Phase I study of chlorogenic acid injection for recurrent high-grade glioma with long-term follow-up.

ABSTRACT:

Objective

This study was aimed at analyzing the efficacy and safety of an injectable form of chlorogenic acid (CGA) in patients with recurrent high-grade glioma after standard of care treatments, through a first-in-human, open-label, dose-escalation phase I trial.

Methods

A total of 26 eligible patients were enrolled, received intramuscular CGA injections at 5 dose levels, and were followed up for 5 years. CGA was well tolerated, and the maximum tolerated dose was 5.5 mg/kg.

Results

The most common treatment-related adverse events occurred at the sites of injection. No grade 3 or 4 adverse events (e.g., drug allergy) were reported for these patients except for induration at the injection sites. A clinical pharmacokinetic study showed that CGA was rapidly eliminated fr

SUBMITTER: Kang Z 

PROVIDER: S-EPMC10291982 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature