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

October 10, 2023 updated by: Case Comprehensive Cancer Center

Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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). While outcomes are favorable for participants with disease amenable to CRS+HIPEC, the therapeutic options for participants with unresectable PMP are limited. Intestinal transplantation represents a therapeutic option in participants with unresectable PMP. Overall survival has been shown to improve with participants with unresectable PMP during an Oxford Transplant Center study. The goal of this study is to corroborate the Oxford results on an American cohort.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Disease-

      • Non-resectable PMP disease will be defined as the presence of at least one of the following conditions:

        • 1) Extensive small bowel serosa involvement, where it is not possible to preserve at least 1.5-2 m of small bowel
        • 2) Extensive infiltration of the pancreatic surface
        • 3) Mesenteric involvement causing retraction
        • 4) Need for complete gastric resection
        • 5) Urete1ic obstruction
        • 6) Liver disease with no chance to achieve R0 resection with liver remnant volume > 30%
        • 7) Recurrent disease not amenable to further resection

  • Subjects do not have any other available curative treatment options.

    • Subjects can have previous abdominal operations, including CRS+HIPEC.

  • Age ≥ 18 and ≤ 75.

    • Pediatric participants were excluded as PMP is a disease that affects adults. Participants > 75 years of age are excluded as they are beyond the commonly accepted transplantability criteria.
  • Performance status ECOG ≤ 1.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • 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.
  • Subjects who are HIV-positive may be included in the study. HIV testing is required for the study as adequate HIV treatment is required prior to intestinal transplant due to the increased risk of infection following transplantation and treatment with immunosuppressive agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intestinal, Multivisceral or Modified Multivisceral Transplantation
Participants will undergo intestinal or modified multivisceral transplantation according to their disease extent. Participants will be followed for 12 months from the day of transplantation. Participants will undergo routine clinical follow-up according to standard protocols for the management of participants after visceral organ transplantation and standard oncological follow-up for participants with PMP.
Procedure: Intestinal, 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
Drug: Alemtuzumab
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.
Drug: Tacrolimus
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.
Drug: Sirolimus
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Rate of Survival
Time Frame: 12 months post operative
To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.
12 months post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Rate of Morbidity
Time Frame: 90 days post operative
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.
90 days post operative
Overall Rate of Morbidity
Time Frame: 12 months post operative
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.
12 months post operative
Overall Rate of Mortality
Time Frame: 12 months post operative
Determine cancer-related and transplant-related mortality after intestinal or multivisceral transplantation in participants with unresectable PMP.
12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Anil Vaidya, MD, Cleveland Clinic Digestive Disease & Surgery Institute (DDSI) , Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE7Z23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As an investigator-initiated protocol, individual participant data will not need to be shared with any other third party. Reported results from this trial will be aggregated data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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