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

NCT ID: NCT01091792

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-04-02

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy

Interventions

Bevacizumab

Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lionel.D.Lewis, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camilo E Fadul, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hithcock Medcial Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D0947

Identifier Type: -

Identifier Source: org_study_id