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Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by West Penn Allegheny Health System.
Recruitment status was:  Recruiting
Information provided by:
West Penn Allegheny Health System Identifier:
First received: April 1, 2011
Last updated: April 21, 2011
Last verified: April 2011
Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?

Condition Intervention Phase
Optic Neuropathy
Drug: Bevacizumab (Avastin)
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

Resource links provided by NLM:

Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients. [ Time Frame: 1 year ]
    Does Avastin lead to optic neuropathy in combination w chemo-radiotherapy? Our research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. In our study of VEP, we will be measuring optic nerve function, to asses if there has been any damage.

Secondary Outcome Measures:
  • Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment [ Time Frame: 1 year ]
    The investigators will compare the results of the patient's Visual Evoked Potential (VEP) testing performed prior to treatment with Avastin and chemo-radiotherapy to the results of the VEP after completion to assess optic nerve function; and any signs of direct optic neuropathy In our study the investigators will compare the results of the Visual Evoked Potential results performed prior to the chemoradiation to results of the Visual Evoked Potential after completion of standard-of-care treatment for glioblastoma.

Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab (Avastin) Drug: Bevacizumab (Avastin)
Dosage is: 10 mg/kg every 2 weeks as monotherapy or in combination (unlabeled) with irinotecan. Patients will also receive Radiotherapy prior to beginning chemotherapy.

Detailed Description:
The investigators research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing a baseline visual examination with Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. Patients will then begin their normally scheduled treatment with avastin, and other chemotherapeutic agents, as well any radiation treatments scheduled. Once patients have completed their treatment with avastin for 6-8 weeks, they will then undergo their second Visual Evoked Potential testing, with both studies then being compared for any changes within the optic nerves. Patients will also be recommended to have stringent follow up with an Ophthalmologist to include confrontational visual field testing, external and anterior segment examination, and dilated fundus examination. The investigators main objective is to assess whether or not bevacizumab causes a direct toxic effect on patient's optic nerves leading to an acute/subacute optic neuropathy.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin

Exclusion Criteria:

  • No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01331616

Contact: Robert Alan Fishman, MD 412-294-6104
Contact: Lara Kunschner, MD 412-259-8850

United States, Pennsylvania
Allegheny General Neurology Department/Neuro-Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Robert A Fishman, MD    412-204-6104   
Contact: Lara Kunschner, MD    412-359-8850      
Principal Investigator: Robert Fishman, MD         
Sponsors and Collaborators
West Penn Allegheny Health System
  More Information

Responsible Party: Dr. Lara Kunschner, Allegheny General Neuro-Oncology Department Identifier: NCT01331616     History of Changes
Other Study ID Numbers: RC-5148
Study First Received: April 1, 2011
Last Updated: April 21, 2011

Keywords provided by West Penn Allegheny Health System:
Prospective study
Visual Evoked Potential
Optic neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Optic Nerve Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on April 28, 2017