Table 2.
Trial name | Phase | N | Experimental design | PFS (mo) | OS (mo) | References |
---|---|---|---|---|---|---|
VICTORI | I | 12 | Vaccine administered 60% sensitized | 10.2 | 22.8 | [16, 17] |
| ||||||
ACTIVATE | II | 19 | Vaccine + GM-CSF versus case matched controls | 12 | 47.7 in sensitized pts; 22.8 in nonsensitized pts | NCT00643097 [20] |
| ||||||
ACT II | II | 22 | Vaccine + high dose short course TMZ versus low dose prolonged course TMZ. Improved immune sensitization in patients with prolonged TMZ treatment | 15.2 | 23.6 | [21] |
| ||||||
ACT III | II | 65 | Vaccine + GM-CSF + TMZ versus TMZ | 12.3 | 24.6 | NCT00458601 [19] |
| ||||||
ACT IV | III | Vaccine + GM-CSF + TMZ versus TMZ and placebo alone | Ongoing | Ongoing | NCT01480479 | |
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ReACT | II | Relapsed GBM, vaccine + GM-CSF + bevacizumab versus bevacizumab | Ongoing | Ongoing | NCT01498328 | |
| ||||||
Pediatric pontine glioma pilot study | I | Children with DIPG vaccine + GM-CSF after radiation | Ongoing | Ongoing | NCT01058850 |
N: number of patients; PFS: progression-free survival; OS: overall survival.