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

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bevacizumab

About this trial

This is an interventional basic science trial for Glioblastoma Multiforme focused on measuring GBM, Grade IV, glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dartmouth Hithcock Medcial Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01091792

First Posted

March 22, 2010

Last Updated

May 24, 2018

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01091792

Brief Title

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

Official Title

DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2, 2015 (Actual)

Study Completion Date

April 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

Keywords

GBM, Grade IV, glioma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab

Arm Type

Experimental

Arm Description

Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camilo E Fadul, MD

Organizational Affiliation

Dartmouth-Hitchcock Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dartmouth Hithcock Medcial Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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