Doxycycline in Cutaneous Schwannoma (NF2) (NCT05521048) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Doxycycline in Cutaneous Schwannoma (NF2)
United States19 participantsStarted 2022-09-19
Plain-language 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.
Who can participate
Age range8 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Patients must have measurable disease, defined as at least one cutaneous/subcutaneous schwannoma with the following qualities:
✓. 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)
Exclusion criteria
✕. Allergy to doxycycline or tetracycline
✕. Tumors located on the face or major motor nerves
✕. 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
✕. 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
✕. Prior treatment with any investigational drug within the preceding 4 weeks, as they may interfere with the study drug
✕. 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
✕. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
✕. 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.