A phase II study assessing the activity of valproate acid plus doxorubicin in refractory or recurrent malignant mesothelioma.

European Lung Cancer Working Party0 个研究点目标入组 41 人开始时间: 2006年4月3日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•- Histological diagnosis of malignant mesothelioma
•- Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) according to local policy.
•- At least one evaluable or measurable CT-lesion
•- Availability for participating in the detailed follow-up of the protocol
•- Signed informed consent.
•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

•- Patients who are candidates for surgery with curative intent
•- Patient who were previously treated with anthracyclin derivatives
•- Performance status < 60 on the Karnofsky scale
•- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
•- A history of prior HIV infection
•- Polynuclear cells < 2,000/mm³
•- Platelet cells < 100,000/mm³
•- Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
•- Serum bilirubin >1.5 mg/100 ml
•- Transaminases more than twice the normal range
•- Serum creatinine > 1.5 mg/100 ml
•- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
•- Congestive cardiac failure (ejectional fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia
•- Uncontrolled infectious disease
•- Active epilepsy needing a specific treatment
•- Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
•- Pregnancy or refusal to use active contraception
•- A known allergy to valproate acid and/or doxorubicin
•- Serious medical or psychological factors which may prevent adherence to the treatment schedule.

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