title: Ongoing prospective multicenter safety study of the cytoprotectant amifostine given subcutaneously: overview of trial design.
abstract: The study is a prospective, open-label, multicenter safety study designed to identify treatment-related side effects of amifostine (Ethyol, WR-2721; MedImmune, Inc, Gaithersburg, MD) administered as a subcutaneous injection for the prevention of radiation-induced toxicities. More than 100 patients (68 males, 33 females; median age, 64 years) received 500 mg of amifostine by subcutaneous injection before daily radiation therapy. Four types of targeted adverse events were examined as to their occurrence and possible relationship with amifostine. These adverse events included nausea/vomiting, local skin reactions, skin rashes, and hypotension.
authors.affiliation: Department of Radiation Oncology, Mt. Sinai Medical Center, Miami Beach, FL 33140, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Samuels
authors.forename: Isagani M
authors.initials: IM
authors.lastname: Chico
authors.forename: Robert L
authors.initials: RL
authors.lastname: Hirsch
authors.forename: Keri
authors.initials: K
authors.lastname: Fullmer
mesh_terms: D000368:Aged; D004999:Amifostine / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control; D011837:Radiation-Protective Agents / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D011837:Radiation-Protective Agents; D004999:Amifostine