CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 26 enrolled
Drug / intervention
lapatinibdrug
Likely dose
lapatinib 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00863122
NCT00863122Early Ph 1Completed

Exploration and Estimation of Intratumoral Concentration and Activity of Lapatinib in Vivo in Vestibular Schwannomas

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Mar 17, 2009·Updated Jan 12, 2021

In Brief

A Early Phase 1 clinical trial evaluating lapatinib for Vestibular Schwannoma and 4 related conditions. Completed, enrolled 26 participants across 7 sites.

Detailed 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.

Study Details

Timeline

Early Ph 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2014
TodayJul 3, 2026
Enrollment to primary: 5.2 yearsPosted 17.3 years ago

Interventions

lapatinibdrug

1500 mg lapatinib by mouth per day for 10 days