Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors

Inclusion Criteria:

• Patients ≥18 years old with proven advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and previously treated with a non cumulative dose of anthracyclines (<300 mg/sqm) or chemotherapy naïve.
• Life expectancy more than 3 months.
• ECOG performance status 0 - 2.
• Normal cardiac function (left ventricular ejection fraction [LVEF] ≥55%) and absence of uncontrolled hypertension.
• Absence of any conditions involving hypervolemia and its consequences.
• 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 x ULN Serum creatinine < 1.5 x ULN

• Patients may have had prior therapy providing the following conditions are met:

  • Chemo, radio, hormonal, immuno or anti-vascular therapy: wash-out period of 28 days.
  • Surgery: wash-out period of 14 days.
• Patients must give written informed consent to participate in the study.

Exclusion Criteria:

• Concurrent anticancer therapy
• Patients must not receive any other investigational agents while on study
• Patients with a LVEF <55%
• New York Heart Association class III or IV cardiac disease
• Acute angina
• Patients with myocardial infarction within the last six (6) months
• Patient with significant peripheral vascular disease
• Thrombosis of main portal vein
• Previous signs of severe toxicity doxorubicin related
• Previous signs of cardiotoxicity doxorubicin related
• Patients previously treated with a cumulative dosage of anthracyclines ≥300 mg/m^2
• 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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration