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. 2020 Feb 6;2(1):vdaa013. doi: 10.1093/noajnl/vdaa013

Table 3.

Clinical Trials Involving SGT for HGG Treatment

Trial No. Start– Completiona Phase Patients Vector Used Suicide Gene/ Prodrug Combination Result Citation
NCT00751270 2005–2011 Ib Newly diagnosed HGG AdV HSV1-TK/ valACV RT+TMZb Safety assessed 20
NCT00589875 2007–2015 Iia Newly diagnosed HGG AdV HSV1-TK/ valACV RT+TMZb Safety assessed 45
NCT00870181 2008–2012 II Recurrent HGG AdV HSV1-TK/ GCV N/A Improved survival 42
NCT01172964 2010–2015 I Recurrent HGG NSC(HB1. F3.CD) bCD/5FC Safety assessed 46
NCT00634231 2010–2015 I Newly diagnosed HGG (pediatric) AdV HSV1-TK/ valACV RT+TMZb Safety assessed/ ongoing 47
NCT01156584 2010–2016 I Recurrent HGG RRV yCD/5FC N/A
NCT01470794 2012–2016 I Recurrent HGG (undergoing surgery) RRV yCD/5FC N/A Safety + encouraging efficacy 48,49
NCT01985256 2014–2016 I Recurrent HGG (undergoing surgery) RRVc yCD/5FC N/A
NCT02015819 2014–2019 I Recurrent HGG NSC(HB1. F3.CD) bCD/5FC+ Leucovorin N/A Ongoing
NCT01811992 2014–2020 I Newly diagnosed HGG AdV HSV1-TK/ valACV AdV-Flt3L Ongoing
NCT02414165 2015–2019 II-III Recurrent HGG RRV yCD/5FC 50
NCT02192359 2016–2020 I Recurrent HGG HB1. F3.CD21. hCE1m6 hCE1m6/ irinotecan Ongoing
NCT03596086 2017–2023 I-II Recurrent HGG AdV HSV1-TK/ valACV RT+TMZ Ongoing
NCT03603405 2018–2023 I-II Newly diagnosed HGG AdV HSV1-TK/ valACV RT+TMZ Ongoing
NCT03576612 2018–2021 PI Newly diagnosed HGG AdV HSV1-TK/ valACV RT+ Nivolumab+TMZb Ongoing
NCT02598011 2016–2022 I Newly diagnosed HGG RRV yCD/5FC RT+TMZ Planned

Only the trials carried on/undertaken/planned since 2010 are mentioned here. See review from Kaufmann et al.36 where some of the trials before 2010 are discussed.

aPrimary completion.

bTMZ allowed after prodrug administration.

cIntravenous administration.