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Anti-bacterial

Doxycycline Injection for Neurofibromatosis Type 2

Phase 1 & 2
Recruiting
Led By D. Bradley Welling, MD, PhD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 8 years on day 1 of treatment.
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.
Must not have
Tumors located on the face or major motor nerves
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months, 1-year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new, less invasive treatment for skin tumors caused by NF2. If successful, it could reduce the risks and costs of standard surgery.

Who is the study for?
This trial is for individuals aged 8 or older with neurofibromatosis type 2 (NF2) and skin schwannomas. Participants must have stable neurological conditions, a life expectancy over a year, and be able to give consent. They should not be on recent anticancer treatments or have severe medical issues that could affect participation.
What is being tested?
The study tests local injections of Doxycycline directly into the skin tumors of NF2 patients as an alternative to surgery. The goal is to see if this method can effectively reduce tumor size while being less risky and costly than standard surgical procedures.
What are the potential side effects?
Potential side effects may include typical reactions to doxycycline such as allergic responses, gastrointestinal upset, photosensitivity, headaches, dizziness, or local site reactions like pain and swelling at the injection area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 8 years old or older.
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I have been diagnosed with neurofibromatosis 2.
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I can care for myself but may need occasional help.
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I have a visible schwannoma that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor is on my face or affects major nerves for movement.
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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.
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My cancer is quickly worsening and I need steroids for brain or spine tumor symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months, 1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months, 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor Maximal Diameter

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm Open LabelExperimental Treatment1 Intervention
Open Label

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
109 Previous Clinical Trials
13,135 Total Patients Enrolled
D. Bradley Welling, MD, PhDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Doxycycline Injection (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT05521048 — Phase 1 & 2
Acoustic neuroma Research Study Groups: Single Arm Open Label
Acoustic neuroma Clinical Trial 2023: Doxycycline Injection Highlights & Side Effects. Trial Name: NCT05521048 — Phase 1 & 2
Doxycycline Injection (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521048 — Phase 1 & 2
~6 spots leftby Nov 2025
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