Phase I/IIa trial of autologous formalin-fixed tumor vaccine concomitant with fractionated radiotherapy for newly diagnosed glioblastoma

2011 ◽  
Vol 115 (2) ◽  
pp. 248-255 ◽  
Author(s):  
Yoshihiro Muragaki ◽  
Takashi Maruyama ◽  
Hiroshi Iseki ◽  
Masahiko Tanaka ◽  
Chie Shinohara ◽  
...  
Keyword(s):  
Overall Survival ◽  
Tumor Vaccine ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Fractionated Radiotherapy ◽  
Newly Diagnosed Glioblastoma ◽  
Analysis Of Results ◽  
Formalin Fixed ◽  
Fixed Tumor

Object The objective of the present study was analysis of results of the prospective clinical trial directed toward the evaluation of therapeutic efficacy of the administration of autologous formalin-fixed tumor vaccine (AFTV) concomitant with fractionated radiotherapy in cases of newly diagnosed glioblastoma multiforme. Methods Twenty-four patients were enrolled into the clinical trial, while 2 cases were excluded from the final analysis of results. The treatment protocol included aggressive tumor resection, fractionated radiotherapy up to a total dose of 60 Gy, and 3 concomitant courses of AFTV administered with an interval of one week at the late stage of irradiation. Two delayed-type hypersensitivity (DTH) tests were done—one 48 hours before the initial course of vaccination (DTH-1) and one 2 weeks after the third (DTH-2). All but one of the patients received salvage therapy at the time of tumor progression. The defined primary end point was overall survival; secondary end points were progression-free survival and safety of concomitant treatment. Results The median duration of overall survival was 19.8 months (95% CI 13.8–31.3 months). The actuarial 2-year survival rate was 40%. The median duration of progression-free survival was 7.6 months (95% CI 4.3–13.6 months). Overall survival showed a statistically significant association with recursive partitioning analysis class (p < 0.05); progression-free survival showed a statistically significant association with p53 staining index (p < 0.05) and size of DTH-2 response (p < 0.001). AFTV injection concomitant with fractionated radiotherapy was well tolerated by all patients and in no case did treatment-related adverse effects exceed Grade 1 toxicity; adverse effects were limited to local erythema, induration, and swelling at the site of injection. Conclusions The results of this study demonstrate that AFTV treatment concomitant with fractionated radiotherapy may be effective in patients with newly diagnosed glioblastoma. Further clinical testing is warranted.

Final results of a single-arm phase II study of bevacizumab and temozolomide following radiochemotherapy in newly dignosed adult glioblastoma patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 2076-2076 ◽  
Author(s):  
Martin Kelly Nicholas ◽  
Rimas Vincas Lukas ◽  
Christine Amidei ◽  
Nicholas Vick ◽  
Nina Paleologos ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Treatment ◽  
Treatment Phase ◽  
Progression Free Survival ◽  
Concomitant Administration ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Intention To Treat ◽  
Newly Diagnosed Glioblastoma ◽  
Post Radiation

2076 Background: This study evaluated efficacy and safety of bevacizumab (BEV) added to the post-radiation treatment phase for patients with newly diagnosed glioblastoma (GBM). Methods: Sixty-two participants with newly diagnosed GBM were enrolled between May 2007 and June 2010. Participants received standard radiation therapy (RT) within 6 weeks of surgery, and concomitant administration of temozolomide (TMZ). Four weeks after radiation, treatment with TMZ (Days 1-5 of a 28 day cycle) with BEV, (days 1 and 15 of a 28 day cycle) was started, and continued until disease progressed or adverse effects indicated need to stop treatment. Analyses were completed for all participants by intention to treat (ITT), with progression-free survival (PFS) and overall survival (OS) serving as primary and secondary endpoints respectively. Results: Subbjects completed a mean of 7.7 (range 0-29) cycles of post-RT with BEV and TMZ. Twenty participants (32%) were unable to proceed to the post-RT phase. The forty-two participants who did proceed to the post-RT phase completed a mean of 11.5 cycles of treatment. Thirty-eight participants (61%) stopped the study due to disease progression; 6 participants (14%) voluntarily discontinued treatment after 24 cycles with at least stable disease. At a median follow-up time of 24 months, median progression-free survival (PFS) for all participants was 8.8 months while median overall survival (OS) was 16.5 months for all participants. Ly with These results also compare favorably with recently reported results from the AVAglio study (PFS = 10.6 mo.). The toxicity profile was consistent with that reported in similar studies. MGMT promoter methtion.ylation status is under investiga Conclusions: Participants in this study demonstrated a median 1.9 month PFS benefit as compared to the 6.9 median OS reported by Stupp, et al. (2005) and a median 1.9 month OS benefit as compared to the 14.6 month median OS reported by Stupp, et al. (2005). Results suggest that the addition of bevacizumab to the post-RT phase of treatment improves both PFS and OS for persons with GBM despite the high percentage of participants being unable to progress to post-radiation treatment. Clinical trial information: NCT005906.

