ovel Delivery of Chemotherapy for Treatment of Patients with Mesothelioma: A Feasibility Study

Phase 1

Recruiting

• Conditions: Malignant pleural mesothelioma; Cancer - Lung - Mesothelioma

• Registration Number: ACTRN12620001264976
• Lead Sponsor: I-MED Radiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-25
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified