BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei

PHASE2UnknownINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 31, 2022

Primary Completion Date

November 30, 2023

Study Completion Date

February 29, 2024

Conditions
Pseudomyxoma PeritoneiPeritoneal CancerMucinous AdenocarcinomaMucinous 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 (1)

All Listed Sponsors
collaborator

Mercy Medical Center

OTHER

collaborator

Wake Forest University Health Sciences

OTHER

collaborator

University of Pittsburgh Medical Center

OTHER

collaborator

Catharina Ziekenhuis Eindhoven

OTHER

collaborator

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

lead

Mucpharm Pty Ltd

INDUSTRY