Actively Recruiting
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
Led by Massachusetts General Hospital · Updated on 2026-04-23
40
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: * Investigational Drug Sub-Study A: Siltuximab * Investigation Drug Sub-Study B: Erenumab-Aooe
CONDITIONS
Official Title
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of schwannomatosis by clinical or molecular criteria
- Age 18 years or older at Day 1 of treatment
- Karnofsky performance status of 70 or higher or ECOG performance status 0 or 1
- Moderate to severe pain due to schwannomatosis with maximum pain score of 5 or higher on Numeric Rating Scale-11 in the past 7 days
- Ability and willingness to provide written informed consent and assent
- Established relationship with a primary care physician and able to provide contact information
- For Sub-study A (Siltuximab): willing to consent, moderate to severe pain with median NRS-11 score 5 or higher at screening, insufficient response or intolerance to standard pain therapies, and meeting specified laboratory value requirements
- For Sub-study B (Erenumab-Aooe): willing to consent, moderate to severe pain with median NRS-11 score 5 or higher at screening, insufficient response or intolerance to standard pain therapies, and meeting specified laboratory value requirements
- Female participants of childbearing potential must agree to use two highly effective contraception methods during the study and for a defined period after last dose
- Female participants of non-childbearing potential must meet criteria such as hysterectomy, ovarian failure, or postmenopausal status
You will not qualify if you...
- Chemotherapy within 4 weeks prior to study registration or unresolved toxicities
- Currently receiving other investigational agents
- Nervous system tumors likely to require active treatment within 6 months
- History of malignancy within last 3 years unless disease-free for 2 years or low risk of progression
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
- Allergic or anaphylactic reaction history to monoclonal antibodies or IgG fusion proteins
- Pain due to causes other than schwannomatosis such as cancer therapy or bone fractures
- Increased risk for gastrointestinal perforation or chronic use of high-dose glucocorticoids
- Serious medical or psychiatric illness interfering with treatment completion
- Recent major surgery within 30 days (minor procedures allowed)
- Uncontrolled or active cardiovascular disease including recent myocardial infarction, unstable angina, heart failure, arrhythmias, or stroke
- Uncontrolled hypertension despite treatment
- Active or ongoing significant infections requiring IV antibiotics
- Known HIV infection
- Conditions compromising safety or evaluation of study drugs
- Lactating women excluded from Sub-study B
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Scott Plotkin, MD, PhD
CONTACT
L
Lei Xu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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