The clinical trial for the medication sirolimus is now closed for patients with idiopathic/HHV-8-negative multicentric Castleman disease (iMCD)
The trial was open for patients with idiopathic (HHV-8-negative) multicentric Castleman disease who continued to experience significant symptoms after trying either siltuximab or tocilizumab.
About the clinical trial
Dr. David Fajgenbaum, Principal Investigator, University of Pennsylvania
The Castleman Disease Collaborative Network (CDCN) partnered with the University of Pennsylvania and the University of Arkansas for Medical Sciences to conduct a research study of an investigational medicine, sirolimus, for adults who have idiopathic multicentric Castleman disease (iMCD) and are unable to benefit from anti-IL-6 therapies. Anti-IL-6 therapies are siltuximab (Sylvant) and tocilizumab (Actemra). This trial is now closed to enrollment. Please visit this page in the future for upcoming trial information.
Enrollment Criteria
Patients who were included in this clinical trial met the following criteria:
- Officially diagnosed with idiopathic (HHV-8-negative) multicentric Castleman disease by a physician
- are between the ages of 18 and 80
- have previously taken either siltuximab (Sylvant) or tocilizumab (Actemra) and did not have significant disease improvement while taking these medications OR were not able to stay on these medications due to severe side effects or allergic reaction
- have active disease with signs and symptoms of Castleman disease at the time of enrollment in the trial
About sirolimus
Dr. Frits van Rhee, Principal Investigator, University of Arkansas
Sirolimus is a medication that blocks a cell signaling pathway called m-TOR. This drug was originally created to prevent organ rejection in people who had received kidney transplants, and sirolimus became FDA-approved for this use in 1999. Sirolimus is taken orally as a pill and is not an IV medication.
While siltuximab is the only FDA-approved drug for Castleman disease, the first study showing that sirolimus may benefit patients with Castleman disease was published in August 2019. The study included three patients with idiopathic mulitcentric Castleman disease (iMCD) in whom siltuximab had not worked, and the result showed that taking sirolimus had put each of these patients into remission. Read the full text of this published paper here.
If you are interested in sirolimus, contact your physician about your options. If you are thinking about changing your medication, please let our research team know by emailing castlebank@uphs.upenn.edu or calling 267-586-9977.
I still have questions. Where can I find answers?
Research staff are available to answer all questions and provide additional information.
- Phone: Tracey Sikora, (215) 614-0199
- Email: CDTrial@PennMedicine.UPenn.edu