GlioblastomaEarly Phase 1NCT01331616
Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
A Early Phase 1 study testing Bevacizumab (Avastin) in people with Glioblastoma and Optic Neuropathy, run by West Penn Allegheny Health System.
Trial summary
Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma, Optic Neuropathy
- What is being tested?
- Bevacizumab (Avastin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jul 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin
Who cannot join
- No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.
About this study
Official title: 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?
Read the 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.
- Conditions
- Glioblastoma, Optic Neuropathy
- Being tested
- Bevacizumab (Avastin)
- Keywords
- Prospective study, Glioblastoma, Avastin, Visual Evoked Potential, Optic neuropathy, Chemo-radiotherapy
- Medical subject headings
- Glioblastoma, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin)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.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab (Avastin) | Experimental | Not described Receives: Drug: Bevacizumab (Avastin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawnmarie DeFazio, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331616
- Sponsor's protocol ID
- RC-5148
- Status last verified
- Nov 2021
- First submitted
- 1 Apr 2011
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
- ClinicalTrials.gov ID
- NCT01331616
- Acronym / sponsor ID
- RC-5148
- Conditions
- Glioblastoma, Optic Neuropathy
- Keywords
- Prospective study, Glioblastoma, Avastin, Visual Evoked Potential, Optic neuropathy, Chemo-radiotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab (Avastin) | Experimental | Drug: Bevacizumab (Avastin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin
Key exclusion criteria (1 listed)
- No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Bevacizumab (Avastin) |
Primary outcome
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.
1 secondary outcome
Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bevacizumab (Avastin) in people with Glioblastoma and Optic Neuropathy, run by West Penn Allegheny Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.