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

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Brief Title

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

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.
    


Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Radiographic response in the size of the hemangioblastoma on magnetic resonance imaging (MRI)

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.

Condition

Hemangioblastomas

Intervention

Avastin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

December 2009

Completion Date

April 2012

Primary Completion Date

October 2011

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

J Marc Pipas, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01015300

Organization ID

D0904


Responsible Party

Sponsor

Study Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

 Genentech, Inc.

Study Sponsor

J Marc Pipas, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center


Verification Date

May 2012