Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma

Inclusion Criteria:

* Patients \>18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen
* Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed
* Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy
* ECOG Performance status 0 - 2
* Adequate baseline bone marrow, hepatic and renal function, defined as follows:

  * Neutrophils \> 1.5 x 10\^9/L and platelets \> 100 x 10\^9/L
  * Bilirubin \< 1.5 x ULN
  * AST and/or ALT \< 2.5 x ULN in absence of liver metastasis
  * AST and/or ALT \< 5 x ULN in presence of liver metastasis
  * Serum creatinine \< 1.5 x ULN
* Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
* Patients may have had prior therapy providing the following conditions are met:

  * Chemotherapy and radiotherapy: wash-out period of 28 days
  * Surgery: wash-out period of 14 days
* Normal cardiac function and absence of uncontrolled hypertension
* Patients must give written informed consent to participate in the study

Exclusion Criteria:

* Concurrent anticancer therapy
* Patients may not receive any other investigational agents while on study
* Clinical signs of CNS involvement
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration