RTID-07. AN INVESTIGATOR-LEAD PHASE II CLINICAL TRIAL OF ACCELERATOR-BASED BNCT FOR REFRACTORY AND RECURRENT HIGH-GRADE MENINGIOMA

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi194-vi194
Author(s):  
Shin-Ichi Miyatake ◽  
Shinji Kawabata ◽  
Satoshi Takai ◽  
Masahiko Wanibuchi
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Supportive Care ◽  
Phase Ii ◽  
Best Supportive Care ◽  
Phase Ii Clinical Trial ◽  
Care Group ◽  
High Grade ◽  
Neutron Sources ◽  
Control Subjects

Abstract BACKGROUD Boron neutron capture therapy (BNCT) is tumor-selective particle radiation. We applied this unique technique and achieved excellent clinical results for recurrent and refractory high-grade meningiomas (HGM) using reactor neutron sources (Neuro-Oncology, in press, doi:10.1093/neuonc/noab108). Recently accelerator-based neutron sources (ABNS) was approved for medical device in Japan for refractory H&N cancers. PURPOSES Based on these situations, we proposed “A phase II clinical trial using accelerator-based BNCT system for refractory recurrent HGM” for AMED in Japan which is similar to NIH in USA. This proposal was successfully accepted. DESIGN We prepared 2 study groups, BNCT test treatment group and control best supportive care group, for RCT. PFS and OS were set-up as primary and secondary endpoints, respectively. Rescue BNCT is allowed for control group patients, if they showed PD during observation. The trial started in August 2019. METHODS Twelve BNCT and 6 control subjects will be included. Patients’ eligibility criteria is recurrent HGM after some radiotherapy. Cyclotron-based ABNS system is used for neutron source. Neutron-irradiation time is determined not to exceed to 7.5 Gy-Eq for scalp dose which was referencing preceding phase I trial for malignant gliomas. PROGRESS As of March 2021, 13 subjects were included, 9 for BNCT treatment group, 4 for control best supportive care group. All 4 control subjects showed PD during 2 months while 8 out of 9 subjects showed SD or PR during observation period and there is a statistical significance in both groups, by Log-rank and Wilcoxon analyses with p=0.0012 and 0.0020, respectively. CONCLUSION We started this RCT and will introduce the interim report of this clinical trial in the meeting. At the SNO meeting we will present further detail of this trial.

scholarly journals CTNI-56. A PHASE II CLINICAL TRIAL USING ACCELERATOR-BASED BNCT SYSTEM FOR REFRACTORY RECURRENT HIGH-GRADE MENINGIOMA

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii55-ii55
Author(s):  
Shin-Ichi Miyatake ◽  
Masahiko Wanibuchi ◽  
Shinji Kawabata ◽  
Naonori Ko ◽  
Koji Ono
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Supportive Care ◽  
Phase Ii ◽  
Malignant Gliomas ◽  
Best Supportive Care ◽  
Care Group ◽  
Control Group ◽  
High Grade ◽  
And Control

Abstract BACKGROUND Boron neutron capture therapy (BNCT) is tumor-selective particle radiation. Recently accelerator-based neutron sources (ABNS) have been developed for clinical trials to obtain on-label use, i.e. new drug approval for malignant gliomas. Recently Japanese regulatory authority has just given this permission for H&N cancers. Recurrent high-grade meningiomas (HGM) are difficult to control. We have applied reactor-based BNCT for 46 cases of refractory HGM. All cases showed good tumor shrinkage with good local control. PURPOSES Based on these situations, we proposed “A phase II clinical trial using accelerator-based BNCT system for refractory recurrent HGM” for AMED in Japan which is similar to NIH in USA. This proposal was successfully accepted. DESIGN We prepared 2 study groups, BNCT test treatment group and control best supportive care group, for RCT. PFS and OS were set-up as primary and secondary endpoints, respectively. Rescue BNCT is allowed for control group patients, if they showed PD during observation. Modified Macdonald criteria is adopted for assessment. Hypothesized PFS of treatment group and control group was 5 months and 24 months, respectively. The trial started in August 2019. METHODS Twelve BNCT and 6 control subjects will be included. Patients’ eligibility criteria is recurrent HGM after some radiotherapy. Cyclotron-based ABNS system is used for neutron source. Neutron-irradiation time is determined not to exceed to 7.5 Gy-Eq for scalp dose which was referencing preceding phase I trial for malignant gliomas. PROGRESS As of April 2020, 4 subjects were included, 3 for BNCT treatment group, 1 for control best supportive care group. The control subject showed PD during one month observation and rescue treatment showed PR. Treatment group 3 cases showed more than SD. CONCLUSION We started this RCT and will introduce the interim report of this clinical trial in the meeting.

scholarly journals AT-46 * VORINOSTAT AND BEVACIZUMAB FOR RECURRENT HIGH-GRADE GLIOMA: INTERIM ANALYSIS OF A PHASE II CLINICAL TRIAL

2014 ◽  
Vol 16 (suppl 5) ◽  
pp. v18-v18
Author(s):  
K. Peters ◽  
D. Reardon ◽  
D. Randazzo ◽  
S. Dutton ◽  
A. Edwards ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Interim Analysis ◽  
High Grade Glioma ◽  
Phase Ii Clinical Trial ◽  
High Grade

Alpha-type-1 Polarized Dendritic Cell-based Vaccination in Newly Diagnosed High-grade Glioma: A Phase II Clinical Trial

