Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
Recruitment status was Recruiting
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Purpose
Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Optic Neuropathy |
Drug: Bevacizumab (Avastin) |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab |
- 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.
- 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.
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Robert Alan Fishman, MD | 412-294-6104 | rfishman@wpahs.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 rfishman@wpahs.org | |
| Contact: Lara Kunschner, MD 412-359-8850 | |
| Principal Investigator: Robert Fishman, MD | |
More Information
No publications provided
| Responsible Party: | Dr. Lara Kunschner, Allegheny General Neuro-Oncology Department |
| ClinicalTrials.gov Identifier: | NCT01331616 History of Changes |
| Other Study ID Numbers: | RC-5148 |
| Study First Received: | April 1, 2011 |
| Last Updated: | April 21, 2011 |
| Health Authority: | United States: Alleghney General Hospital United States: Institutional Review Board |
Keywords provided by West Penn Allegheny Health System:
|
Prospective study Glioblastoma Avastin |
Visual Evoked Potential Optic neuropathy Chemo-radiotherapy |
Additional relevant MeSH terms:
|
Optic Nerve Diseases Glioblastoma Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Cranial Nerve Diseases Nervous System Diseases Eye Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Poisoning Substance-Related Disorders Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013