This phase II trial investigates whether intestinal or multivisceral transplantation can improve survival in patients with mucinous carcinoma peritonei (also known as pseudomyxoma peritonei) that cannot be removed by surgery (unresectable) and who do not have any other available curative options. Pseudomyxoma peritonei is a rare disease characterized by extensive mucous secreting cells scattered within the abdominal cavity. Accumulation of mucous over time causes abdominal distention, intestinal blockage, malnutrition, loss of body weight and muscle mass, and ultimately death. As a rare disease, diagnosis is often late and usually occurs when the disease is in a clinically advanced stage. Patients with unresectable pseudomyxoma peritonei have no curative treatment options, however, research shows that intestinal transplant may prolong the survival and increase quality of life for patients. Undergoing intestinal or multivisceral transplantation may be safe and/or effective in treating patients with unresectable pseudomyxoma peritonei.
Additional locations may be listed on ClinicalTrials.gov for NCT06084780.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Approved
Contact: Masato Fujiki
Phone: 216-444-8007
PRIMARY OBJECTIVE:
I. To determine overall 12-month survival after intestinal or multivisceral transplantation in patients with unresectable pseudomyxoma peritonei (PMP).
SECONDARY OBJECTIVES:
I. To determine the morbidity of intestinal or multivisceral transplantation for patients with unresectable PMP at 90 days and 12 months by monitoring severe adverse events as classified according to Clavien-Dindo grade and comprehensive complication index.
II. To determine cancer-related and transplant-related mortality after intestinal or multivisceral transplantation in patients with unresectable PMP within 12 months of transplant.
CORRELATIVE OBJECTIVE:
I. To determine the relationship between tumor burden, defined by the peritoneal cancer index (PCI), and overall survival at 12 months after transplant.
OUTLINE:
Patients undergo intestinal or multivisceral transplant on study (day 0). Within 3 hours after transplant surgery, patients receive alemtuzumab intravenously (IV) over 2 hours once daily (QD) on days 0 and 1. Patients then receive tacrolimus IV twice daily (BID) for 3 months followed by sirolimus IV QD for an additional 3 months. Patients also undergo urine sample collection, ultrasound, and angiography during screening, chest x-rays during screening and on study, and computed tomography (CT) and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months post-transplant.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorMasato Fujiki
