This trial is active, not recruiting.

Condition glioblastoma multiforme
Treatment bevacizumab
Phase phase 0
Target VEGF
Sponsor Dartmouth-Hitchcock Medical Center
Collaborator Genentech, Inc.
Start date March 2010
End date August 2012
Trial size 11 participants
Trial identifier NCT01091792, D0947


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide
bevacizumab Avastin
Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator Camilo E Fadul, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center.