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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post operative

Awards & highlights

TRANSCAPE Trial 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.Check my eligibility

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.See study design

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.

TRANSCAPE Trial 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.

Select...

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.

Select...

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

Select...

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.

TRANSCAPE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Rate of Survival

Secondary outcome measures

Overall Rate of Morbidity

Overall Rate of Mortality

TRANSCAPE 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

~1890

Tacrolimus

2011

Completed Phase 4

~4740

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

453 Previous Clinical Trials

31,849 Total Patients Enrolled

1 Trials studying Pseudomyxoma Peritonei

12 Patients Enrolled for Pseudomyxoma Peritonei

Anil Vaidya, MDPrincipal InvestigatorCleveland Clinic Digestive Disease & Surgery Institute (DDSI) , Case Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program open to minors?

"As this research project is open to all individuals aged 18 and above up to 75 years old."

Answered by AI

What measures are in place to ensure patient safety during Intestinal, Multivisceral or Modified Multivisceral Transplantation?

"We assign Intestinal, Multivisceral or Modified Multivisceral Transplantation a score of 2 on our safety scale. The rationale for this is that it has gone through Phase 2 clinical trials showing signs of safety but no evidence indicating efficacy yet."

Answered by AI

Is this experiment in progress and still open to participants?

"Contrary to what is reported on clinicaltrials.gov, this clinical trial is not actively enlisting participants. This study first went live on April 1st 2024 and was last modified October 10th 2023; thus it has closed its search for subjects. Nevertheless, 5517 other trials are currently searching for enrollees."

Answered by AI

Am I eligible to be included in this research venture?

"Qualified participants of this medical trial, which is seeking 20 volunteers in total, must have pseudomyxoma peritonei and should be within the age bracket of 18 to 75 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084780.

All > Peritoneal Carcinomatosis