CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Bevacizumabdrug
Likely dose
Bevacizumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00271609
NCT00271609Phase 2Completed

A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas

National Cancer Institute (NCI)·interventional·Posted Jan 2, 2006·Updated Apr 29, 2014

In Brief

A Phase 2 clinical trial evaluating Bevacizumab for Recurrent High-Grade Gliomas and Malignant Gliomas. Completed, enrolled 88 participants across 1 site.

Detailed Summary

Background: Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor. Bevacizumab is approved for treating colorectal cancer and has shown activity against brain tumor cells in laboratory and animal tests. Objectives: To examine the safety and side effects of bevacizumab in patients with recurrent brain tumors. To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors. Eligibility: Patients 18 years of age and older with a brain tumor that continues to grow after receiving standard treatments. Design: Patients complete the following procedures during the study: * Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles. * Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end of the first treatment cycle, and as needed after that. * Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96 hours after the first dose of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood for research is collected at the time of each MRI scan to look at specific cells. * Physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks. * Quality-of-life questionnaires every 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2, 2006
Enrollment StartDec 1, 2005
Primary CompletionMar 1, 2011
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.5 years ago

Interventions

Bevacizumabdrug

10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.