Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
|ClinicalTrials.gov Identifier: NCT01331616|
Recruitment Status : Unknown
Verified April 2011 by West Penn Allegheny Health System.
Recruitment status was: Recruiting
First Posted : April 8, 2011
Last Update Posted : April 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Optic Neuropathy||Drug: Bevacizumab (Avastin)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||July 2012|
|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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331616
|Contact: Robert Alan Fishman, MDfirstname.lastname@example.org|
|Contact: Lara Kunschner, MD||412-259-8850|
|United States, Pennsylvania|
|Allegheny General Neurology Department/Neuro-Oncology||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15212|
|Contact: Robert A Fishman, MD 412-204-6104 email@example.com|
|Contact: Lara Kunschner, MD 412-359-8850|
|Principal Investigator: Robert Fishman, MD|