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

Published on Jan 24, 2020in Future Oncology2.66
· DOI :10.2217/FON-2019-0743
Kazuhiko Kurozumi23
Estimated H-index: 23
(Okayama University),
Kentaro Fujii8
Estimated H-index: 8
(Okayama University)
+ 7 AuthorsIsao Date58
Estimated H-index: 58
(Okayama University)
Sources
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.
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