Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer

Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT

The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.

Inclusion Criteria:

• Pathologically confirmed squamous cell cancer of the head and neck
• Eligible sites: oral cavity, oropharynx, hypopharynx, larynx.
• Patients requiring postoperative IMRT.
• KPS > 70%.
• Patient has signed specific protocol consent prior to registration.
• Calcium test within normal limits.
• No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years.
• Labs completed with 30 days of registration (CBC & platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation.
• Liver CT if alk phos, SGOT, or bili elevated.
• Bone scan if elevated alk phos

Exclusion Criteria:

• Metastatic disease.
• Patient using Salagen or concurrent chemotherapy.
• Previous XRT for head and neck tumors.
• Active untreated infection.