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

Early Phase 1

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01091792
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2015-04-02
• Study Completion: 2015-04-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Primary Outcome Measures

Name	Time	Method
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	1 year

Secondary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (1)

Dartmouth Hithcock Medcial Center; 🇺🇸 Lebanon, New Hampshire, United States