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NCT01331616 Clinical Trial

Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01331616
Other study ID # RC-5148
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date March 2011
Est. completion date July 2012

Study information
Verified date November 2021
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
West Penn Allegheny Health System

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary 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. 1 year
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