Doxycycline in Cutaneous Schwannoma (NF2)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Study Design: Interventional Clinical Trial, single-arm, open-label Estimated Enrollment: Up to 19 participants with NF2-associated cutaneous or subcutaneous schwannomas Aims: To demonstrate change in peripheral schwannoma size following direct injection into the tumor with doxycycline hyclate. Nineteen neurofibromatosis type 2-associated peripheral cutaneous or subcutaneous schwannomas between 0.5 cm and 4 cm in greatest diameter will be diagnosed clinically, photographed for documentation of location, and injected with between 0.1 ml to 4 ml of 10mg/ml doxycycline hyclate (Fresenius Kabi, Canton, MA). A maximum of three tumors per patient will be injected. The dose administered will be calculated based on tumor size, not to exceed the estimated volume of the tumor or a maximum of 4 ml. The tumor volume will be estimated by electronic caliper measure of the greatest tumor diameter (D). (V=4/3piR3 where R is the radius (R=D/2) is measured in millimeters and the dose calculated by Vmm3/1000 = injection volume in milliliters). Repeat measures will be made at 6-months and 1-year follow up (+/- 1 month) and documented with electronic calipers and photography. Injection of 1% lidocaine may be given pre-doxycycline to reduce injection pain. Outcome: The primary outcome will be longitudinal change in tumor maximal diameter measured at 6-months and 1-year compared to baseline defined by a change of 25%. Secondary endpoints include patient reports of paresthesia, pain, skin breakdown or discoloration. Exploratory endpoints will be the change in the sum of maximal diameters. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05521048
Study type	Interventional
Source	Massachusetts Eye and Ear Infirmary
Contact	Christopher Wood
Phone	6175733632
Email	cgwood@meei.harvard.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	September 19, 2022
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT01552434` - Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease	Phase 1
Completed	`NCT01880749` - Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas	Early Phase 1
Recruiting	`NCT05130866` - Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas	Phase 2/Phase 3
Recruiting	`NCT04374305` - Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)	Phase 2
Completed	`NCT01125046` - Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas	Phase 2
Completed	`NCT03210285` - WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Completed	`NCT02934256` - Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	Phase 2
Terminated	`NCT01345136` - Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma	Phase 2
Completed	`NCT02104323` - Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	Phase 2
Completed	`NCT02246231` - Effect of Implant Position on Magnetic Resonance Image Distortion	N/A
Terminated	`NCT02282917` - Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma	Early Phase 1
Completed	`NCT02129647` - Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas	Phase 2
No longer available	`NCT02589912` - Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.