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

This study has been terminated.
(Study terminated due to low accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01015300
First Posted: November 18, 2009
Last Update Posted: May 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
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.

Condition Intervention Phase
Hemangioblastomas Von Hippel Lindau Disease Drug: Avastin Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: D0904 - A Pilot Study of Bevacizumab (Avastin) in Patients With Unresectable or Recurrent Hemangioblastoma From Von Hippel-Lindau Disease.

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Avastin
    Patients will receive Bevacizumab (Avastin) 10mg/kg IV every two weeks for 6 months
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015300


Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Genentech, Inc.
Investigators
Principal Investigator: J Marc Pipas, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01015300     History of Changes
Other Study ID Numbers: D0904
First Submitted: November 16, 2009
First Posted: November 18, 2009
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by Dartmouth-Hitchcock Medical Center:
Hemangioblastoma
Von Hippel Lindau
VHL
lesion
EGFR

Additional relevant MeSH terms:
Von Hippel-Lindau Disease
Hemangioblastoma
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases
Hemangioma, Capillary
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents