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A phase I trial of recombinant gamma interferon administered intravenously on a daily x 5 scheduleUniversity of Texas Health Science Center at San Antonio, Texas 78284
Brook Army Medical Center, Ft. Sam Houston, Texas 78234
Brook Army Medical Center, Ft. Sam Houston, Texas 78234
Schering Corporation, Kenilworth, NJ 07033
Schering Corporation, Kenilworth, NJ 07033
University of Texas Health Science Center at San Antonio, Texas 78284
Objective: To determine the maximally tolerated dose and associated toxicity of r- 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- 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.
Journal of Oncology Pharmacy Practice, Vol. 2, No. 1,
22-28 (1996) |
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-IFN. In addition, to evaluate the development of serum IFN neutralizing factors. Design: This is an open-labeled, Phase I dose escalating trial.