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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Mucinous tumour or pseudomyxoma peritonei (target lesion or free intraperitoneal) as identified on prior histology or radiology

• Considered at high risk for repeat surgery, or do not wish to explore repeat surgery and consent to the trial procedures

• Considered suitable for the trial based on multidisciplinary team meeting review

Exclusion Criteria:

• Non-mucinous tumour recurrences (hard tumour)

• Suspected fistulation of the tumour into the gastrointestinal tract, invading or abutting major vessel or other area of concern (fistulation into bladder or vaginal cuff is not an exclusion for treatment)

• Known allergy (anaphylaxis) to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine

• Coagulation disorders of any kind or are on anticoagulant or anti-platelet therapy that cannot be managed or withheld for the treatment period

• Signs of an infected tumour (pus on aspiration or indicated on blood test)

• Eastern Cooperative Oncology Group (ECOG) score >2

• Other serious co-morbidities where inclusion in the trial will subject the patient to a higher risk of adverse events

• Unable to provide 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 have a tumour that is not percutaneously accessible