Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E in castration-resistant prostate cancer patients

Cancer Gene Therapy
K FujitaN Nonomura

Abstract

Inactivated Sendai virus particles (hemagglutinating virus of Japan envelope (HVJ-E)) have a novel antitumor effect: HVJ-E fused to prostate cancer cells via cell surface receptor causes apoptosis of prostate cancer cells in vitro and in vivo. HVJ-E also induces antitumor immunity by activating natural killer (NK) cells and cytotoxic T cells and suppressing regulatory T cells in vivo. We conducted an open-label, single-arm, phase I/II clinical trial in patients with castration-resistant prostate cancer (CRPC) to determine the safety and efficacy of intratumoral and subcutaneous injection of HVJ-E. Patients with CRPC who were docetaxel-resistant or could not receive docetaxel treatment were eligible. HVJ-E was injected directly into the prostate on day 1 and subcutaneously on days 5, 8 and 12 in two 28-day treatment cycles using a 3+3 dose-escalation design. The primary end points were to evaluate safety and tolerability of HVJ-E. The secondary end points were to analyze tumor immunity and antitumor effect. The study is registered at UMIN Clinical Trials Registry, number UMIN000006142. Seven patients were enrolled, and six patients received HVJ-E. Grade 2 or 3 adverse events (Common Terminology Criteria for Adverse Events Ver. 4...Continue Reading

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Citations

Feb 14, 2018·Informatics for Health & Social Care·Fadi Thabtah
Nov 22, 2018·Japanese Journal of Clinical Oncology·Satoru TaguchiTomoki Todo
Apr 25, 2018·Frontiers in Immunology·Sandra IuresciaMonica Rinaldi
Feb 27, 2018·Cancer Control : Journal of the Moffitt Cancer Center·Kimberly L SantucciJohn G Baust
Apr 25, 2021·Journal of Controlled Release : Official Journal of the Controlled Release Society·Dominik WitzigmannJörg Huwyler

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Methods Mentioned

BETA
xenograft
biopsy

Clinical Trials Mentioned

NCT02933255
NCT02601014
NCT02985957
NCT01832870
NCT01510288
NCT02506114

Software Mentioned

VF
ProstVac

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