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Procedure

Organ Transplant for Peritoneal Cancer (TRANSCAPE Trial)

Phase 2

Waitlist Available

Led By Anil Vaidya, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PMP disease is extensive and not amenable to operative management, with or without liver, pancreas, stomach, or abdominal wall involvement

Participants > 75 years of age are excluded as they are beyond the commonly accepted transplantability criteria

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post operative

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the benefits and risks of intestinal/multi-organ transplants for people with a certain condition that can't be treated otherwise. Follow-ups for 12 months will assess results.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, potential organ inflammation from transplant rejection reactions, medication-related blood cell changes, digestive disturbances due to the drugs used post-transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am younger than 75 years old.

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My condition is confirmed as pseudomyxoma peritonei.

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My pancreas is extensively affected by cancer.

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My cancer has spread to the tissue that holds my intestines in place.

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I need surgery to remove my entire stomach.

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I have a blockage in my ureter.

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My liver disease cannot be fully removed by surgery, leaving over 30% of the liver.

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My small bowel is extensively affected and cannot preserve 1.5-2 meters of it.

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I have no other curative treatment options available.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I am an adult.

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My cancer has returned and cannot be removed with surgery.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Select...

My cancer started in the peritoneum but is not pseudomyxoma peritonei (PMP).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Rate of Survival

Secondary study objectives

Overall Rate of Morbidity

Overall Rate of Mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

2013

Completed Phase 4

~2750

Alemtuzumab

2004

Completed Phase 4

~1880