Concentration and Activity of Lapatinib in Vestibular Schwannomas

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00863122
Phase
EARLY_PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib — DRUG
    1500 mg lapatinib by mouth per day for 10 days

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Dec 2020
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: lapatinib
    Subjects will receive lapatinib for 10 days prior to surgery for vestibular schwannoma resection.
  • No Intervention: control
    Control subjects will not receive any intervention prior to surgery for vestibular schwannoma resection.

Primary Outcome Measure

Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection [ Time Frame: At time of surgery, 10-13 days from starting drug. ]

Locations (7)

FacilityCityStateZIPSite coordinators
House Reserach InstituteLos AngelesCalifornia90057-
Johns Hopkins HospitalBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University Medical CenterSt LouisMissouri63110-
New York University Medical CenterNew YorkNew York10016-
Weil Cornell Medical College, New York Presbyterian HospitalNew YorkNew York10065-
Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Los Angeles, CA

By research site
House Reserach Institute· Los Angeles, CAJohns Hopkins Hospital· Baltimore, MDMassachusetts General Hospital· Boston, MAWashington University Medical Center· St Louis, MONew York University Medical Center· New York, NYWeil Cornell Medical College, New York Presbyterian Hospital· New York, NY

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