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

Von Hippel Lindau Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01015300
• Other study ID #: D0904
• Status: Terminated
• Phase: Phase 0
• First received: November 16, 2009
• Last updated: May 9, 2012
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemangioblastoma
• Hemangioblastomas
• Von Hippel Lindau Disease
• Von Hippel-Lindau Disease

Intervention

Drug:
• Avastin
Patients will receive Bevacizumab (Avastin) 10mg/kg IV every two weeks for 6 months

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic response in the size of the hemangioblastoma on magnetic resonance imaging (MRI)		24 months	Yes
Secondary	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.		24 months	Yes