NCT01091792

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)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-04-02
• Completion: 2015-04-02
• First posted: 2010-03-24
• Last updated: 2018-05-25

Locations

1 site across 1 country: United States