Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2018 |
| Start Date: | March 2010 |
| End Date: | April 2, 2015 |
DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)
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.
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.
Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor and it remains a
lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed
to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent
radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of
care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of
RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for
12 months. Blood samples will be obtained from these patients at 3 different time points
during this study.
lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed
to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent
radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of
care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of
RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for
12 months. Blood samples will be obtained from these patients at 3 different time points
during this study.
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
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