None listed
Conditions
Brief summary
Malignant pleural mesothelioma (MPM) is a rare cancer of the lung lining caused by exposure to asbestos. MPM is regarded as one of the most aggressive solid tumours, with limited treatment options and poor prognosis. Emerging MPM treatment options are of particular interest in Australia where the incidence of MPM is among the highest in the world. One such emerging treatment involves the injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. This approach, termed transarterial chemoperfusion, allows a high concentration of chemotherapy to be delivered directly to the cancer. This study is investigating the safety and effectiveness of transarterial chemoperfusion for the treatment of patients with MPM. We will evaluate tumour response, symptoms, quality of life, progression free survival and overall survival. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been diagnosed with malignant pleural mesothelioma that is not being treated with surgery and you have not had recent chemotherapy (within the last 4 weeks). Study details Participants enrolled in this study will undergo an angiogram (imaging of the heart and blood vessels), which involves having a catheter inserted into a vein. The chemotherapy agents will then be directly infused into the aorta and surrounding blood vessels over a period of 60 minutes. All participants will be receive this treatment for at least 2 sessions scheduled every 3-6 weeks, before undergoing a CT scan to assess treatment response. Participants who show a reduction in their tumour burden will continue to receive therapy every 3-6 weeks until they no longer respond to treatment. Participants who do not show a response to treatment after the first 2 procedures will not undergo further infusion therapy. It is hoped this research will determine whether this specific method of chemotherapy infusion is a safe and effective treatment for patients with malignant pleural mesothelioma, and can improve outcomes for future patients.
Interventions
Patients will undergo an angiogram and transarterial chemoperfusion procedure approximately 60 minutes in length, which involves injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. The chemotherapy agents will be administered into the thoracic aorta and/or the intercostal arteries and/or the internal mammary artery on the side of the disease. The chemotherapy agents and dosage utilised will include the following; cisp
Patients will undergo an angiogram and transarterial chemoperfusion procedure approximately 60 minutes in length, which involves injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. The chemotherapy agents will be administered into the thoracic aorta and/or the intercostal arteries and/or the internal mammary artery on the side of the disease. The chemotherapy agents and dosage utilised will include the following; cisplatin (35 mg/m^2 body surface area (BSA)), methotrexate (100 mg/m^2 BSA) and gemcitabine (1000 mg/m^2 BSA). All agents used and dosage will remain the same for all patients with modification at the discretion of the MDT meeting members (treating physicians). Patients will attend Wesley Medical Imaging for repeat chemoperfusion treatment every 4 weeks (3-6 week interval allowed), if clinically appropriate, until disease progression is confirmed AND there is no evidence of a treatment response on follow-up CT scans. Follow-up CT scan will be performed every 12 weeks, or earlier if deemed clinically necessary, to monitor response to treatment. As per the international guidelines response to treatment will be de?ned as per the Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma.
Sponsors
I-MED Radiology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Histologically or cytologically confirmed MPM. • Tumour/s assessed as inoperable or refuses surgery. • The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment. • Failure to respond to first line standard of care chemotherapy. • Have measurable disease, by computed tomography (CT) as per modified Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma. • Ability to understand and the willingness to sign a written informed consent document. • Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study. • An ECOG performance status score <3. • Patient is expected to survive and be available for follow up for at least 12 months. • Patients must have private health insurance to be included in this trial and eligible for treatment at The Wesley Hospital.
Exclusion criteria
• Large pulmonary-systemic shunting of tumour vasculature, as demonstrated on preliminary angiogram. • Patients who have had chemotherapy within 4 weeks prior to entering the study. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, methotrexate, gemcitabine or other agents used during the study. • History of moderate and severe allergic reaction to intravenous iodinated contrast media is not a contraindication to the study. • Involvement in trials with other investigational agents. • Patient with synchronous primary tumours requiring other therapy. • Uncontrolled intercurrent illness including, but not limited to, renal dysfunction, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. • Women who are pregnant or lactating.
Outcome results
None listed