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.
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.
Subjects with peritoneal carcinomatous originating from an etiology other than PMP.
Subjects receiving any other investigational agents.
Subjects with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would either put participation at risk because of participation in the study, may influence the result of the study, or limit compliance with study requirements.
Pregnant women are excluded from this study because an intestinal transplant is a procedure that is not compatible with a viable pregnancy.
Single group
Intestinal, Multivisceral or Modified Multivisceral Transplantation
Procedure/SurgeryEnrolled 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
Alemtuzumab
DrugA 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.
Tacrolimus
DrugA 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.
Sirolimus
DrugA 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.
Overall Rate of Survival
To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.
Overall Rate of Morbidity
Determine the morbidity of intestinal or multivisceral transplantation for participants with unresectable at 90 days by monitoring severe adverse events as classified according to Clavien-Dindo grade and comprehensive complication index.
Overall Rate of Morbidity
Determine the morbidity of intestinal or multivisceral transplantation for participants with unresectable at 12 months by monitoring severe adverse events as classified according to Clavien-Dindo grade and comprehensive complication index.
Overall Rate of Mortality
Determine cancer-related and transplant-related mortality after intestinal or multivisceral transplantation in participants with unresectable PMP.
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