Table 5.
Clinical trials on suicide gene therapies for high-grade gliomas.
| # | ClinicalTrials.gov Identifier | Title | Status | Phase | Diseases | # of Pts. Enrolled | Treatment | Locations |
|---|---|---|---|---|---|---|---|---|
| 1 | NCT00870181 | ADV-TK Improves Outcome of Recurrent High-Grade Glioma | Completed | II | Malignant Glioma of Brain Glioblastoma |
47 | Biological: ADV-TK/GCV Procedure: Surgery Drug: systemic chemotherapy |
CHN |
| 2 | NCT00002824 | Gene Therapy in Treating Patients with Primary Brain Tumors | Completed | I | Brain and Central Nervous System Tumors | NA | Biological: gene therapy Drug: chemotherapy, ganciclovir Procedure: conventional surgery |
USA |
| 3 | NCT00751270 | Phase 1b Study of AdV-tk + Valacyclovir CombinedWith Radiation Therapy for Malignant Gliomas | Completed | I | Malignant Glioma Glioblastoma Multiforme Anaplastic Astrocytoma |
15 | Biological: AdV-tk Drug: Valacyclovir |
USA |
| 4 | NCT03596086 | HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM | Recruiting | I/II | Glioblastoma Multiforme Astrocytoma, Grade III |
62 | Drug: ADV/HSV-tk (gene therapy) | USA |
| 5 | NCT00634231 | A Phase I Study of AdV-tk + Prodrug Therapy in Combination with Radiation Therapy for Pediatric Brain Tumors | Active, not recruiting |
I | Malignant Glioma Recurrent Ependymoma |
12 | Biological: AdV-tk Drug: valacyclovir Radiation: Radiation |
USA |
| 6 | NCT00589875 | Phase 2a Study of AdV-tk with Standard Radiation Therapy for Malignant Glioma (BrTK02) |
Completed | II | Malignant Glioma Glioblastoma Multiforme Anaplastic Astrocytoma |
52 | Biological: AdV-tk Drug: Valacyclovir |
USA |
| 7 | NCT03603405 | HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM | Recruiting | I/II | Glioblastoma Anaplastic Astrocytoma |
62 | Drug: ADV/HSV-tk (gene therapy) | USA |
| 8 | NCT00001328 | Gene Therapy for the Treatment of Brain Tumors | Completed | I | Brain Neoplasm Neoplasm Metastasis |
15 | Drug: Cytovene (Ganciclovir Sodium) Device: G1TKSVNa.53 Producer Cell Line | USA |
| 9 | NCT03576612 | GMCI, Nivolumab, and Radiation Therapy in Treating Patients with Newly Diagnosed High-Grade Gliomas |
Active, not recruiting |
I | Glioma, Malignant | 36 | Biological: AdV-tk, Nivolumab Drug: Valacyclovir, Temozolomide; Radiation |
USA |
| 10 | NCT01985256 | Study of a Retroviral Replicating Vector Given Intravenously to Patients Undergoing Surgery for Recurrent Brain Tumor |
Completed | I | Glioblastoma Multiforme Anaplastic Astrocytoma Anaplastic OligodendrogliomaAnaplastic Oligoastrocytoma |
17 | Biological: Toca 511 Drug: Toca FC |
USA |
| 11 | NCT01156584 | A Study of a Retroviral Replicating Vector Combined with a Prodrug Administered to Patients with Recurrent Malignant Glioma | Completed | I | Glioblastoma Anaplastic Astrocytoma Anaplastic OligodendrogliomaAnaplastic Oligoastrocytoma |
54 | Biological: Toca 511Drug: Toca FC | USA |
| 12 | NCT01174537 | New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma |
Withdrawn | I/II | Glioblastoma Sarcoma Neuroblastoma |
0 | Biological: New Castle Disease Virus | IL |
| 13 | NCT01470794 | Study of a Retroviral Replicating Vector Combined with a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor | Completed | I | Glioblastoma Multiforme Anaplastic Astrocytoma Anaplastic OligodendrogliomaAnaplastic Oligoastrocytoma |
58 | Biological: Toca 511 Drug: Toca FC |
USA |
| 14 | NCT00390299 | Viral Therapy in Treating Patients with Recurrent Glioblastoma Multiforme |
Completed | I | Anaplastic Astrocytoma Anaplastic Oligodendroglioma Mixed Glioma Recurrent Glioblastoma |
23 | Biological: Carcinoembryonic Antigen-Expressing Measles Virus; Therapeutic Conventional Surgery | USA |
| 15 | NCT02414165 | The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Carec in Patients with Recurrent High-Grade Glioma | Terminated | II/III | Glioblastoma Multiforme Anaplastic Astrocytoma |
403 | Biological: Toca 511, Bevacizumab; Drug: Toca FC; Drug: Lomustine, Temozolomide | USA |
| 16 | NCT01811992 | Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma | Active, not recruiting |
I | Malignant Glioma Glioblastoma Multiforme |
19 | Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L | USA |
| 17 | NCT02598011 | A Study of the Safety of Toca 511, a Retroviral Replicating Vector, Combined with Toca FC in Subjects with Newly Diagnosed High Grade Glioma Receiving Standard of Care | Withdrawn | I | Newly Diagnosed High Grade Glioma (HGG) | 0 | Biological: Toca 511 Drug: Toca FC |
NA |
| 18 | NCT04406272 | VB-111 in Surgically Accessible Recurrent/Progressive GBM | Recruiting | II | Glioblastoma Recurrent Glioblastoma |
45 | Drug: VB11 Procedure: Surgery Drug: Bevacizumab |
USA |
CHN: China; CMV: Citomegalovirus; GBM: Glioblastoma Multiforme; GCV: Ganciclovir; IL: Israel; NA: Not Available; Pts: Patients; XRT: Radiotherapy.