Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intestinal, Multivisceral or Modified Multivisceral Transplantation
  • Alemtuzumab
  • Tacrolimus
  • Sirolimus

Treatment groups

20 Participants
are divided into 1 treatment group