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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 111

Inclusion Criteria

1) Histopathological evidence of MPM
2) Performance status ECOG 0-2.
3) Adequate haematological status:
3a) Haemoglobin 10g/dl or greater.
3b) White cell count 1 x 10(9)/L or greater, neutrophil count 1.5 x 10(9)/L or greater.
4) Platelets 100 x 10(9) /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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Any of the inclusion criteria are not met
2) Enrollment in another clinical trial.
3) 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.
4) Symptomatic or known Brain or leptomeningeal metastases.
5) 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.
6) Patients may not have received more than 1 prior line of anti-neoplastic treatment for MPM.
7) Prior exposure to VELCADE.
8) Pregnant or breastfeeding.
9) Neuropathy Grade 2.
10) Preplanned surgery or procedures that would interfere with the conduct of the study.
11) Receipt of extensive radiation therapy, systemic chemotherapy, or other anti-neoplastic therapy within 4 weeks before enrollment.
12) Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection,) or psychiatric illness likely to interfere with participation in this clinical study.
13) Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. Concurrent participation in any treatment studies is not allowed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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