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

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.

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Priming immunotherapy with radiotherapy (RT) in advanced non-small cell lung cancer (NSCLC) and head and neck squamous cell cancer (HNSCC): Interim analysis of phase II clinical trial.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.2628 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 2628-2628

Author(s):

Aasems Jacob ◽

Alexander Kreimer ◽

Jing Wei ◽

Jianrong Wu ◽

Lauren Corum ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Phase Ii ◽

Interim Analysis ◽

Cell Cancer ◽

Phase Ii Clinical Trial ◽

Cell Phenotype ◽

Second Line ◽

Combination Methods ◽

Grade 3

2628 Background: Preclinical models demonstrate that combined RT with immune checkpoint inhibitor (ICI) results in specific CD8+ T-cell phenotype associated with a tumor-reactive population resulting in significant tumor response. Sequential treatment could allow radiation to release tumor antigens from immune inaccessible areas and provide robust anti-tumor immune response with ICI. We report an interim analysis of the phase II clinical trial evaluating the efficacy and safety of the combination. Methods: Advanced NSCLC and HNSCC patients who had initiated on FDA approved single-agent ICI were eligible. Patients were given SBRT (BED>100Gy) or 30 Gy fractionated RT delivered as a 3-dimensional dose to a single metastatic site within 14 days of the first ICI dose. Primary objective was 6-month PFS and secondary objectives were safety and tolerability, 1Y PFS and OS. This interim analysis was done after enrollment of 43 patients. Results: Between 10/2017 to 1/2021, 43 patients were enrolled, and 38 included in this analysis. Median age was 62 years; 26 patients were male. 9 patients received ICI for NSCLC as first-line, 7 for NSCLC second-line and 22 for HNSCC second-line. 24 patients received pembrolizumab and 14 nivolumab; 21 had SBRT and 17 fractionated RT. Median follow up duration was 11.8m (range: 2.7 - 31.4m) for patients without progressive disease (PD). 10 patients were off-study, 7 continuing treatment. 15 died and 26 had PD. 14 patients died of malignancy and cause of death for one patient was unknown. 6-month PFS was 49.19% with median PFS of 5.5 months. (table) Fifty-two grade-3-5 adverse events (AEs) were reported among 21 subjects. Most common were transaminitis (n=15), lymphopenia (n=8), and GI side effects (n=4). Treatment related AEs included 19 grade-3 events, and none were grade 4/5. Two grade-5 AEs were from PD (oral bleeding and unspecified). There were 20 grade-1/2 and 3 grade-3 immune related adverse events (IRAEs). No grade-4/5 IRAEs were reported. Two patients discontinued treatment due to grade 3 transaminitis. Conclusions: Interim analysis shows that 6m PFS was acceptable with majority of patients being second-line metastatic HNSCC who historically had mPFS of 2.1-2.3 months and mOS 7.7-8.4 months in Checkmate-141/KEYNOTE-040 trials. Hence, the combination is of further interest and accrual will continue to reach the goal. The combination therapy was tolerable without unexpected AEs. Majority of deaths were from disease progression. No treatment related grade 4/5 adverse events were reported. Two patients discontinued treatment due to grade-3 IRAE. Clinical trial information: NCT03313804. [Table: see text]

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Interim Analysis of a Phase II Clinical Trial of Induction Gemcitabine/Capecitabine followed by SABR in Borderline/Locally Advanced Pancreatic Adenocarcinoma

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2014.05.178 ◽

2014 ◽

Vol 90 (1) ◽

pp. S48-S49

Author(s):

K. Quan ◽

M.S. Rajagopalan ◽

D.A. Clump ◽

R.E. Wegner ◽

S. Burton ◽

...

Keyword(s):

Clinical Trial ◽

Pancreatic Adenocarcinoma ◽

Phase Ii ◽

Interim Analysis ◽

Locally Advanced ◽

Phase Ii Clinical Trial ◽

Locally Advanced Pancreatic Adenocarcinoma ◽

Advanced Pancreatic Adenocarcinoma

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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

Archivio Italiano di Urologia e Andrologia ◽

10.4081/aiua.2017.3.197 ◽

2017 ◽

Vol 89 (3) ◽

pp. 197 ◽

Cited By ~ 6

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.

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