Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM

Inclusion Criteria

• •Age ≥ 18 years
• •Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
• •Patients with non-progressive disease after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease
• •ECOG Performance Status 0 - 1
• •Life expectancy of ≥ 12 weeks
• •Adequate baseline bone marrow, hepatic and renal function, defined as follows:
• •1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x109/L; hemoglobin ≥ 9 g/dL
• •2. Bilirubin ≤ 1.5 x ULN
• •3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
• •4. Serum creatinine \< 1.5 x ULN
• •Measurable or non-measurable disease according to malignant pleural mesothelioma-modified RECIST criteria
• •Patients may have had prior therapy providing the following conditions are met:
• •* Surgery: wash-out period of 14 days
• •* Radiation therapy: wash-out period of 28 days
• •* Chemotherapy: wash-out period of 21 days
• •Patients must give written informed consent to participate in the study