TerminatedPhase 2

Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors

Stopped: Results review of patient data

United States10 participantsStarted 2017-05-08

Plain-language summary

In this research study the researchers want to learn more about the effects (both good and bad) the study drug selumetinib has on participants with neurofibromatosis type II (NF2) related tumor. The researchers are asking patients with NF2 related tumors to be in the study, because their hearing has decreased and/or their NF2 related tumor has started to grow. The goals of this study are: * Determine if selumetinib will stop NF2 related tumors from growing * Measure the changes in hearing after receiving selumetinib for 6 months. * Determine if selumetinib improves how participants feel (physically and emotionally) and how participants can perform daily activities. * Examine tumor tissue, if available, in a laboratory to see if NF2 related tumors have targets of selumetinib.

Who can participate

Age range

3 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy (CSR) or retinal vein occlusion
. Intraocular pressure (IOP) \> 21 mmHg or uncontrolled glaucoma (irrespective of IOP)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stratum 1- Number of Patients With Hearing Response at 24 Weeks as Measured by Word Recognition

Timeframe: 24 weeks

Radiographic Tumor Response

Timeframe: Through study completion up to 2 years

Trial details

NCT IDNCT03095248

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-21

Results submitted2025-01-15

View on ClinicalTrials.gov More Neurofibromatosis 2 trials