Clinical Trial: Bevacizumab (Avastin) in Unresectable/Recurrent Hemangioblastoma From Von-Hippel-Lindau Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: D0904 - A Pilot Study of Bevacizumab (Avastin) in Patients With Unresectable or Recurrent Hemangioblastoma From Von Hippel-Lindau Disease.

Brief Summary: Von Hippel-Lindau (VHL) disease is an inherited syndrome manifested by a variety of benign and malignant tumors. Hemangioblastomas are the most common lesion associated with VHL disease affecting 60-84% of patients with a mean age at diagnosis of 29 years. Standard treatment for this disease is by surgery or radiotherapy. No approved systemic therapy yet exists. Patients with VHL have an increased growth factor production, specifically vascular endothelial growth factor (VEGF), resulting in angiogenesis (growth of blood vessels). Studies show that Bevacizumab inhibits the growth of VEGF protein and will block the VEGF-driven angiogenesis and result in stabilization and regression of hemangioblastomas in VHL disease patients. The dose of bevacizumab will be 10 mg/kg every two weeks for up to 6 months.

Detailed Summary:
Sponsor: Dartmouth-Hitchcock Medical Center

Current Primary Outcome: Radiographic response in the size of the hemangioblastoma on magnetic resonance imaging (MRI) [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in VEGF with bevacizumab treatment assist in the predication of radiographic response. Products of the HIF-1A synthesis pathway: plasma VEGF, PDGF, TGF-a and erythropoietin. [ Time Frame: 24 months ]

Original Secondary Outcome: Same as current

Information By: Dartmouth-Hitchcock Medical Center

Dates:
Date Received: November 16, 2009
Date Started: December 2009
Date Completion:
Last Updated: May 9, 2012
Last Verified: May 2012