To find activity in this new class of drugs
ID
Source
Brief title
Condition
- Mesotheliomas
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PRIMARY ENDPOINT
Response rate. Continued accrual during the trial will be based upon the
objective response rates in the first stage of the two-stage design for
patients treated in the first or second-line settings.
Secondary outcome
SECONDARY OUTCOMES
Progression-free survival, Overall Survival.
Background summary
Malignant pleural mesothelioma (MPM) is an aggressive, rapidly lethal thoracic
malignancy causally associated with asbestos exposure that is increasing in
incidence in the UK and Europe. Systemic therapy is the mainstay of management;
however, there exists no agreed standard of combination chemotherapy. MPM
exhibits major de novo chemoresistance, probably associated with underlying
defective apoptosis signalling. Novel strategies for treating this disease are
urgently needed.
Velcade (Bortezomib) is a first-in-class proteosome inhibitor, now licensed for
use in myeloma. Preclinical studies from Mutti and colleagues have demonstrated
significant activity of single agent velcade against MPM xenografts,
necessitating its clinical evaluation in both the first and second line
settings.tly needed if survival is to be improved.
Study objective
To find activity in this new class of drugs
Study design
Multicentre, international, non-randomised phase II clinical trial using
Simon*s 2-Stage Optimal Design.
Intervention
Bortezomib 1.6mg/m2 intravenous administration on days 1, 8, 15, 22 of a 35 day
cycle, for a total of 4 cycles (20 weeks) with the option to continue therapy
in responding patients until progression (at the investigators discretion).
Study burden and risks
visiting the hospital for chemotherapy and the possible side effects.
When patients give informed consent an additional puncture of the pleural tumor
will be performed an two vials of blood will be examined
120 Penbrooke Road
Dublin 4
IE
120 Penbrooke Road
Dublin 4
IE
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-004420-39-NL |
| CCMO | NL12228.031.06 |