2020 ◽  
Vol 40 (11) ◽  
pp. 6473-6484
Author(s):  
KOICHI MITSUYA ◽  
YASUTO AKIYAMA ◽  
AKIRA IIZUKA ◽  
HARUO MIYATA ◽  
SHOICHI DEGUCHI ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dendritic Cell ◽  
Phase Ii ◽  
High Grade Glioma ◽  
Phase Ii Clinical Trial ◽  
High Grade ◽  
Newly Diagnosed ◽  
Alpha Type

scholarly journals Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

2017 ◽  
Vol 89 (3) ◽  
pp. 197 ◽  
Author(s):  
Salvatore Micali ◽  
Angelo Territo ◽  
Giacomo Maria Pirola ◽  
Nancy Ferrari ◽  
Maria Chiara Sighinolfi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Green Tea ◽  
Phase Ii ◽  
Intraepithelial Neoplasia ◽  
Phase Ii Clinical Trial ◽  
High Grade ◽  
Double Blind ◽  
Tea Catechins ◽  
Study Objective ◽  
Green Tea Catechins

Background and study objective: Several studies suggest a protective role of green tea catechins against prostate cancer (PCa). In order to evaluate the efficacy of green tea catechins for chemoprevention of PCa in patients with high-grade prostate intraepithelial neoplasia (HG-PIN) we performed a phase II clinical trial. Methods: Sixty volunteers with HG-PIN were enrolled to carry out a double-blind randomized placebo-controlled phase II clinical trial. Treated group took daily 600 mg of green tea catechins (Categ Plus®) for 1 year. Patients were screened at 6 and 12 months through prostatic biopsy and measurements of prostate-specific antigen (PSA). Results: Despite the statistically significant reduction of PSA observed in subjects who received green tea catechins for 6 and 12 months, we did not find any statistical difference in PCa incidence between the experimental groups neither after 6 nor after 12 months. However, throughout the one-year follow- up we observed very limited adverse effects induced by green tea catechins and a not significant improvement in lower urinary tract symptoms and quality of life. Conclusions: Although the small number of patients enrolled in our study and the relatively short duration of intervention, our findings seems to deny the efficacy of green tea catechins. However, results of our clinical study, mainly for its low statistical strength, suggest that the effectiveness of green tea catechins should be evaluated in both a larger cohort of men and longer trial.

scholarly journals A prospective Phase II clinical trial of 5-aminolevulinic acid to assess the correlation of intraoperative fluorescence intensity and degree of histologic cellularity during resection of high-grade gliomas

2016 ◽  
Vol 124 (5) ◽  
pp. 1300-1309 ◽  
Author(s):  
Darryl Lau ◽  
Shawn L. Hervey-Jumper ◽  
Susan Chang ◽  
Annette M. Molinaro ◽  
Michael W. McDermott ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Fluorescence Intensity ◽  
Aminolevulinic Acid ◽  
Correlation Coefficients ◽  
Phase Ii Clinical Trial ◽  
High Grade ◽  
Predictive Values ◽  
High Grade Gliomas ◽  
Grade 3

OBJECT There is evidence that 5-aminolevulinic acid (ALA) facilitates greater extent of resection and improves 6-month progression-free survival in patients with high-grade gliomas. But there remains a paucity of studies that have examined whether the intensity of ALA fluorescence correlates with tumor cellularity. Therefore, a Phase II clinical trial was undertaken to examine the correlation of intensity of ALA fluorescence with the degree of tumor cellularity. METHODS A single-center, prospective, single-arm, open-label Phase II clinical trial of ALA fluorescence-guided resection of high-grade gliomas (Grade III and IV) was held over a 43-month period (August 2010 to February 2014). ALA was administered at a dose of 20 mg/kg body weight. Intraoperative biopsies from resection cavities were collected. The biopsies were graded on a 4-point scale (0 to 3) based on ALA fluorescence intensity by the surgeon and independently based on tumor cellularity by a neuropathologist. The primary outcome of interest was the correlation of ALA fluorescence intensity to tumor cellularity. The secondary outcome of interest was ALA adverse events. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs), and Spearman correlation coefficients were calculated. RESULTS A total of 211 biopsies from 59 patients were included. Mean age was 53.3 years and 59.5% were male. The majority of biopsies were glioblastoma (GBM) (79.7%). Slightly more than half (52.5%) of all tumors were recurrent. ALA intensity of 3 correlated with presence of tumor 97.4% (PPV) of the time. However, absence of ALA fluorescence (intensity 0) correlated with the absence of tumor only 37.7% (NPV) of the time. For all tumor types, GBM, Grade III gliomas, and recurrent tumors, ALA intensity 3 correlated strongly with cellularity Grade 3; Spearman correlation coefficients (r) were 0.65, 0.66, 0.65, and 0.62, respectively. The specificity and PPV of ALA intensity 3 correlating with cellularity Grade 3 ranged from 95% to 100% and 86% to 100%, respectively. In biopsies without tumor (cellularity Grade 0), 35.4% still demonstrated ALA fluorescence. Of those biopsies, 90.9% contained abnormal brain tissue, characterized by reactive astrocytes, scattered atypical cells, or inflammation, and 8.1% had normal brain. In nonfluorescent (ALA intensity 0) biopsies, 62.3% had tumor cells present. The ALA-associated complication rate among the study cohort was 3.4%. CONCLUSIONS The PPV of utilizing the most robust ALA fluorescence intensity (lava-like orange) as a predictor of tumor presence is high. However, the NPV of utilizing the absence of fluorescence as an indicator of no tumor is poor. ALA intensity is a strong predictor for degree of tumor cellularity for the most fluorescent areas but less so for lower ALA intensities. Even in the absence of tumor cells, reactive changes may lead to ALA fluorescence.

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