An Open Label Phase II Multicentre Clinical Trial of Single Agent VELCADETM (Bortezomib) in Patients with Malignant Pleural Mesothelioma - Phase II Velcade Mesothelioma Trial

All Ireland Cooperative Oncology Research Group0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年8月12日

研究概览

暂无简介。

•Histopathological evidence of MPM
•2) Performance status ECOG 0-2.
•3) Adequate haematological status:
•a) Haemoglobin 10g/dl or greater.
•b) White cell count 1 x 109/L or greater, neutrophil count 1.5 x 109/L or greater.
•4) Platelets 100 x 109 /L or greater.
•5) Adequate hepatic function (AST and ALT < 3 x upper limit of normal).
•6) Willing to give written informed consent to participate. Translational research will be dealt with by a separate informed consent form.
•7) Where possible, pleural effusions should be drained before treatment. For uncontrollable pleural effusions (recurrent despite regular drainage), talc or tetracycline pleurodesis may be offered as per standard practice.
•8) Male subject agrees to use an acceptable method of birth control for the duration of the study and contraception must be used by women of child bearing potential

•1)Enrollment in another clinical trial.
•2) The patient has a history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years, or the tumour was a non-melanoma skin tumour or in-situ cervix carcinoma.
•3) Symptomatic or known Brain or leptomeningeal metastases.
•4) Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 10, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
•5) Patients may not have received more than 1 prior line of anti-neoplastic treatment for MPM.
•6) Prior exposure to VELCADE.

发起方

All Ireland Cooperative Oncology Research Group