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Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

Primary Purpose

Glioblastoma, Optic Neuropathy

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Bevacizumab (Avastin)
Sponsored by
West Penn Allegheny Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Prospective study, Glioblastoma, Avastin, Visual Evoked Potential, Optic neuropathy, Chemo-radiotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bevacizumab (Avastin)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients.
    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
    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.

    Full Information

    First Posted
    April 1, 2011
    Last Updated
    November 29, 2021
    Sponsor
    West Penn Allegheny Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01331616
    Brief Title
    Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
    Official Title
    A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West Penn Allegheny Health System

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma, Optic Neuropathy
    Keywords
    Prospective study, Glioblastoma, Avastin, Visual Evoked Potential, Optic neuropathy, Chemo-radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bevacizumab (Avastin)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab (Avastin)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients.
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment
    Description
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

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