Concentration and Activity of Lapatinib in Vestibular Schwannomas

Summary

Tumors can grow on the auditory nerves and can cause hearing loss. A common type of tumor that does this is a vestibular schwannoma (VS), or acoustic neuroma. These tumors are not cancerous. Most often, people have only one VS. Occasionally, people have more than one VS and may have a condition called neurofibromatosis type 2 (NF2).

Because VS can cause hearing loss, many people with VS will have treatment to preserve their hearing. This treatment usually involves surgery or radiation therapy. There are risks to these procedures, and sometimes they do not work to prevent hearing loss. Because surgery and radiation have risks and are not able to help everyone with VS, 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 VS from growing larger and causing hearing loss, and might possibly even cause the VS to shrink in size.

This study is exploring whether a drug that is approved by the FDA and is currently used to treat breast cancer might also work to treat VS. This study will measure the amount of drug that travels from the bloodstream and arrives at the tumor. This drug is safe and has few side effects. If this drug is shown to reach the tumor, it might be used in the future to treat VS without needing surgery or radiation.

This study is recruiting people who are having surgery for VS. If you are going to have surgery to treat a VS, you may be eligible to participate.

Conditions

• Vestibular Schwannoma
• NF2
• Neurofibromatosis 2
• Acoustic Neuroma
• Auditory Tumor

Interventions

DRUG

lapatinib

1500 mg lapatinib by mouth per day for 10 days

Sponsors & Collaborators

• The Children's Tumor Foundation

  collaborator OTHER

• GlaxoSmithKline

  collaborator INDUSTRY

• New York University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• House Research Institute

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Jaishri O Blakeley, MD · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• United States

Study Locations