Conditions: Cancer
Keywords: NGR-hTNF doxorubicin solid tumors
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 15
Healthy volunteers: no

Brief 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 ).

Detailed description:
This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.

Patients, with advanced or metastatic solid tumor previously treated with a non cumulative dose of doxorubicin (\<300 mg/sqm in order to allow an adequate number of cycles) or chemotherapy naïve will be enrolled.

Arms:
arm 1: None

Interventions: intervention 1: NGR-hTNF intervention 2: Doxorubicin
Intervention descriptions: intervention 1: 0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks intervention 2: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)

Protocol document: