Organ Transplant for Peritoneal Cancer
(TRANSCAPE Trial)

Overseen ByAnil Vaidya, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Non-PMP cancer, Active infection, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on investigational agents, you cannot participate in the trial.

Is multivisceral transplantation generally safe for humans?

Multivisceral transplantation, which involves replacing multiple abdominal organs, has shown improved patient survival rates over the years due to advances in surgical techniques and immunosuppressive treatments. However, there are still risks, including infection and organ rejection, which have been the leading causes of complications and mortality in patients.¹ ² ³ ⁴ ⁵

How is multivisceral transplantation different from other treatments for peritoneal cancer?

Multivisceral transplantation is unique because it involves transplanting multiple abdominal organs at once, such as the stomach, intestine, and pancreas, which is not typical for treating peritoneal cancer. This approach is usually considered when other treatments are not viable, and it has shown improved survival rates over time due to advances in patient selection and immunosuppression.³ ⁶ ⁷ ⁸ ⁹

Research Team

Anil Vaidya, MD

Principal Investigator

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

Eligibility Criteria

This trial is for adults aged 18-75 with unresectable pseudomyxoma peritonei (PMP), a type of abdominal cancer, without extra-abdominal metastases except possibly in the lungs. Candidates must have no other curative treatment options and be physically able to undergo transplantation. Pregnant women, those over 75, or with certain serious health issues are excluded.

Inclusion Criteria

My condition cannot be treated with surgery.

My PMP cancer cannot be removed by surgery and may involve my liver, pancreas, stomach, or abdominal wall.

I am younger than 75 years old.

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Exclusion Criteria

I do not have any severe illnesses or social situations that could affect my study participation.

I am not pregnant, as pregnancy excludes me from this study.

I am HIV-positive and willing to undergo HIV testing for the study.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo intestinal or modified multivisceral transplantation according to their disease extent

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after transplantation

12 months

Routine clinical follow-up according to standard protocols

Treatment Details

Interventions

Alemtuzumab
Intestinal, Multivisceral or Modified Multivisceral Transplantation
Sirolimus
Tacrolimus

Trial Overview The TRANSCAPE study tests intestinal or multivisceral transplantation's effectiveness and safety in treating PMP that can't be surgically removed. Patients will receive transplants followed by drugs like Tacrolimus, Alemtuzumab, and Sirolimus to prevent organ rejection.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Intestinal, Multivisceral or Modified Multivisceral TransplantationExperimental Treatment4 Interventions

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.