Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Inclusion Criteria: * Histological diagnosis of malignant mesothelioma * Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) * At least one evaluable or measurable CT-lesion * Availability for participating in the detailed follow-up of the protocol * Signed informed consent Exclusion Criteria: * 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