Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication for Malignant Pleural Mesothelioma

Inclusion criteria:

• Patient is able to understand and willing to sign a written informed consent document.
• Male or female, age >=18 years
• ECOG performance status =2
• MPM histologically confirmed (stage cT1-cT4 cN0-cN3 cM0-cM1)
• Patient qualifying for pleurectomy/decortication (P/D) for resection of MPM, which has to be assessed during a multidisciplinary tumor board including a thoracic surgeon
• Patient must have normal organ and bone marrow function as defined: normal hematologic function (hemoglobin >=100 g/L, WBC >=3.5 x G/L, neutrophils >=1.5 x G/L, thrombocytes >=100 x G/L), total bilirubin and liver function tests within normal institutional limits, creatinine within normal institutional limits or creatinine clearance >=60 ml/min/1.73m2 for patients with creatinine concentrations above institutional normal limits.
• Patient must have an appropriate blood coagulation for P/D (Quick-test > 50%, aPTT within normal institutional limits, INR <=1.2)
• The patient agrees to use an efficient contraceptive treatment up to 3 months after cisplatin application if required (pre-menopausal women and men in a sexually mature age).
• Heart and lung function allowing P/D under general anesthesia

Exclusion criteria:

• Known or suspected unwillingness of the patient to follow the rules of the protocol
• Patient who has not recovered from side effects from prior chemotherapy or radiotherapy.
• Any known hypersensitivity against cisplatin or other platinum containing substances or any other components used for the preparation of the drugs
• Patient must not receive any other investigational agents 4 weeks before treatment and until the end of the observation period (2 months after treatment).
• Patient with prior pleurectomy
• Patient with uncontrolled intercurrent illnesses including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the operative procedure of P/D or compliance with study requirements
• Tinnitus and/or restricted power of hearing (especially in the upper frequency range) confirmed by audiometry
• Known alcohol and/or drug abuse at the time of screening
• Pregnant or lactating woman