Table 4. Clinical trials with gene therapy for recurrent HGG patients.
Gene Therapy | Author (year) | Tumor Type | Phase | No. of Patients | PFS-6 (%) | Median PFS (months) | Median OS (months) |
---|---|---|---|---|---|---|---|
AdHSV-TK/GCV | Trask et al. (2000)13 | Recurrent GBM | I | 13 | N/A | N/A | 4.0 (post-GT) 20.9 (post-DX) |
Judy and Eck (2002)14 | Primary and recurrent GBM | I | 13 | N/A | 3 | 10.0 | |
Germano et al. (2003)15 | Recurrent GBM | I | 11 | N/A | N/A | 12.0 (post-GT) 22.0 (post-DX) |
|
Smitt et al. (2003)16 | Recurrent GBM | I | 14 | N/A | 2.3 | 4.0 | |
Immonen et al. (2004)8 | Primary and recurrent GBM | II Randomized |
36 (all) 17 (GT) 19 (Control) |
N/A | N/A | 62.4 weeks (GT) 55.3 weeks (GBM) |
|
Ad-p53 | Lang et al. (2003)17 | Recurrent GBM | I | 15 | 33.3% (5/15) | 13 weeks | 43 weeks |
ONYX-015 | Chiocca et al. (2004)18 | Recurrent HGG | I | 24 | N/A | 46 days | 6.2 (all) 4.9 (GBM) |
G207 | Markert et al. (2000)19 | Recurrent GBM | I | 21 | N/A | 3.5 (all, mean) | 12.8 (alive, mean) 6.2 (dead, mean) 15.9 (GBM, post-DX, mean) |
Market et al. (2009)20 | Recurrent GBM | Ib | 6 | N/A | 3.0 | 6.6 (post-GT) 23.0 (post-DX) |
|
HSV1716 | Rampling et al. (2000)21 | Recurrent MG | I | 9 | N/A | N/A Range: 2.0 ∼ 24.0 |
N/A Range: 8 weeks ∼ 24 months |
Papanastassiou et al. (2002)22 | Primary and recurrent GBM | I | 12 | N/A | N/A | greater than 7.0 Range: 1.0 ∼ 13.0 |
|
Harrow et al. (2004)23 | Primary and recurrent GBM | N/A | 12 | 50% (6/12) | N/A | N/A Range: 3.0-22.0 |
Abbreviation: PFS, progression-free survival; PFS-6, 6-month progression-free survival; OS, overall survival; MG, malignant gliomas; GBM, glioblastoma; HGG, high grade glioma; DX, diagnosis; GT, gene therapy; N/A, data not available.