Study design and participants
death, toxicity, SD, high-grade glioma, glioma
DISEASE, SECONDARY, GLIOMA
This was an open-label, dose-escalation, phase I study. The primary objectives were to assess the safety and tolerability of CGA injection in patients with recurrent high-grade glioma. The secondary objectives were to characterize the pharmacokinetic profile and evaluate the antitumor activity of CGA injection. The primary endpoints were the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary endpoints were quality of life; the disease control rate, defined as the percentage of assessable patients with complete response, partial response, or stable disease (SD); and the OS, defined as the time from treatment allocation to death due to any cause. Changes in immune and cytokine markers were also assessed as exploratory endpoints. The study is registered in China (Patients aged 18 years or older with histologically diagnosed advanced and recurrent glioma, including grade 3 and 4 glioma, for whom standard chemotherapy or radiotherapy failed, were eligible for this study. Eligible patients had a life expectancy longer than 3 months and a KPS score above 40. Additional eligibility criteria included white blood cell count ≥ 3.0 × 10The use of specimens and patient information was approved by the Ethics Committees of the Beijing Tiantan Hospital of Capital Medical University (Approval No. 2016004). All patients provided written consent for the use of their specimens and disease information for the study, in accordance with the Ethics Committee approval and the Declaration of Helsinki.