Official Title: “A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma”

The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary:

• Response rate Every 3 courses Yes

Secondary:

• Survival Survival will be dated from the day of registration until death or last follow up No
• Toxicity After each course of chemotherapy and at the end of treatment No

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

Lead Sponsor: European Lung Cancer Working Party

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels  1000 Belgium

Department of Pneumology CHU Charleroi

Charleroi  6000 Belgium

Department of Pneumology Hôpital Saint-Joseph

Gilly  6060 Belgium

Department of Pneumology CHR St joseph - Warquignies

Boussu  7360 Belgium

CH Peltzer-La Tourelle

Verviers  4800 Belgium

Hôpital Ambroise Paré

Mons  7000 Belgium

Department of Pneumology Hôpital Ixelles-Molière

Brussels   Belgium

Department of Pneumology CHRU Lille

Lille   France

Overall Clinical Trial Officials and Contacts

Thierry Berghmans, MD Study Chair European Lung Cancer Working Party  

Overall Contact: Nathalie Leclercq, RN 0032/2/5390496 nathalie.leclercq@bordet.be

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634205

Study ID Number: ELCWP-01062

ClinicalTrials.gov Identifier: NCT00634205

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Click here for more information on the protocol

Trials registry of the French National Cancer Institute