Table 3.
Phase II/III clinical trials with dendritic cells (DC) vaccines in glioblastoma.
| Clinical Trial | Phase | Loading Material for DCs | Treatment | Control | Indication | # Patients | Endpoint | Outcome |
|---|---|---|---|---|---|---|---|---|
|
NCT01567202 30159779 |
II | GSC antigens | P: SOC, DC R: SS, RT/CT, DC |
P: SOC, placebo R: SS, RT/CT, placebo |
P GB R GB |
Treatment: 22 Control: 21 |
PFS | 7.7 mo vs. 6.9 mo |
|
NCT02772094 21715171 |
I/II | Irradiated tumor cells | SOC/SS, DC | None | P GB | 16 | OS | 17 mo |
| ICT-107 NCT01280552 31320597 |
II | Multiple TAA | SOC, DC | SOC, placebo | P GB HLA-A1+ and/or -A2+ |
Treatment: 81 Control: 43 |
OS | 17.0 vs. 15.0 mo |
| DCVax-L NCT00045968 29843811 |
III | Tumor lysate | SOC, DC | SOC, placebo | P GB | 331 | (OS) | 23.1 mo |
| GBM-Vax NCT01213407 30301187 |
II | Tumor lysate | SOC, DC | SOC | P GB | 34 | PFS12 | No impact |
|
NCT03879512 30054667 |
I/II | Tumor lysate | SS, Cyclophosphamide, DC | None | R GB pediatric R GB adult |
Pediatric: 6 Adult: 5 |
OS6 | 100% |
| DEND/GM NCT01006044 28499389 |
II | Tumor lysate | SOC, DC | None | P GB | 31 | PFS | 12.7 mo |
|
NCT00576537 18632651 |
I/II | Tumor lysate | SOC/SS, DC | None | P GB R GB |
P: 11 R: 23 |
(OS) | Vaccine responders: 21 mo Nonresponders 14 mo |
|
NCT00323115 21499132 |
II | Tumor lysate | SOC, DC | None | P GB | 10 | (OS) | 28 mo |
| DENDR2 NCT02820584 |
I/II | Tumor lysate | (1) SS, TMZ, DC (2) SS, TTX, DC |
None | R GB | (1) 12 (2) 8 |
(OS) | (1) 7.4 mo (2) 9.2 mo |
| DENDR1 29632727 |
I/II | Tumor lysate | SOC, TMZ, DC | None | P GB | 24 | PFS12 | 41% |
| DC-CAST-GBM NCT00846456 23817721 |
I/II | Tumor stem cell mRNA | SOC, DC | None | P GB | 7 | (OS) | 25 mo |
Abbreviations: GSC, glioma stem cell; TAA, tumor-associated antigen; P, primary; R, recurrent; GB, glioblastoma; #, number of; SS, second surgical procedure; RT, radiotherapy; CT, chemotherapy; TTX, tetanus toxoid; OS6, 6-mo OS; PFS12, 12-mo PFS. The ‘Endpoint’ column indicates which primary survival endpoint was assessed in each clinical trial. If a study only used a secondary survival endpoint, the outcome measure was placed between parentheses.