Table 1.
Clinical gene therapy trials for mesothelioma.
| Phase study | Vector | Expressed gene | Patient number | Virus titer used [reference] |
|---|---|---|---|---|
| Pilot | Vaccinia | Interleukin-2 | 6 | Not reported [30]1 |
| Pilot | Ad | IFN-α2b | 9 | 3 × 1011–1 × 1012 vp [33]2 |
| I | Ad | HSV-TK | 13 21 |
5 × 1010–5 × 1012 vp 1.5 × 1013–5 × 1013 vp [29]3 |
| I | Ad | IFN-β | 8 | 9 × 1011–3 × 1012 vp [31]4 |
| I | Ad | IFN-β | 10 | 3 × 1011–3 × 1012 vp [32]5 |
1Intratumoral injection. The transgene expression was observed despite antivaccinia antibody generated.
2Twice intrapleural injections of E1/E3-deleted Ad at 3-day interval. One case showed more than 50% tumor reduction which was judged with a radiographic assessment on day 64. vp: virus particle.
3A single intrapleural injection of either E1/E3-deleted or E1/E4-deleted Ad. Two long-term survivors (more than 6.5 years) were included in the E1/E4-deleted Ad-injected group.
4A single intrapleural injection of E1/E3-deleted Ad. Maximum tolerance dose was judged as 9 × 1011 vp. Polymerase chain reaction detected the viral shedding in serum up to day 4 and in pleural fluid up to day 42.
5Twice intrapleural injections of E1/E3-deleted Ad at 7-day interval. No maximum tolerance dose was reached. Neutralizing antibody was generated until day 7.