Peritoneal Cancer Clinical Trial
Official title:
A Phase 2, Multi-centre Study of BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei
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.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | February 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Aged 18 - 80 years - Have a mucinous tumour/pseudomyxoma peritonei target lesion with a defined cavity, with the shortest diameter being at least 3 centimeters on radiology, and percutaneously accessible. In the case of a target lesion, tumour located at distant sites (for e.g. pleura) will not exclude a patient from this study and these tumours may be treated, if suitable, under expanded access protocols. - Are symptomatic or at risk of becoming symptomatic or obstructed imminently, are considered inoperable, at high risk of morbidity, mortality or quality of life decline for repeat surgery, or do not wish to explore repeat surgery - Are considered suitable for the trial based on a multidisciplinary team meeting case review Exclusion Criteria: - Have a non-mucinous tumour (hard caked tumour) that does not have cystic appearance on radiology. Having a hard tumour appearance in one region does not exclude treatment in another area, provided the appearance is mucinous. - Have suspected fistula 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) - Have known allergy (anaphylaxis) or allergy to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine or any other serious allergy or intolerance to fruits or food products - Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that cannot be managed or withheld for the radiology procedure - Have an infected tumour or ongoing inflammatory process (pus on aspiration at radiology will be a delayed failure) as indicated on baseline blood test - Eastern Cooperative Oncology Group (ECOG) score >2 - Have had chemotherapy within the last two weeks, have not had bone marrow recovery from chemotherapy, or had Bevacizumab (Avastin) within the last 4 weeks. A staging baseline scan must be completed prior to considering entry into this study. - Have previously received BromAc for pseudomyxoma or peritoneal mucinous tumour (see expanded access) - Have other serious comorbidities where inclusion in the trial will subject the participant to an unacceptable higher risk of adverse events as judged by the investigator - Pregnant women are excluded from this study because BromAc has unknown but a potential risk for adverse events in nursing infants secondary to treatment of the mother - Participants with psychiatric illness/social situations that would limit compliance with study requirements - Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Mucpharm Pty Ltd | Catharina Ziekenhuis Eindhoven, Hospital Universitario Reina Sofia de Cordoba, Mercy Medical Center, University of Pittsburgh Medical Center, Wake Forest University Health Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumour response (objective response rate) | Tumour changes following BromAc combination treatment compared to baseline. Efficacy will be measured by RECIST v1.1 with the volume of fluid aspirated from the drain (dissolved tumour). The treatment will be seen effective if >30% 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. Given the difficulty of assessing soft tumour (cystic/mucinous) response by RECIST, a surrogate assessment of efficacy will be measured (if unable to assess based on RECIST v1.1 criteria) by tumour changes following BromAc combination treatment. | 1 month | |
Secondary | Progression free survival post treatment | Time to progression of the treated area (duration of response) 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. | 1 month, 3 months, 6 months, 9 months and 12 months | |
Secondary | Impact of treatment on Quality of Life over time in patients evaluated by the core questionnaire 'European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer (EORTC-QLQ-C30)'. | 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. |
Baseline, then at 1 month, 3 months, 6 months, 9 months and 12 months | |
Secondary | Impact of treatment on Quality of Life in colorectal cancer over time by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Colorectal Cancers (EORTC-QLQ-CR29) | 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. | Baseline, then at 1 month, 3 months, 6 months, 9 months and 12 months | |
Secondary | Incidence of Treatment-Emergent Adverse Events (Pathology) [Safety and Tolerability] | 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 | 1 month | |
Secondary | Symptomatic response to treatment | Symptoms from tumour will be assessed at baseline then compared to post treatment symptoms to determine resolution or worsening of symptoms from tumour experienced. | Baseline, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months | |
Secondary | Laboratory blood test parameters | Laboratory parameters (haematology, clinical chemistry and coagulation) will be assessed at baseline then at each interval to assess for any alteration compared to baseline assessment | Baseline, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months |
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