Table 1.
Comprehensive overview of clinical trials for viral vector-based therapies in brain malignancies (1992–2023)
| ClinicalTrials.Gov identifier | Clinical phase | Viral vector | Interventions | Administration scheme | Participants | Trial status | Age | Pathology |
|---|---|---|---|---|---|---|---|---|
| NCT00634231 | 1 | adenovirus | AdV-TK + valacyclovir | injections into the tumor bed during surgical procedure | 8 | completed (2010–2021) | child, adult | malignant glioma, recurrent ependymoma |
| NCT01811992 | 1 | adenovirus | Ad-hCMV-TK + Ad-hCMV-Flt3L + valacyclovir | injections into the tumor cavity during surgical procedure | 19 | completed (2014–2021) | adult | malignant glioma, glioblastoma multiforme |
| NCT02026271 | 1 | adenovirus | Ad-RTS-hIL-12 + veledimex | injection into the wall of resection cavity | 40 | completed (2014–2021) | adult | glioblastoma multiforme, anaplastic oligoastrocytoma |
| NCT03679754 | 1 | adenovirus | Ad-RTS-hIL-12 + veledimex | veledimex prior to resection and Ad injection during surgery | 36 | completed (2018–2021) | adult | recurrent glioblastoma |
| NCT03636477 | 1 | adenovirus | Ad-RTS-hIL-12 + veledimex + nivolumab | administered nivolumab 1 week preoperatively, followed by veledimex prior to resection, and Ad injection during surgery | 21 | completed (2018–2021) | adult | glioblastoma |
| NCT03576612 | 1 | adenovirus | AdV-TK + valacyclovir + nivolumab | AdV injections into the wall of the resection cavity, followed by valacyclovir 1–3 days post-surgery, and nivolumab injections 2 weeks post-surgery | 36 | active, not recruiting (2018–) | adult | malignant glioma |
| NCT05139056 | 1 | adenovirus | neural stem cells expressing CRAd-S-pk7 | NSC carrier into the tumor cavity | 36 | recruiting (2021–) | adult | recurrent high-grade glioma, astrocytoma, oligodendroglioma |
| NCT03330197 | 1 and 2 | adenovirus | Ad-RTS-hIL-12 + veledimex | veledimex prior to resection and Ad injection during surgery | 6 | completed (2017–2021) | child, adult | pediatric brain tumor, DIPG |
| NCT03596086 | 1 and 2 | adenovirus | AdV-(HSV-TK) + valacyclovir | injections into the tumor cavity during surgical procedure | 62 | recruiting (2018–) | adult | glioblastoma, astrocytoma grade III |
| NCT03603405 | 1 and 2 | adenovirus | AdV-(HSV-TK) + valacyclovir | Injections into the tumor cavity during surgical procedure | 62 | recruiting (2018–) | adult | glioblastoma, anaplastic astrocytoma |
| NCT04006119 | 2 | adenovirus | Ad-RTS-hIL-12 + veledimex + cemiplimab-Rwlc | administered cemiplimab-rwlc 1 week preoperatively, followed by veledimix prior to resection, and Ad injection during surgery | 40 | completed (2019–2023) | adult | glioblastoma |
| NCT00870181 | 2 | adenovirus | ADV-TK | intrarterial cerebral infusion | 47 | completed (2009–2013) | adult | malignant glioma, glioblastoma multiforme |
| NCT00589875 | 2 | adenovirus | AdV-TK + valacyclovir | AdV injections into the tumor bed post-surgical resection | 52 | completed (2007-2017) | adult | malignant glioma, glioblastoma multiforme, anaplastic astrocytoma |
| NCT00805376 | 1 | oncolytic adenovirus | DNX-2401 (Delta-24-RGD-4C) | intratumoral injection | 37 | completed (2009–2015) | adult | brain tumor, CNS diseases |
| NCT02197169 | 1 | oncolytic adenovirus | DNX-2401 + IFN-γ | OV injection into the tumor followed by IFN-γ | 37 | completed (2014–2018) | adult | glioblastoma, gliosarcoma |
| NCT03178032 | 1 | oncolytic adenovirus | DNX-2401 | virus infusion through the cerebellar peduncle | 12 | active, not recruiting (2017–) | child | brainstem glioma, DIPG |
| NCT03714334 | 1 | oncolytic adenovirus | DNX-2440 | administered virus during surgical procedures using a cannula | 24 | recruiting (2018–) | adult | glioblastoma |
| NCT03896568 | 1 | oncolytic adenovirus | Ad5-DNX-2401 | mesenchymal stem cells loaded with a tumor-selective OV, DNX-2401, administered via intra-arterial injection | 36 | recruiting (2019–) | adult | IDH1 WT allele, recurrent glioblastoma, recurrent anaplastic astrocytoma |
| NCT01956734 | 1 | oncolytic adenovirus | DNX-2401 + temozolomide | intratumoral OV injection into the tumor cavity followed by temozolomide | 31 | completed (2013–2017) | adult | glioblastoma, recurrent glioblastoma |
