Organ Transplant for Peritoneal Cancer

(TRANSCAPE Trial)

Overseen By Anil 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for pseudomyxoma peritonei (PMP), a rare abdominal cancer, using organ transplants such as intestinal or multivisceral transplants. The trial aims to evaluate the effectiveness and safety of these transplants for individuals whose PMP cannot be treated with surgery or other standard methods. Suitable candidates have been diagnosed with PMP that is spreading within the abdomen but not beyond it, except possibly to the lungs, and cannot be surgically removed. Researchers will closely monitor participants for a year after the transplant to assess their progress and health. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that intestinal and multivisceral transplants are being studied as treatments for certain hard-to-treat cancers. In past studies, doctors performed these transplants for conditions like peritoneal cancer, proving their technical feasibility.

A report from the Intestinal Transplant Registry indicates that these transplants can be done safely. However, like any major surgery, they carry risks. Common side effects include infections or problems with organ acceptance. Despite these risks, doctors closely monitor the procedures and follow strict guidelines to manage any issues.

Overall, while risks exist, past patients have demonstrated that these transplants can be well-tolerated. Participants in these studies received regular check-ups to ensure safety and address complications. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about organ transplantation as a treatment for peritoneal cancer because it offers a unique approach by replacing affected organs entirely. Unlike traditional treatments like surgery, chemotherapy, or HIPEC (heated intraperitoneal chemotherapy), which focus on removing or attacking cancer cells while preserving organs, this method involves transplanting healthy intestinal or multivisceral organs. This could potentially eliminate cancerous tissues and restore normal organ function. This comprehensive strategy may provide new hope for patients with extensive disease spread that cannot be managed effectively with current therapies.

What evidence suggests that intestinal or multivisceral transplantation might be an effective treatment for peritoneal cancer?

Research has shown that intestinal and multivisceral transplants, which participants in this trial may undergo, offer hope for patients with peritoneal cancer when other treatments aren't possible. In studies with patients who had similar conditions, those who received these transplants lived longer. Reports from an Intestinal Transplant Registry highlight successful outcomes, with many patients experiencing extended survival after their transplants. However, some patients did face complications such as infections or intestinal problems post-surgery. Overall, the transplant can provide hope when other treatments fail. ^{1 2 3 4 6}

Who Is on the Research Team?

Anil Vaidya, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intestinal, Multivisceral or Modified Multivisceral Transplantation Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. intestinalfailurejournal.org intestinalfailurejournal.org/article/S2950-4562(25)00116-2/pdf

Intestinal Transplantation for End-Stage Pseudomyxoma ... The primary outcome was patient survival, with secondary outcomes including trans- plantation and infection within 3 months. Results: Among the 20 patients (10 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06084780?term=peptide

Intestinal & Multivisceral Transplantation for Unresectable ... 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 ...

3. researchgate.net researchgate.net/publication/318155766_Extending_the_Indications_of_Intestinal_Transplantation_-_modified_multivisceral_transplantation_for_end-stage_pseudomyxoma_peritoneii

Extending the Indications of Intestinal Transplantation In a recent review, out of the eight patients treated with SBMT, three died in the post-operative period for intestinal fistula and graft versus ...

4. ctv.veeva.com ctv.veeva.com/study/intestinal-multivisceral-transplantation-for-unresectable-mucinous-carcinoma-peritonei-transcape

Intestinal & Multivisceral Transplantation for Unresectable ... The goal of this prospective phase 2 study is to assess the efficacy and safety of intestinal or multivisceral transplantation for ...

5. positivehealthcare.net positivehealthcare.net/wp-content/uploads/2025/01/Small-Bowel-Small-Bowel_Liver-and-Multivisceral-Transplantation-12.16.2024.pdf

Clinical UM Guideline - Positive Healthcare In an Intestinal Transplant Registry (ITR) report, Grant and colleagues (2005) analyzed data for intestine, small bowel/liver and multivisceral transplants ...

6. gut.bmj.com gut.bmj.com/content/65/Suppl_1/A106.2

PTU-105 Cytoreductive Surgery and Small Bowel ... From this preliminary series, cytoreductive surgery followed by multi-visceral small bowel transplantation is technically feasible for endstage PMP.