A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma

Inclusion Criteria:

* Age of \> 18 years and \< 72 years
* Patients with a histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing either PDFGR-beta or C-Kit by immunochemistry (ICH)
* Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease
* Confirmed progression of the disease according to modified REcist-criteria, documented after a first-line, systemic (premetrex+cisplatin regimen) or local treatment (i.e., intrapleuric)
* ECOG Performance Status of 0, 1 or 2
* Life expectancy of at least 3 months
* Capability of understanding the objectives of the study and giving written informed consent
* Willingness and ability to comply with study requirements
* Sufficient caloric and fluid intake, including patients under enteral or parenteral nutrition

Exclusion Criteria:

* Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma
* A history of earlier tumors of different histologic origin being in complete remission since less than 5 years
* Unresolved toxicity from prior antitumor treatment(s)
* Primary peritoneal mesothelioma
* Any of the following abnormal baseline hematological values:

  * Hb \< 9 g/dL
  * WBC \< 3 x 109/L
  * Neutrophils \< 1.5 x 109/L
  * Platelets \< 100 x 109/L
  * Serum bilirubin \> 2.5 mg/dL
  * ALAT and ASAT \> 3 x UNL (unless due to liver metastases)
  * Serum creatinine \> 1.5 mg/dL
* Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more
* History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
* Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
* Uncontrolled active infections
* Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study