Table 4.
Summary of oncolytic virus use in Phase I/II studies.
| Trial Name | Virus | Cancer | n | Administration, Adverse Events, Study Conclusions |
|---|---|---|---|---|
| Phase I/II trial of carboplatin and paclitaxel chemotherapy in combination with intravenous oncolytic reovirus in patients with advanced malignancies [129] (Karapanagiotou 2012). | RT3D (Reovirus Type 3 Dearing) | Advanced head and neck cancer | 31 | Study used IV infusion of RT3D with carboplatin/paclitaxel. Study reported treatment was well tolerated, no MTD, and toxicities were largely grade I/II. Outcomes reported by RECIST were 1 CR (3·8%) and 6 PR (23·1%). |
| Oncolytic H-1 parvovirus shows safety and signs of immunogenic activity in a first phase I/IIa glioblastoma trial [130] (Geletneky 2017). | Parvovirus | Glioblastoma | 18 | Study used IV and intratumoral injection into cavity created from resection. Study reported: no MTD was reached; T cell infiltration and activation of macrophages and microglia were detected in the infected tumors (Evidence that it is stimulating the immune system) Median survival increased compared to recent meta-analyses. |
| Phase I/II study of oncolytic HSV GM-CSF in combination with radiotherapy and cisplatin in untreated stage III/IV squamous cell cancer of the head and neck [131] (Harrington 2010). | HSV GM-CSF | Stage III/IV squamous cell cancer of head and neck | 17 | Study used intratumoral injection every 21 days with radiation and cisplatin; neck dissection 6–10 weeks later. Study reported a median follow up of 29 months with 76·5% relapse free rate, 100% locoregional control (60–70% in historical controls). |
| Phase I/II study of oncolytic herpes simplex virus NV1020 in patients with extensively pretreated refractory colorectal cancer metastatic to the liver [132] (Geevarghese 2010). | NV1020 (Herpes Virus) | Colorectal liver metastases | I 13 II 19 |
Study used hepatic arterial injections with virus then standard chemotherapy in patients with relapse. Study documents 50% SD with a median survival longer than historical controls. |
| Phase I–II trial of ONYX-015 in combination with MAP chemotherapy in patients with advanced sarcomas [133] (Galanis 2005). | Onyx-015 (Adenovirus dl1520) | Advanced sarcomas | 6 | Study used intratumoral injection of the virus in combination with MAP applied to metastases in the liver and chest wall. No significant toxicities identified. Study outcomes include:1 patient with PR that lasted 11 months; tumor had p53 mutation and MDM-2 amplification |
| Phase I/II trial of intravenous NDV-HUJ oncolytic virus in recurrent glioblastoma multiforme [134] (Freeman 2006). | NDV-HUJ (HUJ strain of Newcastle disease virus) | glioblastoma multiforem | 14 | Study used IV injection of virus. Study reported AEs grade I/II constitutional symptoms. 1 person with CR. |
CR, complete response; MAP, mitomycin-C+ doxorubicin+cisplatin; MTD, maximum tolerated dose; OS, overall survival; PR, partial response; RECIST, response evaluation criteria in solid tumors; SD, stable disease.