Overview

Injection of Bromelain and Acetylcysteine in Combination Into Recurrent Mucinous Tumour or Pseudomyxoma Peritonei

Status:
Not yet recruiting

Trial end date:
2021-11-01

Target enrollment:

Participant gender:

Summary

This study involves 100 patients with mucinous peritoneal tumour, including pseudomyxoma peritonei (PMP), that are not suitable for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) or other potentially beneficial surgery. The combination drug treatment of Bromelain and Acetylcysteine (BromAc) will be administered directly into the tumour or peritoneal cavity via percutaneous drain and allowed to dwell for 24 hours. The tumour will then be drained and a repeat treatment will be considered. An interventional radiologist will insert a percutaneous drain. The drain will remain in situ for the treatment period. The aspiration (drainage) and repeat drug treatments will be delivered via this drain. The dose of the drug is dependent on the calculated tumour dimensions and volume outlined in the protocol. The expectation is that the drug combination will dissolve the tumour, allowing it to be removed. Remaining mucinous tumour that is unable to be drained will be considered for repeat drug treatments.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

David Morris

Collaborators:

Catharina Ziekenhuis Eindhoven
Hospices Civils de Lyon
Memorial Sloan Kettering Cancer Center
Mercy Medical Center
St George Hospital, Australia
ThermaSolutions Inc.
Wake Forest University
Wake Forest University Health Sciences

Treatments:

Acetylcysteine
N-monoacetylcystine