Injection of Bromelain and Acetylcysteine in combination into recurrent mucinous tumour or pseudomyxoma peritonei: a phase I/II study

Phase 1

Recruiting

• Conditions: pseudomyxoma peritonei; recurrent pseudomyxoma peritonei; peritoneal disease; low grade appendix tumour; Cancer - Other cancer types

• Registration Number: ACTRN12617001612303
• Lead Sponsor: Professor David Morris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-08
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with PMP or mucinous tumour who are not candidates for CRS/HIPEC or other surgery, have soft to intermediate grade tumour and do not meet any exclusion criteria

Patients will be considered for entry into this study if they:

•Are 18 – 80 years old
•Have a mucinous tumour or pseudomyxoma peritonei (target or free intraperitoneal) as identified on prior histology
•Are considered at high risk for repeat surgery, or do not wish to explore repeat surgery and consent to the trial procedures
•Have soft to intermediate grade tumour as identified on prior histology or operation
•Are considered suitable for the trial based on multidisciplinary team meeting review

Tumour should not be hard tumour or caking and have a clear cystic or mucinous appearance as identified on radiology. Having hard tumour in one region does not exclude treatment in another area, provided the appearance is mucinous.

In the case of a target lesion, tumour located elsewhere will not exclude a patient from this study and these tumours may be treated if suitable. The tumour must be safely accessible percutaneously by an interventional radiologist to allow insertion of a catheter or drain

Exclusion Criteria

Exclusion criteria

Patients will be excluded from the study if they:

•Have a non-mucinous tumour recurrence (hard tumour)
•Have suspected fistulisation of the tumour into the gastrointestinal tract, invading or abutting major vessel or other area of concern
•Have an allergy to pineapples, papain or bromeliads, sulphur or Acetylcysteine (skin tests will be performed in any patient where allergy or sensitivity is unknown)
•Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that can not be managed or withheld for the treatment period
•Are asthmatic
•Have infected tumour (pus on aspiration or indicated on blood test)
•Have other serious comorbidities where inclusion in the trial will subject the patient to a higher risk of adverse events
•Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial
•Considered by the interventional radiologist to not be percutaneously accessible

Study & Design

• Study Type: Interventional
• Study Design: Not specified