Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor

• Status: Completed
• Trial end date: 2013-04-01
• 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 cisplatin, 80 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: Cisplatin

Criteria

Inclusion Criteria:

• Patients ≥18 years with advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and suitable for a treatment with cisplatin

• Life expectancy more than 3 months

• ECOG Performance status 0-1

• Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) may represent a risk for the patient

• 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

• Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min

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

• Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days

• Corticosteroid therapy wash out period of 14 days

• Surgery: wash-out period of 14 days

• Patients must give written informed consent to participate in the study

Exclusion Criteria:

• Previous signs of severe toxicity platinum related

• Patients must not receive any other investigational agents while on study

• New York Heart Association class III or IV cardiac disease

• Unstable angina

• Patients with myocardial infarction within the last six (6) months

• Patient with significant peripheral vascular disease

• 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