Phase I/IIa trial of autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 2069-2069
Author(s):  
Y. Muragaki ◽  
T. Maruyama ◽  
H. Iseki ◽  
K. Tsuboi ◽  
A. Matsumura ◽  
...  
Keyword(s):  
Phase I ◽  
Tumor Vaccine ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma ◽  
Formalin Fixed ◽  
Fixed Tumor

scholarly journals OS09.8 Randomized placebo-controlled trial of autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma

2017 ◽  
Vol 19 (suppl_3) ◽  
pp. iii20-iii20 ◽  
Author(s):  
Y. Muragaki ◽  
T. Maruyama ◽  
E. Ishikawa ◽  
M. Nitta ◽  
S. Ikuta ◽  
...  
Keyword(s):  
Tumor Vaccine ◽  
Controlled Trial ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma ◽  
Formalin Fixed ◽  
Fixed Tumor

scholarly journals Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial

Cancers ◽  
2018 ◽  
Vol 10 (10) ◽  
pp. 372 ◽  
Author(s):  
Johanna Buchroithner ◽  
Friedrich Erhart ◽  
Josef Pichler ◽  
Georg Widhalm ◽  
Matthias Preusser ◽  
...  
Keyword(s):  
Overall Survival ◽  
Dendritic Cells ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Severe Toxicity ◽  
Newly Diagnosed ◽  
Skin Reactions ◽  
Local Skin ◽  
Free Survival ◽  
Newly Diagnosed Glioblastoma

Dendritic cells (DCs) are antigen-presenting cells that are capable of priming anti-tumor immune responses, thus serving as attractive tools to generate tumor vaccines. In this multicentric randomized open-label phase II study, we investigated the efficacy of vaccination with tumor lysate-charged autologous DCs (Audencel) in newly diagnosed glioblastoma multiforme (GBM). Patients aged 18 to 70 years with histologically proven primary GBM and resection of at least 70% were randomized 1:1 to standard of care (SOC) or SOC plus vaccination (weekly intranodal application in weeks seven to 10, followed by monthly intervals). The primary endpoint was progression-free survival at 12 months. Secondary endpoints were overall survival, safety, and toxicity. Seventy-six adult patients were analyzed in this study. Vaccinations were given for seven (3–20) months on average. No severe toxicity was attributable to vaccination. Seven patients showed flu-like symptoms, and six patients developed local skin reactions. Progression-free survival at 12 months did not differ significantly between the control and vaccine groups (28.4% versus 24.5%, p = 0.9975). Median overall survival was similar with 18.3 months (vaccine: 564 days, 95% CI: 436–671 versus control: 568 days, 95% CI: 349–680; p = 0.89, harzard ratio (HR) 0.99). Hence, in this trial, the clinical outcomes of patients with primary GBM could not be improved by the addition of Audencel to SOC.

scholarly journals Guideline conformity to the Stupp regimen in patients with newly diagnosed glioblastoma multiforme in China

2021 ◽  
Author(s):  
Yu Wang ◽  
Jianmin Zhang ◽  
Wenbin Li ◽  
Taipeng Jiang ◽  
Songtao Qi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Glioblastoma Multiforme ◽  
Median Overall Survival ◽  
Maintenance Phase ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Newly Diagnosed Glioblastoma

Aims: To determine how consistently Chinese glioblastoma multiforme (GBM) patients were treated according to the Stupp regimen. Patients and methods: The proportion of treatments conforming to the Stupp regimen and reasons for nonconformity were evaluated in 202 newly diagnosed GBM patients. Results: Only 15.8% of GBM patients received treatments compliant with the Stupp regimen. The main deviations were temozolomide dosages >75 mg/m2 (58/120; 48.3%) and treatment durations <42 days (84/120; 70.0%) in the concomitant phase and temozolomide dosages <150 mg/m2 (89/101; 88.1%) in the maintenance phase. Median overall survival (27.09 vs 18.21 months) and progression-free survival (14.27 vs 12.10 months) were longer in patients who received Stupp regimen-compliant treatments. Conclusion: Increased conformity to the Stupp regimen is needed for GBM patients in China.

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