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


Phase 0
18 Years
N/A
Not Enrolling
Both
Hemangioblastomas, Von Hippel Lindau Disease

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

J Marc Pipas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Institutional Review Board

Study ID:

D0904

NCT ID:

NCT01015300

Start Date:

December 2009

Completion Date:

April 2012

Related Keywords:

  • Hemangioblastomas
  • Von Hippel Lindau Disease
  • Hemangioblastoma
  • Von Hippel Lindau
  • VHL
  • lesion
  • EGFR
  • Von Hippel-Lindau Disease
  • Hemangioblastoma

Name

Location

Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756