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Could a common antibiotic shrink NF2 skin tumors without surgery?

NCT ID NCT05521048

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injecting doxycycline directly into skin schwannomas can shrink them in people with neurofibromatosis type 2 (NF2). Nineteen participants will receive up to three injections per tumor, with the dose based on tumor size. The goal is to find a less invasive alternative to surgery for these painful growths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
doxycycline
What this could lead to
If it works, this could offer a non-surgical option to shrink painful skin tumors in people with NF2, reducing the need for surgery.
What could go wrong
This is a small early-phase trial with only 19 people, so results may not apply to everyone. The injections may not shrink tumors or could cause side effects like pain or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 19 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene. The NIH criteria include presence of: * Bilateral vestibular schwannomas, OR * First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR * Two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity. The Manchester criteria include presence of: * Bilateral vestibular schwannomas, OR First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR - Two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity OR * Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR * Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR * Any two of: schwannoma, glioma, neurofibroma, cataract. 2. Patients must have measurable disease, defined as at least one cutaneous/subcutaneous schwannoma with the following qualities: * Maximal tumor diameter \> 0.5 cm to \< 4.0 cm that can be accurately measured by electronic calipers * Up to a maximum of 3 tumors/subject may be injected * Not located on the face 3. Age ≥ 8 years on day 1 of treatment. 4. Life expectancy of greater than 1 year 5. Lansky/Karnofsky performance status ≥ 60 6. Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy 7. Any neurologic deficits must be stable for ≥1 week 8. Patient or parent/legal guardian must be able to provide signed informed consent and assent (as applicable for minors) Exclusion Criteria: 1. Allergy to doxycycline or tetracycline 2. Tumors located on the face or major motor nerves 3. Patients currently receiving medical anticancer therapies or who have received medical anticancer therapies within 4 weeks of the start of study drug (including chemotherapy and molecular targeted agents), as these may interfere with the study drug 4. Radiation therapy to a study target tumor within 1 year prior to enrollment, or any radiation therapy within 4 weeks prior to enrollment, as these may interfere with our ability to assess response to study drug 5. Prior treatment with any investigational drug within the preceding 4 weeks, as they may interfere with the study drug 6. Unstable or rapidly progressive disease, including patients who require glucocorticoids for symptomatic control of brain or spinal tumors, as this would represent a high risk for inability to comply with the study requirements 7. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: * symptomatic congestive heart failure of New York heart Association Class III or IV * unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease * severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 90% or less at rest on room air * active (acute or chronic) or uncontrolled severe infections liver disease, such as cirrhosis or severe hepatic impairment (Child-Pugh class C) 8. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception (oral contraceptives, contraceptive implants, vaginal ring, or intrauterine devices (IUDs)) must be used at the time of injection but does not need to be carried out past the 1st month of observation. 9. History of significant noncompliance with follow-up that would jeopardize the study evaluation. 10. Patients unwilling to or unable to comply with the study protocol.

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Conditions

The condition(s) this trial relates to.

Neurofibromatosis 2 NF2-related schwannomatosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02214, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.