This is a prospective phase II study investigating well-known antimetabolite (doxorubicin) and antiepileptic (valproate) drugs, in combination, for the treatment of refractory or recurrent malignant mesothelioma for which no active treatment is available in this indication.
Conditions
Sponsors
European Lung Cancer Working Party
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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
Exclusion criteria
Exclusion criteria: - Patients who are candidates for surgery with curative intent - Patient who were previously treated with anthracyclin derivatives - Performance status 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine, by an academical non-commercial trial, the response rate of the combination of valproate acid and doxorubicin in patients with unresectable malignant mesothelioma failing after at least one previous chemotherapy regimen including platinum derivatives according to local policy.;Secondary Objective: - to determine survival rates - to assess the toxicity of the combination of valproate acid and doxorubicin - to determine the value of the PET based response assessment. - to establish the prognostic value of FDG-PET. - to obtain tissue and serum samples for further biomarkers assessment ;Primary end point(s): To determine the response rate of the combination of valproate acid and doxorubicin in patients with unresectable malignant mesothelioma failing after at least one previous chemotherapy regimen including platinum derivatives according to local policy. | — |
Countries
Belgium
Outcome results
None listed