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

Primary Purpose

Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum, Pseudomyxoma Peritonei

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intestinal, Multivisceral or Modified Multivisceral Transplantation
Alemtuzumab
Tacrolimus
Sirolimus
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Malignant Neoplasm of Retroperitoneum focused on measuring Intestinal Transplantation, Multivisceral Transplantation, Pseudomyxoma Peritonei, Unresectable Mucinous Carcinoma Peritonei, TRANSCAPE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intestinal, Multivisceral or Modified Multivisceral Transplantation

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Rate of Survival
To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.

Secondary Outcome Measures

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.

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT06084780
Brief Title
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Acronym
TRANSCAPE
Official Title
Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum, Pseudomyxoma Peritonei
Keywords
Intestinal Transplantation, Multivisceral Transplantation, Pseudomyxoma Peritonei, Unresectable Mucinous Carcinoma Peritonei, TRANSCAPE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intestinal, Multivisceral or Modified Multivisceral Transplantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intestinal, Multivisceral or Modified Multivisceral Transplantation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Rate of Survival
Description
To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.
Time Frame
12 months post operative
Secondary Outcome Measure Information:
Title
Overall Rate of Morbidity
Description
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.
Time Frame
90 days post operative
Title
Overall Rate of Morbidity
Description
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.
Time Frame
12 months post operative
Title
Overall Rate of Mortality
Description
Determine cancer-related and transplant-related mortality after intestinal or multivisceral transplantation in participants with unresectable PMP.
Time Frame
12 months post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anil Vaidya, MD
Phone
216-445-3041
Email
VAIDYAA2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Vaidya, MD
Organizational Affiliation
Cleveland Clinic Digestive Disease & Surgery Institute (DDSI) , Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Vaidyaa, MD
Phone
216-445-3041
Email
VAIDYAA2@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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