE IMPLEMENTATION OF THE RANO CRITERIA IN THE HERBY TRIAL OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED HIGH-GRADE GLIOMAS

2018 ◽  
Vol 20 (suppl_2) ◽  
pp. i170-i170
Author(s):  
Daniel Rodriguez ◽  
Paul Morgan ◽  
Daniel Warren ◽  
Monika Warmuth-Metz ◽  
Esther Aliaga-Sanchez ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
High Grade ◽  
Newly Diagnosed ◽  
Rano Criteria ◽  
High Grade Gliomas

scholarly journals Hydroxychloroquine and short-course radiotherapy in elderly patients with newly diagnosed high-grade glioma: a randomized phase II trial

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Lucy Brazil ◽  
Angela L Swampillai ◽  
Ka Man Mak ◽  
Darren Edwards ◽  
Pavlina Mesiri ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade Glioma ◽  
High Grade ◽  
Newly Diagnosed ◽  
Randomized Phase Ii ◽  
Short Course ◽  
Radiotherapy Alone ◽  
Short Course Radiotherapy

Abstract Background Effective treatment for patients at least 70 years with newly diagnosed glioblastoma remains challenging and alternatives to conventional cytotoxics are appealing. Autophagy inhibition has shown promising efficacy and safety in small studies of glioblastoma and other cancers. Methods We conducted a randomized phase II trial to compare radiotherapy with or without hydroxychloroquine (2:1 allocation). Patients aged at least 70 years with newly diagnosed high-grade glioma deemed suitable for short-course radiotherapy with an ECOG performance status of 0–1 were included. Radiotherapy treatment consisted of 30 Gy, delivered as 6 fractions given over 2 weeks (5 Gy per fraction). Hydroxychloroquine was given as 200 mg orally b.d. from 7 days prior to radiotherapy until disease progression. The primary endpoint was 1-year overall survival (OS). Secondary endpoints included progression-free survival (PFS), quality of life, and toxicity. Results Fifty-four patients with a median age of 75 were randomized between May 2013 and October 2016. The trial was stopped early in 2016. One-year OS was 20.3% (95% confidence interval [CI] 8.2–36.0) hydroxychloroquine group, and 41.2% (95% CI 18.6–62.6) radiotherapy alone, with a median survival of 7.9 and 11.5 months, respectively. The corresponding 6-month PFS was 35.3% (95% CI 19.3–51.7) and 29.4% (95% CI 10.7–51.1). The outcome in the control arm was better than expected and the excess of deaths in the hydroxychloroquine group appeared unrelated to cancer. There were more grade 3–5 events in the hydroxychloroquine group (60.0%) versus radiotherapy alone (38.9%) without any clear common causation. Conclusions Hydroxychloroquine with short-course radiotherapy did not improve survival compared to radiotherapy alone in elderly patients with glioblastoma.

Phase II trial of topotecan (T) as a continuous intravenous infusion in patients (PTS) with high grade gliomas

1997 ◽  
Vol 33 ◽  
pp. S203
Author(s):  
A. Kyritsis ◽  
E.S. Newlands ◽  
C.S. Brock ◽  
K. Jaeckle ◽  
V. Levin ◽  
...  
Keyword(s):  
Phase Ii ◽  
Intravenous Infusion ◽  
Phase Ii Trial ◽  
High Grade ◽  
Continuous Intravenous Infusion ◽  
High Grade Gliomas

Results of a phase II trial of h-R3 monoclonal antibody (nimotuzumab) in the treatment of resistant or relapsed high-grade gliomas in children and adolescents

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1522-1522 ◽  
Author(s):  
U. Bode ◽  
S. Buchen ◽  
G. Janssen ◽  
T. Reinhard ◽  
M. Warmuth-Metz ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Phase Ii ◽  
Induction Therapy ◽  
Phase Ii Trial ◽  
Phase Iii ◽  
High Grade ◽  
Consolidation Therapy ◽  
Pontine Glioma ◽  
Multicentre Phase ◽  
High Grade Gliomas

1522 Background: Children and adolescents suffering from high grade gliomas (HGG) have a poor prognosis when they relapse during or after primary treatment. Thus novel therapeutic approaches as the inhibition of growth-signalling pathways are needed. This multicentre phase II trial was designed to explore the feasibility and efficacy of the h-R3 monoclonal anti-EGFR antibody (Nimotuzumab) in the treatment of these patients. Methods: Pediatric patients with glioblastoma multiforme, anaplastic astrocytoma or intrinsic pontine glioma (PG) with radiologically proven progressive disease following primary or relapse treatment were eligible to the study. The treatment consisted of an induction therapy including a weekly short infusion of 150 mg/m2 Nimotuzumab for six weeks, and in case of non-PD a subsequent consolidation therapy of four infusions in a three week interval. The response was documented by MRI in week 8 and 21. Results: Between June 2004 and August 2005 34 patients aged 5.0 to 17.4 years (median 10.9 years) were enrolled in this study. According to RECIST 12 out of 34 patients showed response (PR n=1, SD n=11) in the MRI of week 8 after the induction therapy with a median change in the largest diameter of the index lesion of −5% (−39 to +16%) accompanied by clinical deterioration in four and markedly clinical improvement in two patients. Surprisingly, 9 PR/SD were seen in the 14 patients with PG. Eight patients continued with the consolidation therapy. So far 5 out of 8 Patients are evaluable for response after consolidation therapy and showed three PR, one SD and one PD in week 21. Eight patients with consolidation therapy are free of progression for a median of 7.5 months (1.2–13.2 months). No severe side effects related to the study medication were observed. Conclusions: These data suggest that the repeated application of Nimotuzumab is well tolerated and safe. It has cytotoxic efficacy in heavily pre-treated relapsed HGG, especially in intrinsic pontine glioma. A phase III study for patients with newly diagnosed PG is warranted. [Table: see text]

Prospective phase II trial for recurrent high-grade gliomas with capacitive coupled low radiofrequency (LRF) hyperthermia

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 2047-2047 ◽  
Author(s):  
E. D. Hager ◽  
H. Sahinbas ◽  
D. H. Groenemeyer ◽  
F. Migeod
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
Prospective Phase ◽  
High Grade Gliomas
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