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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dartmouth Hithcock Medcial Center
Lebanon, New Hampshire, United States
Start Date
March 1, 2010
Primary Completion Date
April 2, 2015
Completion Date
April 2, 2015
Last Updated
May 25, 2018
13
ACTUAL participants
Bevacizumab
DRUG
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07100730