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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091792
Recruitment Status : Active, not recruiting
First Posted : March 24, 2010
Last Update Posted : August 19, 2016
Genentech, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Bevacizumab Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : March 2010
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bevacizumab
Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide
Drug: Bevacizumab
Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy
Other Name: Avastin

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091792

United States, New Hampshire
Dartmouth Hithcock Medcial Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Genentech, Inc.
Principal Investigator: Camilo E Fadul, MD Dartmouth-Hitchcock Medical Center

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01091792     History of Changes
Other Study ID Numbers: D0947
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
Grade IV

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents