RECRUITING

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Quick Facts

Study Start:2023-08-31
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05684692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Scott Plotkin, MD, PhD
CONTACT
617-643-8992
lmhibyan@partners.org
Lei Xu, PhD
CONTACT
617-726-8051
lei@steele.mgh.harvard.edu

Principal Investigator

Scott Plotkin, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Scott Plotkin, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-31
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

  • Schwannomatosis
  • Schwannomas
  • Pain
  • chronic Pain
  • Severe Pain

Additional Relevant MeSH Terms

  • Schwannomatosis
  • Schwannomas
  • Pain, Chronic