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

This study has been terminated.
(Study terminated due to low accrual.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01015300
First received: November 16, 2009
Last updated: May 9, 2012
Last verified: May 2012

November 16, 2009
May 9, 2012
December 2009
October 2011   (final data collection date for primary outcome measure)
Radiographic response in the size of the hemangioblastoma on magnetic resonance imaging (MRI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01015300 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bevacizumab (Avastin) in Unresectable/Recurrent Hemangioblastoma From Von-Hippel-Lindau Disease
D0904 - A Pilot Study of Bevacizumab (Avastin) in Patients With Unresectable or Recurrent Hemangioblastoma From Von Hippel-Lindau Disease.

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.

Not Provided
Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hemangioblastomas
  • Von Hippel Lindau Disease
Drug: Avastin
Patients will receive Bevacizumab (Avastin) 10mg/kg IV every two weeks for 6 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • One or more CNS hemangioblastomas not amendable to surgical resection or recurrent post resection
  • Confirmed diagnosis of von-Hippel-Lindau disease
  • No prior treatment with VEGF inhibitors
  • Index hemangioblastomas lesion at least 5mm on MRI
  • No major bleeding event from hemangioblastoma within 90 days
  • KPS > or equal to 60%
  • Age > or equal to 18 years

Exclusion Criteria:

  • Prior treatment with VEGF inhibitors
  • Major bleeding event from hemangioblastoma within 90 days
  • Inability to comply with study and/or follow up procedures
  • Life expectancy of less than 12 weeks
  • Current or recent (within 4 weeks of the first infusion of this study) participation in an experimental drug study other than a Genentech sponsored bevacizumab cancer study
  • Active malignancy will be permissible if treating physician deems that concurrent administration of bevacizumab is not contraindicated and that the patient would be able to complete with the other parameters of the protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01015300
D0904
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Genentech, Inc.
Principal Investigator: J Marc Pipas, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP