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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Camilo E Fadul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Institutional Review Board

Study ID:

D0947

NCT ID:

NCT01091792

Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma Multiforme
  • GBM
  • Grade IV
  • glioma
  • Glioblastoma

Name

Location
Dartmouth Hithcock Medcial Center Lebanon, New Hampshire  03756