Bevacizumab for Recurrent Malignant Glioma

Conditions

• Malignant Gliomas
• Recurrent High-Grade Gliomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jan 2, 2006

Start date

Dec 31, 2005

Status verified

Apr 2014

Primary completion

Mar 31, 2011

Completion

Feb 28, 2014

Study Design

Enrollment

88 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Anaplastic Glioma (AG)
  Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified) 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.
• Other: Glioblastoma Multiforme (GBM)
  Glioblastoma multiforme Gliosarcoma 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.

Primary Outcome Measure

Percentage of Participants With Progression Free Survival at 6 Months. [ Time Frame: 6 months ]

Locations (1)

Find similar trials in Bethesda, MD