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

• Status: Completed
• Trial end date: 2007-05-08
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGC Biologics S.p.A.; MolMed S.p.A.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

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