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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:
Collaborator:
Genentech
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
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015300

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

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01015300     History of Changes
Other Study ID Numbers: D0904
Study First Received: November 16, 2009
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013