Study protocol of a Phase I/IIa clinical trial of Ad-SGE-REIC for treatment of recurrent malignant glioma

Kazuhiko Kurozumi, Kentaro Fujii, Yosuke Shimazu, Yusuke Tomita, Tatsuya Sasaki, Takao Yasuhara, Tomohito Hishikawa, Masahiro Kameda, Hiromi Kumon, Isao Date

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)151-159
Number of pages9
JournalFuture Oncology
Volume16
Issue number6
DOIs
Publication statusPublished - Jan 1 2020

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Keywords

  • DKK3
  • gene therapy
  • malignant glioma
  • prognosis
  • safety

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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