Randomized Controlled Immunotherapy Clinical Trials for GBM Challenged
Abstract
:Simple Summary
Abstract
1. Introduction
2. Current Anti-Cancer Treatment Strategies for GBM
3. Challenges for RCTs
4. Immunotherapy for GBM
5. Risk Factors and Levels of Personalized Medicine
6. Current Landscape
7. Non-Scientific Challenges
8. Individualized Multimodal Immunotherapy for GBM
9. A Case of Complete Remission and Specific T-Cell Response
10. Results in Term of OS
11. Conclusions
Author Contributions
Funding
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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1. Recursive Partitioning Analysis (RPA) clinical classification
4. Tumor–host immune reaction
|
1. Molecular biology of tumor
6. Immunotherapy components
|
Label | Phase | Number of Patients | Randomized | Status | Primary Outcome | Estimated Study Completion |
---|---|---|---|---|---|---|
NCT00576537 | 2 | 50 | No | Completed | Safety/Toxicity | 10/2011 |
NCT02649582 | 1 + 2 | 20 | No | Recruiting | OS, Safety/Toxicity Feasibility | 12/2020 |
NCT00846456 | 1 + 2 | 20 | No | Completed | Toxicity, Immune response | 02/2013 |
NCT00323115 | 2 | 11 | No | Completed | Immune response, Toxicity, PFS | 07/2013 |
NCT02366728 | 2 | 100 | RCT | Active, not recruiting | OS, DC migration | 08/2020 |
NCT01204684 | 2 | 60 | RCT | Active, not recruiting | PFS, OS | 01/2021 |
NCT03927222 | 2 | 48 | No | Recruiting | OS, DC migration | 12/2023 |
NCT01006044 | 2 | 26 | No | Completed | PFS, Toxicity | 08/2014 |
NCT03395587 | 2 | 136 | RCT | Recruiting | OS, PFS | 06/2023 |
NCT04523688 | 2 | 28 | No | Not recruiting | PFS | 12/2025 |
NCT03548571 | 2 + 3 | 60 | RCT | Recruiting | PFS, OS | 05/2023 |
NCT04115761 | 2 | 24 | RCT | Recruiting | PSF | 06/2022 |
NCT03014804 | 2 | 0 | RCT | Withdrawn | ||
NCT03879512 | 1 + 2 | 25 | No | Recruiting | OS, PFS | 01/2022 |
NCT02772094 | 2 | 50 | No | Unknown | OS, Toxicity | 12/2016 |
NCT01567202 | 2 | 100 | RCT | Recruiting | Response, PFS, OS | 02/2020 |
NCT01213407 | 2 | 87 | RCT | Completed | PFS, OS | 11/2015 |
NCT01291420 | 1 + 2 | 10 | No | Unknown | Immune response | Unknown |
NCT02465268 | 2 | 120 | RCT | Recruiting | OS, Immune response, PFS | 06/2024 |
NCT04277221 | 3 | 118 | RCT | Recruiting | OS, PFS | 12/2022 |
NCT00323115 | 2 | 11 | No | Completed | T-cell response | 07/2013 |
NCT03400917 | 2 | 55 | No | Completed | OS | 02/2023 |
NCT02546102 | 3 | 414 | RCT | Suspended | OS | 12/2021 |
NCT01280552 | 2 | 124 | RCT | Completed | OS | 12/2015 |
NCT00045968 | 3 | 348 | RCT | Unknown | PFS | 11/2016 |
NCT03688178 | 2 | 112 | RCT | Recruiting | OS, Varlimumab safety, Treg level | 03/2025 |
NCT01759810 | 2 + 3 | 60 | No | Enrolling by invitation | OS | 12/2020 |
NCT02754362 | 2 | No | Withdrawn | Immune response | 06/2019 | |
NCT04388033 | 1 + 2 | 10 | No | Recruiting | Safety, PFS | 12/2023 |
Vaccine | Local Hyperthermia | NDV | DC Total | DC/Vaccine | |
---|---|---|---|---|---|
N | 69 | 70 | 69 | 70 | 112 |
Minimum | 0 | 0 | 0 | 0 | 2,400,000 |
25%P | 1 | 13 | 17 | 6,950,000 | 8,075,000 |
Median | 2 | 25 | 30 | 20,115,000 | 12,200,000 |
75% | 2 | 42 | 42 | 34,200,000 | 19,145,000 |
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Share and Cite
Van Gool, S.W.; Makalowski, J.; Fiore, S.; Sprenger, T.; Prix, L.; Schirrmacher, V.; Stuecker, W. Randomized Controlled Immunotherapy Clinical Trials for GBM Challenged. Cancers 2021, 13, 32. https://doi.org/10.3390/cancers13010032
Van Gool SW, Makalowski J, Fiore S, Sprenger T, Prix L, Schirrmacher V, Stuecker W. Randomized Controlled Immunotherapy Clinical Trials for GBM Challenged. Cancers. 2021; 13(1):32. https://doi.org/10.3390/cancers13010032
Chicago/Turabian StyleVan Gool, Stefaan W., Jennifer Makalowski, Simon Fiore, Tobias Sprenger, Lothar Prix, Volker Schirrmacher, and Wilfried Stuecker. 2021. "Randomized Controlled Immunotherapy Clinical Trials for GBM Challenged" Cancers 13, no. 1: 32. https://doi.org/10.3390/cancers13010032