Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.

Inclusion Criteria: * Patients ≥ 18 years * Histologically-proven, locally advanced, or metastatic STS (excluding extraosseus Ewing sarcoma) * Patients not amenable to surgery, radiotherapy, or combined-modality therapy with curative intent * Patients untreated or previously treated with one or more systemic regimen * ECOG Performance status 0-2 (Appendix A) * At least one untreated (not previously irradiated) target lesion that could be measured in one dimension, according to RECIST criteria * A life expectancy of 12 weeks or more * Adequate baseline bone marrow, hepatic and renal function, defined as follows: * Neutrophils \> 1.5 x 109/L and platelets \> 100 x 109/L * Bilirubin \< 1.5 x ULN * AST and/or ALT \< 2.5 x ULN in absence of liver metastasis or \< 5 x ULN in presence of liver metastasis * Serum creatinine \< 1.5 x ULN * Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min * Patients may have had prior treatment providing the following conditions are met before treatment start: * Surgery and radiation therapy: wash-out period of 14 days * Systemic therapy: wash-out period of 21 days * Patients must give written informed consent Exclusion Criteria: * Patients may not receive any other investigational agents while on study * Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * LVEF \< 55% (only for patients candidate for doxorubicin treatment) * Uncontrolled hypertension * Prolonged QTc interval (congenital or acquired) \> 450 ms * History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy) or history of stroke * 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 or contraindications 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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration