Clinical trial · Interventional
Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)
DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)
NCT01091792CI-TRIAL-00033093completedEarly Phase 1ClinicalTrials.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)
Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab
- description
- Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Changes in the peripheral blood T-reg profile between pretreatment and 4 weeks after completion of treatment with the addition of bevacizumab to RT and TMZ in patients with glioblastoma
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Immunologic shift in the phenotypic T cell, B cell, NK cell and DC repertoire induced by RT-TMZ-BEV comparing pretreatment and 4 weeks after completion of treatment
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven GBM * Karnofsky status equal to or greater than 60% Exclusion Criteria: * Inadequately controlled hypertension * Prior history of hypertension crisis or hypertensive encephalopathy * History of stroke or transient ischemic attach within 12 months
References
Publications (0)
Data not yet available
No reference posted for this study.