| NCT01582516 | 1 and 2 | oncolytic adenovirus | Delta-24-RGD | virus administered intratumorally using four catheters | 20 | completed (2010–2014) | adult | recurrent glioblastoma |
| NCT04758533 | 1 and 2 | oncolytic adenovirus | AloCELYVIR (mesenchymal allogenic cells + ICOVIR-5) | weekly intravenous infusion of AloCELYVIR for 8 weeks | 12 | recruiting (2021–) | child, adult | DIPG, medulloblastoma, glioma |
| NCT02798406 | 2 | oncolytic adenovirus | DNX-2401 + pembrolizumab | intratumoral OV injection into the tumor cavity followed by intravenous pembrolizumab | 49 | completed (2016–2021) | adult | glioblastoma, gliosarcoma, malignant glioma |
| NCT00157703 | 1 | oncolytic HSV-1 | G207 | intratumoral injection into the tumor cavity | 9 | completed (2005–2008) | adult | malignant glioma |
| NCT02457845 | 1 | oncolytic HSV-1 | G207 | a single dose of G207 infused through catheters into the tumor | 13 | active, not recruiting (2016–) | child, adult | progressive or recurrent supratentorial neoplasms |
| NCT03911388 | 1 | oncolytic HSV-1 | G207 | a single dose of G207 infused through catheters into the tumor | 15 | recruiting (2019–) | child | recurrent or refractory cerebellar brain tumors |
| NCT02062827 | 1 | oncolytic HSV-1 | M032 (NSC 733972) | a single dose of M032 infused through catheters into the tumor | 24 | active, not recruiting (2013–) | adult | recurrent glioblastoma, progressive glioblastoma, anaplastic astrocytoma |
| NCT03152318 | 1 | oncolytic HSV-1 | rQNestin34.5v.2 + cyclophosphamide | cyclophosphamide was administered intravenously two days pre-operatively followed by OV Injections into the tumor cavity during a surgical procedure | 62 | recruiting (2017–) | adult | recurrent malignant glioma, astrocytoma, oligodendroglioma |
| NCT05084430 | 1 and 2 | oncolytic HSV-1 | M032 (NSC 733972) + pembrolizumab | oncolytic HSV that expresses IL12 administered into the tumor bed followed by pembrolizumab intravenous injection of a total of three combined doses | 28 | recruiting (2021–) | adult | glioblastoma, gliosarcoma, anaplastic astrocytoma |
| NCT00028158 | 1 and 2 | oncolytic HSV-1 | G207 | administered virus during surgical resection into the tumor | 65 | completed (2001–2003) | adult | glioma, astrocytoma, glioblastoma |
| NCT04482933 | 2 | oncolytic HSV-1 | G207 | intratumoral infusion through four silastic catheters | 40 | not yet recruiting (2023–) | child, adult | recurrent pediatric high-grade glioma |
| NCT03043391 | 1 | oncolytic poliovirus | polio/rhinovirus recombinant (PVSRIPO) | administered intratumorally via convection-enhanced delivery using an intracerebral catheter | 12 | active, not recruiting (2017–) | child, adult | recurrent malignant glioma, astrocytoma, ATRT, oligodendroglioma |
| NCT00390299 | 1 | oncolytic MV | MV-CEA (carcinoembryonic antigen expressing) | injection into the tumor cavity | 23 | completed (2006–2019) | adult | anaplastic astrocytoma, oligodendroglioma |
| NCT02962167 | 1 | oncolytic MV | MV-NIS | injections into the tumor bed post-surgical resection | 46 | recruiting (2017–) | child, adult | recurrent medulloblastoma, recurrent ATRT |
| NCT01174537 | 1 and 2 | oncolytic NDV | Newcastle disease virus | injection into the tumor cavity | 0 | withdrawn (2011) | adult | glioblastoma, sarcoma, neuroblastoma |
| NCT02986178 | 2 | oncolytic-poliovirus | Polio/rhinovirus recombinant (PVSRIPO) | administered intratumorally via convection-enhanced delivery using an intracerebral catheter | 122 | active, not recruiting (2017–) | adult | malignant glioma |
| NCT01156584 | 1 | retrovirus | Toca 511 vector + Toca FC | single, stereotactic, transcranial, intratumoral or intravenous injection | 54 | completed (2010–2016) | adult | glioblastoma, anaplastic astrocytoma, oligodendroglioma |
| NCT01985256 | 1 | retrovirus | Toca 511 vector + Toca FC | administered intravenously and then intracranially | 17 | completed (2014–2016) | adult | glioblastoma, anaplastic astrocytoma, oligodendroglioma |
| NCT00001328 | 1 | cell line producing retrovirus | G1TKSVNa.53 producer cell line + cytovene | intratumoral injection | 15 | completed (1992–2010) | adult | brain neoplasm |
| NCT02414165 | 2 and 3 | retrovirus | Toca 511 vector + Toca FC + lomustine + bevacizumab | injection into the tumor cavity | 403 | terminated (2015–2020) | adult | glioblastoma, anaplastic astrocytoma |