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NCT01207687 · ClinicalTrials.gov registry record · Phase 2

Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)

A Phase 2 study of Vestibular Schwannoma and Neurofibromatosis Type 2, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
3
Study locations

NCT01207687 is a Phase 2 study of Vestibular Schwannoma and Neurofibromatosis Type 2 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 50-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (72% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT01207687, a Phase 2 study of Vestibular Schwannoma and Neurofibromatosis Type 2, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
3
Study locations

Study 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, and/or hearing loss from their VSs. If you have NF2 and are currently having symptoms caused by your VSs, you may be eligible to participate.

Interventions

  • OTHER laboratory biomarker analysis
  • PROCEDURE quality-of-life assessment
  • BIOLOGICAL bevacizumab

Study Locations (3)

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
  • National Cancer Institute - Rockville

Massachusetts

  • Massachusetts General Hospital - Charlestown

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2010-10
Est. Completion 2014-03
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01207687

The ClinicalTrials.gov registry entry for NCT01207687 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 50-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (72% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Vestibular Schwannoma appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01207687 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01207687 about?

NCT01207687 is a clinical study titled "Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)". 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 meningio...

What is the current status of trial NCT01207687?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2010-10. Estimated completion is 2014-03.

What conditions does trial NCT01207687 study?

This clinical trial studies the following conditions: Vestibular Schwannoma, Neurofibromatosis Type 2.

What interventions are being tested in trial NCT01207687?

The interventions under investigation include: laboratory biomarker analysis (OTHER), quality-of-life assessment (PROCEDURE), bevacizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01207687?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01207687 being conducted?

This trial has 3 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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