Ongoing prospective multicenter safety study of the cytoprotectant amifostine given subcutaneously: overview of trial design.
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.
Samuels
Michael A
MA
Department of Radiation Oncology, Mt. Sinai Medical Center, Miami Beach, FL 33140, USA.
Chico
Isagani M
IM
Hirsch
Robert L
RL
Fullmer
Keri
K
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
D011837:Radiation-Protective Agents; D004999:Amifostine