Doxycycline Injection of Cutaneous Schwannoma in Neurofibromatosis Type 2

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

In this research study the investigators want to learn more about an alternate, local treatment for skin schwannomas. Specifically, local doxycycline intra-tumoral injection will be performed as a potential treatment for NF2-related skin schwannomas, ultimately reducing the risks and costs associated with standard surgical removal of such skin tumors if successful.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:

• 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.

• 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

• Age ≥ 8 years on day 1 of treatment.

• Life expectancy of greater than 1 year

• Lansky/Karnofsky performance status ≥ 60

• Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy

• Any neurologic deficits must be stable for ≥1 week

• Patient or parent/legal guardian must be able to provide signed informed consent and assent (as applicable for minors)

Locations
United States
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Contact Information
Primary
Christopher Wood
cgwood@meei.harvard.edu
6175733632
Backup
D. Bradley Welling, MD, PhD
brad_welling@meei.harvard.edu
617-573-4075
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 19
Treatments
Experimental: Single Arm Open Label
Open Label
Sponsors
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov