Clinical Trials for Mesothelioma Patients: Valproate and Doxorubicin Patient Exclusion Criteria

Read about the patient exclusion criteria for a current clinical trial being conducted to study Valproate and Doxorubicin in patients who have been diagnosed with mesothelioma. At this time, the study is only being conducted in Belgium and France. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

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

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