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Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

NCT ID: NCT01331616

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glioblastoma Optic Neuropathy

Keywords

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Prospective study Glioblastoma Avastin Visual Evoked Potential Optic neuropathy Chemo-radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab (Avastin)

Group Type EXPERIMENTAL

Bevacizumab (Avastin)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Penn Allegheny Health System

OTHER

Sponsor Role lead

Responsible Party

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Dawnmarie DeFazio

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Countries

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United States

Other Identifiers

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RC-5148

Identifier Type: -

Identifier Source: org_study_id