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

• Conditions: 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.

• Registration Number: EUCTR2006-001443-63-BE
• Lead Sponsor: European Lung Cancer Working Party

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-03
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 41

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- to assess the toxicity of the combination of valproate acid and doxorubicin<br>- to determine the value of the PET based response assessment. <br>- to establish the prognostic value of FDG-PET.<br>- 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.