Study protocol of a Phase I/IIa clinical trial of Ad-SGE-REIC for treatment of recurrent malignant glioma.
Kazuhiko KurozumiKentaro FujiiYosuke ShimazuYusuke TomitaTatsuya SasakiTakao YasuharaTomohito HishikawaMasahiro KamedaHiromi KumonIsao DatePublished in: Future oncology (London, England) (2020)
Malignant glioma is one of the most common brain cancers in humans, which is very devastating. The expression of reduced expression in immortalized cells/Dickkopf-3 (REIC/Dkk-3) is decreased in various human cancers. Lately, we have developed a novel second-generation adenoviral vector that expresses REIC/Dkk-3 (Ad-SGE-REIC) and revealed its antiglioma efficacy. The present investigator-initiated clinical trial is a single-arm, prospective, nonrandomized, noncomparative, open-label, single-center trial performed at Okayama University Hospital, Okayama, Japan. The primary end points are dose-limiting toxicities and the incidence of adverse events. The secondary end points are the objective response rate and immunological assessment. Use of Ad-SGE-REIC will help to improve the prognosis of patients with malignant brain tumors.
Keyphrases
- clinical trial
- study protocol
- open label
- phase ii
- phase iii
- poor prognosis
- randomized controlled trial
- double blind
- induced apoptosis
- binding protein
- endothelial cells
- phase ii study
- placebo controlled
- risk factors
- endoplasmic reticulum stress
- white matter
- cell cycle arrest
- squamous cell carcinoma
- cell death
- replacement therapy
- radiation therapy
- signaling pathway
- rectal cancer
- subarachnoid hemorrhage
- locally advanced
- cell proliferation
- clinical evaluation