Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by West Penn Allegheny Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01331616
First received: April 1, 2011
Last updated: April 21, 2011
Last verified: April 2011

April 1, 2011
April 21, 2011
March 2011
March 2012   (final data collection date for primary outcome measure)
Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Measurement of Visual Evokd Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01331616 on ClinicalTrials.gov Archive Site
Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
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?

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.

Interventional
Phase 0
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glioblastoma
  • Optic Neuropathy
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.
Experimental: Bevacizumab (Avastin)
Intervention: Drug: Bevacizumab (Avastin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Robert Alan Fishman, MD 412-294-6104 rfishman@wpahs.org
Contact: Lara Kunschner, MD 412-259-8850
United States
 
NCT01331616
RC-5148
Yes
Dr. Lara Kunschner, Allegheny General Neuro-Oncology Department
West Penn Allegheny Health System
Not Provided
Not Provided
West Penn Allegheny Health System
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP