Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Case Comprehensive Cancer Center
Summary
The goal of this prospective phase 2 study is to assess the efficacy and safety of intestinal or multivisceral transplantation for participants with PMP not amenable to other curative-intent treatments. Participants will undergo intestinal/multivisceral transplantation. Participants will be followed for 12 months to assess efficacy and safety.
Description
Pseudomyxoma peritonei (PMP) is a rare clinical entity (approximately 2-4 cases per million people) characterized by extensive dissemination of mucinous ascites in the abdominal cavity. Relentless accumulation of mucin causes progressive abdominal distention, intestinal obstruction, malnutrition, cachexia, and ultimately death. As a rare disease, diagnosis is often late, and usually occurs when the disease is in a clinically advanced stage. The prognosis of PMP has been dramatically improved by the introduction of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must have histologically confirmed pseudomyxoma peritonei (PMP) * Both low-grade mucinous carcinoma peritonei (LMCP) or high-grade mucinous carcinoma (HMCP), with or without signet ring cells as well as primary or recurrent disease, will be eligible. * PMP disease does not have any extra-abdominal metastases, with the exception of pulmonary involvement (nodal, parenchymal, and pleural). * PMP disease is extensive and not amenable to operative management, with or without liver, pancreas, stomach, or abdominal wall involvement. * Definition of Non-Resectable…
Interventions
- ProcedureIntestinal, Multivisceral or Modified Multivisceral Transplantation
Enrolled participants will enter the active transplant waiting list within one month of signing informed consent for study participation. Participants can be listed for: * Isolated small bowel transplant (SBT): transplantation of the donor small intestine * Modified multivisceral tran I lant (MMVT): transplantation of the donor pancreas and small intestine, with or without stomach * Multivisceral transplant (MVT): transplantation of the donor pancreas, small intestine, and liver, with or without stomach
- DrugAlemtuzumab
A post-transplant, steroid-free immunosuppressive regimen will be utilized and will include Alemtuzumab as Antibody Induction Therapy. Participants will be administered two doses of Alemtuzumab (30 mg IV) on days 0 and 1.
- DrugTacrolimus
A post-transplant, steroid-free immunosuppressive regimen will be utilized and will include Tacrolimus for maintenance. Participants will have Tacrolimus for the first 3 months. Dosing of Tacrolimus will depend on participant target level, starting with 0.05 mg/Kg bid.
- DrugSirolimus
A post-transplant, steroid-free immunosuppressive regimen will be utilized and will include Sirolimus for maintenance. Participants will have Sirolimus after 3 months of Tacrolimus. Dosing of Sirolimus will depend on participant target level, starting with 2 mg od.
Location
- Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer CenterCleveland, Ohio