Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Eligibility criteria
Qualifiers
Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis.
Two or more non-intradermal schwannomas, one with pathological confirmation, without evidence of bilateral vestibular schwannoma (see
Disqualifiers
one pathologically confirmed schwannoma or intracranial meningioma and
An affected first-degree relative. Molecular diagnosis
A molecular diagnosis of schwannomatosis is confirmed by either (1) two or more pathologically proven schwannomas or meningiomas AND genetic studies of at least two tumors with loss of heterozygosity (LOH) for chromosome 22 and two different NF2 mutations; or (2) one pathologically proven schwannoma or meningioma and a germline SMARCB1 or LZTR1 pathogenic mutation.
Participant must be ≥ 18 years of age on Day 1 of treatment.
Trial design
Treatments tested in this trial
- Siltuximab
- Erenumab-Aooe
- Siltuximab Matching Placebo
- Erenumab-Aooe Matching Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
United States Department of Defense
Collaborator
RECORDATI GROUP
Collaborator
Source ClinicalTrials.gov