Table 2. Design and outcome of completed and ongoing clinical trials of oncolytic virotherapy in patients with malignant gliomas.
Virus (strain) [Ref] |
Study phase |
# of Patients |
Application protocol | Efficacy | Toxicity |
---|---|---|---|---|---|
HSV G207 42 |
I | 21 | 1×106 –3×109pfu single IT injection | Decreased tumor volume on MRI in 8 patients | No toxicity, no serious adverse events |
HSV G207 131 |
I | 6 | Two doses, totaling 1.5×109 pfu/intratumoral injections pre- and post-resection | Not efficient | transient fever, delirium, and hemiparesis in one patient that resolved with DXM treatment |
HSV G207 |
I | 9 | Two doses, totaling 1×109 pfu/intratumoral injections followed by radiotherapy on the next day | N/A | N/A |
HSV 1716 43 |
II | 9 | 103–105 pfu single IT injection | 3 responders 5 stable disease | No toxicity, no serious adverse events |
HSV 1716 132 |
I | 12 | 105 pfu single IT injection | Not assessed | No toxicity, no serious adverse events |
HSV 1716 133 | I | 12 | 105 pfu single IT injection | 3 disease free for 15–22 months | No toxicity, no serious adverse events |
HSV 1716 |
II | N/A | N/A | N/A | N/A |
HSV G47Δ |
I | “21” | N/A | N/A | N/A |
HSV M032 |
I | N/A | N/A | N/A | N/A |
AdV ONYX-015 55 |
I | 24 | 107– 1010pfu single injection to tumor resection cavity | Not efficient | No toxicity, no serious adverse events |
AdV Delta24-RGD |
I | N/A | N/A | N/A | N/A |
ReoV 75 |
I | 12 | 107– 1010 pfu single intratumoral injection (to 3 dfferent foci) | 1 long term (>6years) survivor | No grade III or IV adverse events |
ReoV | I | 18 | Convection enhanced delivery of 108–1010 TCID50 |
1 partial response 3 stable disease |
No toxicity, no serious adverse events |
NDV HUJ 71 |
I/II | 14 | Part A: 108 – 1010 IU i.v. daily for 5 days each Part B: 3 cycles 5.5×109 IU i.v. |
1 complete response 3 longterm survivors |
No toxicity, no serious adverse events |
NDV HUJ |
I/II | “30” | 1010 IU i.v. daily | N/A | N/A |
NDV MTH-68 69 |
CS | 1 | Daily intravenous injection of 2×107 to 2.5×108 pfu for years | Tumor shrinkage | No toxicity, no serious adverse events |
NDV MTH-68 70 |
CS | 4 | Daily intravenous injection of 2×107 to 2.5×108 pfu for years | 4 long term survivors | No toxicity, no serious adverse events |
NDV MTH-68 134 |
CS | 1 | Daily intravenous injection of 2×107 to 2.5×108 pfu for years | Tumor shrinkage | No toxicity, no serious adverse events |
Measles MV-CEA |
I | “40” | Intratumoral injection | N/A | N/A |
H1 H1PV |
I | “19” | Intratumoral injection prior to resection | N/A | N/A |
Polio PVS-RIPO |
I | N/A | Convection enhanced intratumoral injection prior to resection | N/A | N/A |
Abbreviations: HSV, herpes simplex virus; AdV, adenovirus; ReoV, reovirus, NDV, Newcastle disease virus; H1, rat H1 parvovirus, CS, case study/series; IT, intratumoral; i.v., intravenous; IU, infectious units; pfu, plaque forming units; TCID, tissue culture infective dose.