scholarly journals Phase II Trial of Lower Dose Bevacizumab and Irinotecan in Relapsed High Grade Gliomas

2015 ◽  
Vol 1 (2) ◽  
Author(s):  
Kairouz VF ◽  
Kamar FG ◽  
Dimassi H ◽  
Comair YG
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
High Grade Gliomas

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

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

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

Phase II trial of ritonavir/lopinavir in patients with progressive or recurrent high-grade gliomas

2010 ◽  
Vol 102 (2) ◽  
pp. 317-321 ◽  
Author(s):  
Manmeet S. Ahluwalia ◽  
Carol Patton ◽  
Glen Stevens ◽  
Tanya Tekautz ◽  
Lilyana Angelov ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
High Grade Gliomas

Phase II Trial with BCNU plus α-Interferon in Patients with Recurrent High-Grade Gliomas

1997 ◽  
Vol 20 (4) ◽  
pp. 364-367 ◽  
Author(s):  
Alba Ariela Brandes ◽  
Elvira Scelzi ◽  
Paolo Zampieri ◽  
Alberto Rigon ◽  
Antonino Rotilio ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
High Grade Gliomas

A phase II trial of LY317615 in patients with recurrent high grade gliomas

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 1511-1511 ◽  
Author(s):  
H. A. Fine ◽  
L. Kim ◽  
C. Royce ◽  
S. Mitchell ◽  
J. P. Duic ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
High Grade Gliomas

Results from phase II trial of enzastaurin (LY317615) in patients with recurrent high grade gliomas

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 1504-1504 ◽  
Author(s):  
H. A. Fine ◽  
L. Kim ◽  
C. Royce ◽  
D. Draper ◽  
I. Haggarty ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
High Grade ◽  
High Grade Gliomas

Final report of a phase II trial of nimotuzumab in the treatment of refractory and relapsed high-grade gliomas in children and adolescents

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2006-2006 ◽  
Author(s):  
U. Bode ◽  
S. Buchen ◽  
M. Warmuth-Metz ◽  
T. Pietsch ◽  
F. Bach ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Primary Treatment ◽  
Phase Iii ◽  
Final Report ◽  
High Grade ◽  
Consolidation Therapy ◽  
Multicentre Phase ◽  
Best Response ◽  
High Grade Gliomas

2006 Background: Despite multimodal therapy most children with high grade gliomas (HGG), including glioblastoma multiforme (GM), anaplastic astrocytoma (AA) and intrinsic pontine glioma (PG) have an infaust prognosis if they relapse or are refractory to the primary treatment. Recently novel therapeutic approaches are investigated in order to improve the survival of these patients while preserving a good quality of life. 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. Patients and Methods: Pediatric patients with GM, AA or PG with radiologically proven progressive disease following primary or relapse treatment and a life expectancy of less than 4 weeks 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 consolidation therapy of 4 infusions in a 3 week interval. The response was documented by MRI in week 8 and 21 and only clinically in rapidly progresssive disease. Results: Between June 2004 and April 2006 47 patients aged 4 to 17 years (median 11 years) were enrolled in this study. 46 patients were evaluable for response. According to RECIST 14 out of 46 patients showed objective responses (PR n=4, SD n=10) in the MRI as the best response with a median change in the largest diameter of the index lesion of -11% (-50% to +16%). The PR/SD were seen in 2/13 patients with GM, 2/11 with AA and 10/22 with PG. Thirteen patients continued with the consolidation therapy and showed 4 PR, 3 SD and 6 PD in week 21. The median overall survival was 4.4 months (0.3–25.4 months) and was significantly better for repsonders (median 10 months) than for nonresponders (median 4.0 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. Nimotuzumab has cytotoxic efficacy in heavily pre- treated relapsed HGG. Based on this data a phase III trial with nimotuzumab in newly diagnosed diffuse intrinsic pontine gliomas concomittent with radiotherapy was introduced in first quarter 2006. No significant financial relationships to disclose.

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