Clinical trial · Interventional
Dendritic Cell Cancer Vaccine for High-grade Glioma
First Line Standard Therapy of Glioblastoma Multiforme With or Without add-on Treatment With Trivax, an Anti-tumour Immune Therapy Based on Tumour-lysate Charged Dendritic Cells
NCT01213407CI-TRIAL-00022282GBM-VaxcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group receiving standard therapy with Temozolomide and radiotherapy only; after tumour resection of at least 70% in both groups. The hypothesis is based on the assumption that time to progression will be doubled in the treatment group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide, Surgery, Radiotherapy | Drug | — | UNRESOLVED |
| Trivax, Temozolomide, Surgery, Radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard therapy plus Trivax
- description
- Standard therapy with Surgery, Temozolomide, and Radiotherapy; plus Trivax, 5x10e6 autologous interleukine-12 secreting dendritic cells charged with autologous tumour lysate.
- interventionNames
- Drug: Trivax, Temozolomide, Surgery, Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Standard therapy
- description
- Surgery, Temozolomide, Radiotherapy
- interventionNames
- Drug: Temozolomide, Surgery, Radiotherapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female or male, paediatric or adult patients of 3 to 70 years of age at time of diagnosis that qualify for standard treatment including surgery, Temozolomide and radiotherapy. * GBM (WHO IV), confirmed by histology. * Total, subtotal, or partial resection of more then 70% of tumour mass defined by MRI. * Supratentorial tumour localisation. * ECOG performance status 0, 1, or 2 (for study patients older 18 years). * Life expectancy of at least 12 weeks by assessment of the attending physician. * Written informed consent of patient and/or legal guardian in case of children or adolescents. Exclusion Criteria: * Less than 100 µg of tumour protein obtained from the resected tissue. * Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study, e.g. in another therapeutic phase I, II, or III study. * Positive pregnancy test or breast-feeding. * Patients unwilling to perform a save method of birth control. * Known hypersensitivity to temozolomide. * HIV positivity.
References
Publications (6)
- BACKGROUNDDohnal AM, Graffi S, Witt V, Eichstill C, Wagner D, Ul-Haq S, Wimmer D, Felzmann T. Comparative evaluation of techniques for the manufacturing of dendritic cell-based cancer vaccines. J Cell Mol Med. 2009 Jan;13(1):125-35. doi: 10.1111/j.1582-4934.2008.00304.x. Epub 2008 Mar 17. PMID 18363835
- BACKGROUNDDohnal AM, Witt V, Hugel H, Holter W, Gadner H, Felzmann T. Phase I study of tumor Ag-loaded IL-12 secreting semi-mature DC for the treatment of pediatric cancer. Cytotherapy. 2007;9(8):755-70. doi: 10.1080/14653240701589221. Epub 2007 Oct 4. PMID 17917887
- BACKGROUNDFelzmann T, Huttner KG, Breuer SK, Wimmer D, Ressmann G, Wagner D, Paul P, Lehner M, Heitger A, Holter W. Semi-mature IL-12 secreting dendritic cells present exogenous antigen to trigger cytolytic immune responses. Cancer Immunol Immunother. 2005 Aug;54(8):769-80. doi: 10.1007/s00262-004-0637-2. Epub 2005 Jan 13. PMID 15647926
- BACKGROUNDHuttner KG, Breuer SK, Paul P, Majdic O, Heitger A, Felzmann T. Generation of potent anti-tumor immunity in mice by interleukin-12-secreting dendritic cells. Cancer Immunol Immunother. 2005 Jan;54(1):67-77. doi: 10.1007/s00262-004-0571-3. PMID 15693141
- BACKGROUNDMichael Dohnal A, Luger R, Paul P, Fuchs D, Felzmann T. CD40 ligation restores type 1 polarizing capacity in TLR4-activated dendritic cells that have ceased interleukin-12 expression. J Cell Mol Med. 2009 Aug;13(8B):1741-1750. doi: 10.1111/j.1582-4934.2008.00584.x. PMID 20187300
- BACKGROUNDTraxlmayr MW, Wesch D, Dohnal AM, Funovics P, Fischer MB, Kabelitz D, Felzmann T. Immune suppression by gammadelta T-cells as a potential regulatory mechanism after cancer vaccination with IL-12 secreting dendritic cells. J Immunother. 2010 Jan;33(1):40-52. doi: 10.1097/CJI.0b013e3181b51447. PMID 19952957