BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei

Summary

Pseudomyxoma peritonei (PMP) is an orphan disease, characterized by the progressive accumulation of jelly-like material within the abdomen, which occurs in approximately 2-3 people per million per year. Advanced disease is often the result of tumour perforation and seeding of tumour cells within the peritoneal cavity. Complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CCRS HIPEC) is the current standard of care for PMP.

An Australian pharmaceutical company is developing BromAc for diseases involving mucin. This drug is composed of Bromelain and Acetylcysteine. During pre-clinical development, the sponsor found that BromAc rapidly dissolved and removed tumour mucin, making it a potent mucolytic. BromAc in combination have the ability, as shown in pre-clinical studies, to remove the mucin protective framework expressed by cancer including mucin (MUC) 1, MUC2, MUC4, MUC5AC and MUC16. The sponsor has shown the mechanism of action of BromAc - to break peptide and glycosidic linkages and disulphide bonds in tumour produced and respiratory mucin. BromAc has been safe in preclinical development with a manageable adverse event profile and preliminary efficacy in a phase 1 study.

This current study will examine the efficacy and safety of applying BromAc directly into recurrent mucinous tumour deposits in patients that are found to be unsuitable for repeat curative intent intervention by CCRS HIPEC.

Conditions

• Pseudomyxoma Peritonei
• Peritoneal Cancer
• Mucinous Adenocarcinoma
• Mucinous Tumor

Interventions

DRUG

Bromelain

Intratumoural injections of Bromelain 600ug/ml (maximum dose 90mg daily diluted in 150ml 0.9% NaCl) via a radiologically placed drain in combination with Acetylcysteine in 0.9% sodium chloride (normal saline).

DRUG

Acetylcysteine

Intratumoural injections of Acetylcysteine 20mg/ml (maximum dose 3g daily diluted in 150ml 0.9% NaCl) via a radiologically placed drain in combination with Bromelain.

PROCEDURE

Interventional radiology insertion of drain

Under radiological guidance (CT), a needle, wire, dilator will be placed directly into the tumour, then a pigtail drain (10Frg) will be secured into the tumour by an experienced, interventional radiologist, under standard procedures. This drain is utilised as access to the tumour for injections of the investigational drug product BromAc, and subsequent aspirations.

Sponsors & Collaborators

• Mercy Medical Center

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Mucpharm Pty Ltd

  lead INDUSTRY

Principal Investigators

• Armando Sardi, MD · Mercy Medical Center, USA

• Haroon Choudry, MD · University of Pittsburgh Medical Center, USA

• Edward Levine, MD · Wake Forest University Hospital, USA

• Alvaro Arjona Sanchez, MD · University Hospital Reina Sofia, Spain

• Ignace de Hingh, MD · Eindhoven Catharina Hospital, Netherlands

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-31

Primary Completion

2023-11-30

Completion

2024-02-29

FDA Drug

Yes