A phase i trial of recombinant gamma interferon administered intravenously on a daily X 5 schedule

Objective: To determine the maximally tolerated dose and associated toxicity of r-γ-IFN. In addition, to evaluate the development of serum IFN neutralizing factors. Design: This is an open-labeled, Phase I dose escalating trial.Setting: This trial was carried out at a Veteran's Administration and Army hospital.Patients: Patients with advanced malignancies for whom no known effective therapy is available were eligible. Patients must have adequate organ function, a performance status of 2 or lower and a minimal life expectancy of 2 months.Intervention: Patients received escalating doses of r-γ-IFN (0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 10.0 X 106 IU/m2) daily for 5 days given intravenously over 2 hours every other week.Main Outcome Measures: Tumor response was followed clinically, with radiographic support when appropriate. Toxicity was evaluated using the World Health Organization (WHO) standard toxicity grading guidelines. Serum samples were used to monitor and evaluate the IFN neutralizing factors.