Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by West Penn Allegheny Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01331616
First received: April 1, 2011
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?


Condition Intervention Phase
Glioblastoma
Optic Neuropathy
Drug: Bevacizumab (Avastin)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331616

Contacts
Contact: Robert Alan Fishman, MD 412-294-6104 rfishman@wpahs.org
Contact: Lara Kunschner, MD 412-259-8850

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

No publications provided

Responsible Party: Dr. Lara Kunschner, Allegheny General Neuro-Oncology Department
ClinicalTrials.gov Identifier: NCT01331616     History of Changes
Other Study ID Numbers: RC-5148
Study First Received: April 1, 2011
Last Updated: April 21, 2011
Health Authority: United States: Alleghney General Hospital
United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Prospective study
Glioblastoma
Avastin
Visual Evoked Potential
Optic neuropathy
Chemo-radiotherapy

Additional relevant MeSH terms:
Glioblastoma
Peripheral Nervous System Diseases
Optic Nerve Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
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 October 01, 2014