Patients with inoperable pseudomyxoma peritonei or peritoneal mucinous tumour that meet the entry criteria and consent to the intervention will receive intratumoural or intraperitoneal treatment/s with the combination experimental drug treatment BromAc. The drug will be injected directly into the tumour or free intraperitoneally via a percutaneously radiologically placed drain.

Pseudomyxoma Peritonei

Peritoneal Cancer

Mucinous Adenocarcinoma

Mucinous Tumor

Intratumoural injections of Bromelain 15-45mg (concentration 600ug/ml) or intraperitoneal injections of Bromelain 60mg will be administered via a radiologically placed drain in combination with Acetylcysteine in 0.9% sodium chloride (normal saline).

Bromelain, Stem

Intratumoural injections of Acetylcysteine 1g or intraperitoneal injections of Acetylcysteine 2g will be administered via a radiologically drain in combination with Bromelain in 0.9% sodium chloride (normal saline).

Acetylcysteine

Under radiological guidance (CT), a needle, wire, dilator will be placed directly into the tumour then a large pigtail drain (i.e. 10Fg) will be placed into the tumour by an experienced, interventional radiologist, under standard procedures.

Interventional radiology insertion of drain

Blood tests are taken 3 hours after each drug intervention then 24 hours following the last drug intervention to assess for short-term systemic side effects and measure pharmacokinetics of bromelain and acetylcysteine.

Pathology: blood testing during intervention

Patients will have outpatient reviews at 1 week and 1, 3, 6, 9 and 12 months post drug intervention. Blood tests will be performed at 1 week and 1, 3, 6, 9 and 12 months after the drug intervention to assess for short and long term systemic side effects. At 1, 3, 6, 9 and 12 months post drug intervention, a CT-scan is part of the study protocol to assess for response and progression of disease.

Routine follow up

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

Tumour changes following BromAc combination treatment. Efficacy will be measured by the volume of fluid aspirated from the drain (dissolved tumour). The treatment will be seen effective if >25% of tumour volume is aspirated or there is a >30% reduction on CT scan post treatment at 1 month compared to the pre-treatment scan.

Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered BromAc, and judged possibly, probably, or definitely related to treatment

Time to progression of the treated area based on repeat CT scanning where RECIST v1.1 will be used where possible. The follow up scan will be compared to the 1 month post treatment scan where dimensions and volume will be calculated by an experienced radiologist.

The EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Core - C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items.
The global health status / Quality of Life scale has scores from 1 (very poor) to 7 (excellent) and the others from 1 (not at all) to 4 (very much) where 4 is the worst score. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

The symptom scores (Fatigue, Nausea and vomiting, Pain …), with scores from 1 (not at all) to 4 (very much), where 4 is the worst score, will be evaluated by the use of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer (EORTC-QLQ-CR29). The trend of each category of outcome measures given by the EORTC-QLQ-CR29 in four groups of patients: tumour on the right and transverse part of the colon; tumour on the left part of the colon; rectal tumour; metastatic colorectal cancer.

David Morris

Professor of Surgery, Director

Mercy Medical Center

Wake Forest University Health Sciences

St George Hospital, Australia

Memorial Sloan Kettering Cancer Center

Catharina Ziekenhuis Eindhoven

Hospices Civils de Lyon

Patient will receive HIPEC in the form of Cisplatin 100mg/m2. 5. HIPEC will be provided at completion of surgical cytoreduction. The chemotherapy will be ordered by the treating gynecologic oncologist. It will be prepared in the chemotherapy pharmacy and delivered to the operating room once the surgeon confirms optimal cytoreduction and eligibility. Patients undergoing bowel resection will be left with bowel in discontinuity during the HIPEC infusion cycle. The abdomen will be temporarily closed with skin staples to prevent spillage of the perfusate. HIPEC will be delivered using the closed technique as has been well described.

Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Carcinoma

Heated Intraperitoneal Chemotherapy will be administered after the completion of interval cytoreductive surgery after three cycles of neoadjuvant chemotherapy.

Cisplatin

Long Island Jewish Medical Center

HIPEC After Initial CRS in Patients Who Have Received NACT

A Pilot Study of Heated Intraperitoneal Chemotherapy (HIPEC) After Interval Cytoreductive Surgery (CRS) in Patients Who Have Received Neoadjuvant Chemotherapy (NACT) for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Severity of adverse events will be evaluated using the NCI Common Terminology Criteria for Adverse Events version 4.0 [NCI CTCAE v4.0]. AEs will be classified as possibly, probably, or definitely related to study treatment.

Physical examinations, vital signs, hematologic and clinical parameters, measured monthly for 12 months after initial study treatment or subject discontinuation, whichever comes first.

Time from surgery date to death due to any cause.

Time from surgery date to the first documentation of disease progression or death due to any cause.

pseudomyxoma peritonei/qusma

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

HIPEC After Initial CRS in Patients Who Have Received NACT

Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası