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

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT01091792
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 24, 2010
Start date
Mar 31, 2010
Status verified
May 2018
Primary completion
Apr 2, 2015
Completion
Apr 2, 2015

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Bevacizumab
    Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Primary 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 [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth Hithcock Medcial CenterLebanonNew Hampshire03756-

Find similar trials in Lebanon, NH

By research site
Dartmouth Hithcock Medcial Center· Lebanon, NH

Related Studies