A phase I trial of recombinant gamma interferon administered intravenously on a daily × 5 schedule

Autor:	Kenneth Beougher, Eric M. Bonnem, Daniel D. VonHoff, Jim M. Koeller, James P. Golando, T. D. Brown
Rok vydání:	1996
Předmět:	medicine.medical_specialty Performance status business.industry Organ function Serum samples Tumor response World health law.invention Oncology law Internal medicine Gamma interferon Toxicity medicine Recombinant DNA Pharmacology (medical) business
Zdroj:	Journal of Oncology Pharmacy Practice. 2:22-28
ISSN:	1477-092X 1078-1552
Popis:	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 106IU/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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::8dad23f5d682f1dc967085ee08b31d30 https://doi.org/10.1177/107815529600200103 Zobrazit plný text záznamu