NCT01091792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2015

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

5.1 years

First QC Date

March 22, 2010

Last Update Submit

May 24, 2018

Conditions

Glioblastoma Multiforme

Keywords

GBMGrade IVglioma

Outcome Measures

Primary Outcomes (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

    1 year

Secondary Outcomes (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

    1 year

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Drug: Bevacizumab

Interventions

BevacizumabDRUG

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

Also known as: Avastin
Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven GBM
  • Karnofsky status equal to or greater than 60%

You may not qualify if:

  • Inadequately controlled hypertension
  • Prior history of hypertension crisis or hypertensive encephalopathy
  • History of stroke or transient ischemic attach within 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hithcock Medcial Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

GlioblastomaGlioma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Camilo E Fadul, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

April 2, 2015

Study Completion

April 2, 2015

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations

US(1)