Study on Intestinal and Multivisceral Transplantation for Treating Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06084780

Provider View

This clinical trial is exploring the use of intestinal or multivisceral transplantation as a treatment for patients with pseudomyxoma peritonei (PMP), a rare type of cancer that cannot be treated with other curative methods. The study will follow participants for 12 months to evaluate the safety and effectiveness of the transplant.

Patient Parameters

Program Overview

The purpose of this study is to test whether intestinal or multivisceral transplantation can be a safe and effective treatment for people with pseudomyxoma peritonei (PMP), a rare cancer that causes a buildup of mucus in the abdomen. This condition can lead to severe symptoms like abdominal swelling, bowel blockage, and malnutrition. Traditional treatments like surgery and chemotherapy work well for some, but not for those whose disease cannot be surgically removed. This study aims to see if transplantation can help these patients, building on promising results from a previous study in Oxford.

Description

Pseudomyxoma peritonei (PMP) is a rare condition that affects about 2-4 people per million. It involves the spread of mucus-producing tumors in the abdomen, leading to symptoms like swelling, bowel blockage, and weight loss. If left untreated, it can be life-threatening. While some patients benefit from surgery and chemotherapy, others have tumors that cannot be removed. This study is testing whether a transplant of the intestines or multiple organs can help these patients. Previous research from Oxford showed improved survival rates for patients who received transplants. This study will see if similar results can be achieved in the United States. Participants will undergo the transplant procedure and be monitored for a year to assess the treatment's safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of pseudomyxoma peritonei (PMP), either low-grade or high-grade, with or without specific cell types, and whether it's a first occurrence or a recurrence.
  • The cancer must not have spread outside the abdomen, except possibly to the lungs.
  • The disease must be extensive and not treatable with surgery, possibly involving the liver, pancreas, stomach, or abdominal wall.
  • Must meet specific criteria for non-resectable disease, such as:
    • Extensive involvement of the small bowel, making it impossible to preserve enough bowel.
    • Significant involvement of the pancreas or other organs.
    • Recurrent disease that cannot be surgically removed again.
  • No other curative treatment options available.
  • Previous abdominal surgeries, including certain cancer treatments, are allowed.
  • Age between 18 and 75 years old.
  • Must be in good general health with a performance status score of 0 or 1.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cancer originating from a cause other than pseudomyxoma peritonei (PMP).
  • Currently receiving other experimental treatments.
  • Have uncontrolled health issues like infections, heart problems, or mental health conditions that could interfere with the study.
  • Pregnant women cannot participate due to the risks associated with the transplant procedure.
  • HIV-positive individuals can participate if they are receiving adequate treatment, as the transplant increases infection risk.

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