Clinical Trial: Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas

Brief Summary:

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progression meningiomas.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the efficacy of bevacizumab in patients with recurrent or progressive benign and atypical/malignant meningiomas, despite prior therapy, as measured by six-month progression-free survival.

SECONDARY OBJECTIVES:

I. To describe the response rate and overall-survival in this patient population.

II. To evaluate the safety profile of bevacizumab in patients with recurrent meningiomas.

III. To perform an exploratory study in patients with hemangioblastoma and hemangiopericytoma.

IV. To assess tissue for VEGF and VEGFR to correlate with response. An exploratory analysis of HER-2 will be performed.

OUTLINE:

Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months. Patients may then receive bevacizumab IV every 3 weeks for up to 12 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years.

Sponsor: Northwestern University

Current Primary Outcome: Progression free survival [ Time Frame: At 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Response rate and overall-survival [ Time Frame: During week 8, every 8 weeks thereafter while on treatment and intermittently during followup ]
  Patients will have scans during week 8 and every 8 weeks thereafter while on treatment to assess response. Survival status will be confirmed intermittently during followup.
• Safety profile of bevacizumab [ Time Frame: Every 2 weeks while on treatment up to 28 days after the last dose ]
  Adverse events will be assessed every 2 weeks while on treatment up to 28 days after the last dose.
• Levels of VEGF and VEGFR expression in tumor tissue as compared to response rate [ Time Frame: At baseline and every 8 weeks until disease progression or death ]
  Tissue will be collected for the VEGF and VEGFR correlative studies during the screening phase. Patients will undergo radiological assessments every 8 weeks during treatment to determine disease status. The level of VEGF and VEGFR expression will be compared with the response rate as determined at the time of disease progression or death.

Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: May 7, 2010
Date Started: July 2010
Date Completion: July 2018
Last Updated: March 1, 2017
Last Verified: March 2017