Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01207687
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2010-09-01
Brief Title:
Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 NF2
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Study of Bevacizumab in Children and Adults With Neurofibromatosis Type 2 and Symptomatic Vestibular Schwannoma
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People who have neurofibromatosis type 2 NF2 can have tumors that grow on the auditory nerves and cause hearing loss These tumors are called vestibular schwannomas VSs or acoustic neuromas People with NF2 can also get schwannomas in other parts of their body as well as tumors called meningiomas and ependymomas Because VSs can cause hearing loss many people with NF2 will have treatment to preserve their hearing This treatment usually involves surgery Because surgery has risks and is not able to help everyone with VSs other methods of treatment are being explored One area of exploration is looking to see if there is a drug that can be taken that might prevent the VSs from growing larger and causing hearing loss or brainstem compression This study is exploring whether a drug that is approved by the FDA and is currently used to treat other tumors might also work to treat VSs Based on people who have taken this drug to treat VSs already there is some reason to think that it might be helpful to certain people with NF2 People enrolled in this study will receive the drug one time every three weeks for one year by infusion This study will follow subjects over the course of the year that the person is taking the drug and for six months after the drug is stopped This study is recruiting people who have NF2 and are currently having symptoms of tinnitus dizziness andor hearing loss from their VSs If you have NF2 and are currently having symptoms caused by your VSs you may be eligible to participate
Detailed Description:
PRIMARY OBJECTIVES
I The primary objective of this study is to determine the activity of bevacizumab for treatment of symptomatic vestibular schwannomas VS defined as progressive hearing loss in patients with neurofibromatosis type 2 NF2 based on objective hearing response
SECONDARY OJBECTIVES
I Determine the safety and tolerability of bevacizumab in this patient population on an every three week dosing schedule of 75mgkg for 12 months of therapy
II Assess the rate of radiographic response 20 reduction in volume III Determine the growth rate of VS using volumetric MRI analysis in comparison to 1-dimensional and 2-dimensional measurements
IV Assess changes in function of the auditory system during bevacizumab treatment
V Assess the vascular permeability Ktrans relative cerebral blood volumeflow mean transit time and mean vessel diameter from perfusion-weighted MRI
VI Assess the change in circulating endothelial cells circulating progenitor cells and plasma angiogenic proteins in subjects receiving bevacizumab treatment
VII Observe the impact of bevacizumab on non-VS tumors in patients with NF2 via whole body MRI
VIII Explore hearing related QOL measures throughout treatment IX Explore the effect of treatment with bevacizumab on auditory function using distortion product optoacoustic emissions DPOAE to be evaluated at NCI only
OUTLINE
Patients receive bevacizumab intravenously IV over 30-90 minutes once every 3 weeks Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 and 6 months
I The primary objective of this study is to determine the activity of bevacizumab for treatment of symptomatic vestibular schwannomas VS defined as progressive hearing loss in patients with neurofibromatosis type 2 NF2 based on objective hearing response
SECONDARY OJBECTIVES
I Determine the safety and tolerability of bevacizumab in this patient population on an every three week dosing schedule of 75mgkg for 12 months of therapy
II Assess the rate of radiographic response 20 reduction in volume III Determine the growth rate of VS using volumetric MRI analysis in comparison to 1-dimensional and 2-dimensional measurements
IV Assess changes in function of the auditory system during bevacizumab treatment
V Assess the vascular permeability Ktrans relative cerebral blood volumeflow mean transit time and mean vessel diameter from perfusion-weighted MRI
VI Assess the change in circulating endothelial cells circulating progenitor cells and plasma angiogenic proteins in subjects receiving bevacizumab treatment
VII Observe the impact of bevacizumab on non-VS tumors in patients with NF2 via whole body MRI
VIII Explore hearing related QOL measures throughout treatment IX Explore the effect of treatment with bevacizumab on auditory function using distortion product optoacoustic emissions DPOAE to be evaluated at NCI only
OUTLINE
Patients receive bevacizumab intravenously IV over 30-90 minutes once every 3 weeks Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA006973 | NIH | CTEP | httpsreporternihgovquickSearchP30CA006973 |
| NCI-2012-02987 | REGISTRY | None | None |
| J1002 | None | None | None |
| NA_00034732 | OTHER | None | None |
| 8248 | OTHER | None | None |