Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)

• Status: Completed
• Trial end date: 2015-04-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Endothelial Growth Factors

Criteria

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