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Withdrawn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
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
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
NCT ID
NCT01331616
First Posted
April 1, 2011
Last Updated
November 29, 2021
Sponsor
West Penn Allegheny Health System
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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