Table 2.
Characteristics of imposing phase II clinical trials for GBM.
| First author/Published year | Patients status (number) | Intervention (number) | Comparison (number) | Results | Study design |
|---|---|---|---|---|---|
| Giuseppe Lombardi et al., (28) | Recurrent GBM (119) | RT + TMZ + Regorafenib (59) | RT + TMZ + LOM (60) | Regorafenib: OS: 7.4m, 12-month overall survival rate: 38.9%;LOM: OS: 5.6m, 12-month overall survival rate: 15.0%; | Phase II, randomized (REGOMA) |
| Jaishri O. Blakeley et al., (29) | Newly diagnosed GBM (81) | RT + TMZ + Iniparib (81) | Historical control(the EORTC/NCIC phase III trial)17,40,41 | The mOS was 21.6m, 2-year and 3-year survival rates are 38.3% and 24.7%;OS: MGMT promoter methylated: 30m; MGMT promoter unmethylated: 15.8m; MGMT promoter methylated status unknown: 25.9m. | Phase II, single arm |
| Xiao-Tang Kong et al., (30) | Newly diagnosed GBM (24) | RT + TMZ + Bortezomib (24) | Historical control2,6,48 | mPFS: 6.2m; 6-month PFS rate: 54.2%;mOS: 19.1m (MGMT promoter methylated: 61m; MGMT promoter unmethylated: 16.4m) | Phase II, single arm |
| Thomas Kaley et al., (31) | Glioma patients with BRAFV600E mutation, including high grade glioma (24) | Vemurafenib (24) | Historical control | For the GBM and anaplastic astrocytoma cohort, the PFS and OS were 5.3m and 11.9m.Vemurafenib has clinical meaningful activity in glioma patients with BRAFV600E mutation. | Phase II, multi-cohort |
| Timothy Cloughesy et al., (32) | First recurrent, after chemoradiotherapy, bevacizumab-naïve patients with GBM (129) | Ona + BEV (64) | Placebo + BEV (65) | Ona + BEV: PFS: 3.9m, OS: 8.8m;Placebo + BEV: PFS: 2.9m, OS: 12.6m;In unselected patients with recurrent GBM, there was no evidence of further clinical benefit of Ona + BEV compared with BEV plus placebo. | Phase II, randomized |
| Wolfgang Wick et al., (33) | GBM patients at first or second progression (91) | rRT + APG101/CAN008 (58) | rRT (26) | rRT + APG101/CAN008: 6m PFS rate: 20.7%;rRT: 6m PFS rate: 3.8%;Methylation levels at CpG2 in the CD95L promoter in the tumor was concerned as a potential biomarker. | Phase II, randomized |
| Isabel Arrillage Romany (34) | Recurrent GBM, BEV-naïve, IDH1/2 wild type (17) | ONC monotherapy (17) | Historical meta-analyses77-79 | Median OS was 41.6 weeks, 6m OS was 71%, 9m OS was 53%, 6m PFS was 11.8%. | Phase II, single arm |
| Reena P. Thomas (35) | Newly diagnosed GBM (29) | RT + TMZ + Plerixafor (29) | Historical control2 | Median OS was 21.3m, median PFS was 14.5m. The drug was well-tolerated and no serious adverse effect was found in this trial. |
Phase I/II, single arm |
GBM, glioblastoma; RT, radiotherapy; rRT, reradiotherapy; TMZ, temozolomide; LOM, lomustine; OS, overall survival; mOS, median overall survival; PFS, progression free survival; mPFS, median progression free survival; MGMT, O6-Methylguanine-DNA Methyltransferase; Ona, onartuzumab; EGFR, epidermal growth factor receptor; m, month(s).