Table 3.
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.