Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

November 29, 2021 updated by: Dawnmarie DeFazio, West Penn Allegheny Health System

A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Penn Allegheny Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-5148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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