Table 1 Ongoing clinical trials for gene therapy of GBM
Type of gene therapy | Phase | Vector | Gene | Prodrug | Nation | ID | Title |
|---|---|---|---|---|---|---|---|
Suicide | Pilot | NSC | CD | 5-FC | USA | NCT01172964 | A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E. Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas |
Suicide | I | AV | HSV-TK | Valacyclovir | USA | NCT00751270 | Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas |
Suicide/immune-mediated | I | AV | HSV-TK | Valacyclovir | USA | NCT01811992 | Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma |
AV | Flt3L | - | |||||
Suicide | I | RV (Toca 511) | CD | 5-FC | USA | NCT01470794 | Study of a Retroviral Replicating Vector to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor |
Suicide | I | RV (Toca 511) | CD | 5-FC | USA | NCT01985256 | Study of a Retroviral Replicating Vector Given Intravenously to Patients Undergoing Surgery for Recurrent Brain Tumor |
Suicide | I | AV | HSV-TK | Valacyclovir | USA | NCT00634231 | A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors |
Suicide | I/II | RV (Toca 511) | CD | 5-FC | USA | NCT01156584 | A Study of a Retroviral Replicating Vector Administered to Subjects With Recurrent Malignant Glioma |
Suicide | II | AV | HSV-TK | Valacyclovir | USA | NCT00589875 | Phase 2a Study of AdV-tk With Standard Radiation Therapy for Malignant Glioma (BrTK02) |
Oncolytic | I | HSV (HSV1716) | - | - | USA | NCT02031965 | Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery |
Oncolytic | I | MV | CEA | - | USA | NCT00390299 | Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme |
Oncolytic | I | AV (DNX-2401) | - | - | Spain | NCT01956734 | Virus DNX2401 and Temozolomide in Recurrent Glioblastoma |
Oncolytic | I | PoV (PVS-RIPO) | - | - | USA | NCT01491893 | Poliovirus Vaccine for Recurrent Glioblastoma Multiforme (GBM) |
Oncolytic | I | AV (DNX-2401) | - | - | USA | NCT00805376 | DNX-2401 (Formerly Known as Delta-24-RGD-4C) for Recurrent Malignant Gliomas |
Oncolytic | I/II | HSV (G47Delta) | LacZ | - | Japan | JPRN-UMIN000002661 | A Clinical Study of a Replication-Competent, Recombinant Herpes Simplex Virus Type 1 (G47delta) in Patients With Progressive Glioblastoma |
Oncolytic | I/II | PaV (H-1 PV) | - | - | Germany | NCT01301430 | Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme |
Oncolytic | I/II | AV (Delta24-RGD) | - | - | Netherlands | NCT01582516 | Safety Study of Replication-competent Adenovirus (Delta-24-rgd) in Patients With Recurrent Glioblastoma |
Oncolytic | I/II | AV (Delta24-RGD) | - | - | Netherlands | EUCTR2007-001104-21-NL | A Phase I/II Trial of a Conditionally Replication-Competent Adenovirus (delta-24-rgd) Administered Convection Enhaced Delivery in Patients With Recurrent Glioblastoma Multiforme |
*Suicide | I | NSC | CD | 5-FC | USA | NCT02015819 | Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin Calcium in Treating Patients With Recurrent High-Grade Gliomas |
*Oncolytic | I/II | NDV | - | - | Israel | NCT01174537 | New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma |
*Oncolytic/immune-mediated | I | HSV (M032) | IL-2 | - | USA | NCT02062827 | Genetically Engineered HSV-1 Phase 1 Study |