A phase 1 clinical study of intravenous administration of PV701, an oncolytic virus, using two-step desensitization

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Scott A LaurieR M Lorence

Abstract

In a previous phase 1 study, adverse events, especially flu-like symptoms, were observed mainly following the first i.v. bolus dose of PV701, an oncolytic Newcastle disease virus. Desensitization to adverse events of subsequent doses occurred, allowing a 10-fold increase in the maximum tolerated dose for these doses. Although one-step desensitization (a single desensitizing dose with higher subsequent doses) addressed the tolerability of high repeat doses, additional testing was required to further improve tolerability of the initial dose. This study tested the hypothesis that two-step desensitization, using two dose increments before high repeat doses, would be well tolerated. Sixteen adults with incurable solid tumors were enrolled. Cycles consisted of six PV701 doses over 2 weeks followed by a 1-week rest. Doses 1 to 2 were 1 and 12 x 10(9) plaque-forming units (pfu)/m(2), respectively, whereas doses 3 to 6 were escalated by cohort from 24 to 120 x 10(9) pfu/m(2). No dose-limiting toxicities were observed, permitting dose escalation through cohort 4 (1, 12, 120, 120, 120, 120 x 10(9) pfu/m(2)). Mild flu-like symptoms were common following the first infusion, diminished with repeated dosing, and were less pronounced than thos...Continue Reading

References

Jan 1, 1995·Cancer Investigation·M L JaramilloJ C Bell
Nov 25, 2000·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·N Muñoz
Apr 28, 2001·Cytokine & Growth Factor Reviews·A E KoromilasG Matlashewski
Mar 21, 2002·Nature Reviews. Cancer·Robert W Tindle
May 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew L PecoraRobert M Lorence
Jul 12, 2002·Current Gene Therapy·J C BellD F Stojdl
Apr 17, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Oday HamidAnthony F Shields
Aug 2, 2003·Cancer Cell·John C BellDavid Stojdl
Aug 28, 2003·Drug News & Perspectives·Masahiro Toda
Apr 29, 2004·Journal of Clinical Pathology·S Syrjänen

❮ Previous
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Citations

Jun 30, 2009·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Jacqueline Nuss ParkerJames M Markert
Apr 18, 2008·Gene Therapy·T-C Liu, D Kirn
May 27, 2008·Molecular Therapy : the Journal of the American Society of Gene Therapy·Ta-Chiang LiuDavid H Kirn
Jan 30, 2007·Nature Clinical Practice. Oncology·Ta-Chiang LiuDavid Kirn
Sep 15, 2007·Journal of Virology·Scott J GoebelPaul S Masters
Jul 20, 2010·Immunotherapy·Nicolas BoisgeraultMarc Gregoire
Mar 8, 2012·Future Microbiology·Dmitriy Zamarin, Peter Palese
Jul 14, 2010·EMBO Molecular Medicine·Frederik C RoosMichael Ohh
Jun 3, 2014·Virology Journal·Suet-Lin ChiaNorazizah Shafee
Mar 9, 2012·Advances in Virology·Mark S FergusonYaohe Wang
Aug 29, 2014·Trends in Molecular Medicine·Oscar M Rollano PeñalozaMarek J Łos
Dec 26, 2015·Viruses·Diana SánchezRosa Elena Sarmiento-Silva
Nov 23, 2010·Expert Review of Vaccines·Patrycja J Lech, Stephen J Russell
Aug 13, 2008·Expert Opinion on Biological Therapy·Ta-Chiang LiuDavid H Kirn
Apr 17, 2015·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Chun-Xiao ZhangJie Yuan
May 28, 2011·Advanced Drug Delivery Reviews·Te-Lang Wu, Dongming Zhou
Jan 15, 2011·Cancer Treatment Reviews·M G BourkeG C O'Sullivan
Mar 17, 2010·Cancer Treatment Reviews·Nam P NguyenVincent Vinh-Hung
Sep 12, 2014·International Journal of Cancer. Journal International Du Cancer·Carolien A KoksStefaan W Van Gool
Nov 5, 2014·Journal of Experimental & Clinical Cancer Research : CR·Mingxu GuanEarl E Henderson
Aug 21, 2009·Veterinary and Comparative Oncology·M ArendtI M Morgan
Dec 8, 2015·Molecular Therapy Oncolytics·Olga V MatveevaPeter M Chumakov
Dec 2, 2011·Journal of Biomedicine & Biotechnology·Han Yuen LamNoorjahan Banu Alitheen
Sep 2, 2015·Nature Reviews. Drug Discovery·Howard L KaufmanAndrew Zloza
Jul 31, 2013·Oncoimmunology·Erika VacchelliLorenzo Galluzzi
Mar 23, 2017·International Journal of Urology : Official Journal of the Japanese Urological Association·Satoru TaguchiTomoki Todo
Jan 24, 2017·The Cancer Journal·Praveen K BommareddyHoward L Kaufman
Jan 1, 2013·Biology·Philippe Fournier, Volker Schirrmacher
Jul 12, 2019·Nature Reviews. Drug Discovery·Kevin HarringtonJean-Charles Soria
Apr 26, 2017·Biological Chemistry·Dörthe MasemannStephan Ludwig
May 31, 2019·Expert Opinion on Drug Delivery·Claudia Hill, Robert Carlisle
Feb 12, 2017·Medical Oncology·Yogesh R SuryawanshiKarim Essani
Jan 1, 2017·Therapeutic Innovation & Regulatory Science·Takuma MatsudaAtsushi Aruga
Oct 24, 2019·Scientific Reports·Teridah Ernala GintingGeorge Mathew

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