Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

Inclusion criteria

• Patient is 18 years of age or older;
• Patient has a histologically documented diagnosis of cancer of the head and neck region;
• Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;

This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:

• Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:

• patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
• with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;

• Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;

• Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.

• The patient or guardian is capable of providing informed consent.

• If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.

Exclusion criteria

• Patient has had previous radiation therapy to the oral mucosa;
• Patient is about to receive hyperfractionated radiation therapy;
• Patient has active oral H. simplex lesions, oral candidiasis, or oral mucositis due to other disease processes;
• Patient has uncontrolled infection;
• Patient has HIV, Hepatitis B (HBV) (as measured by HBs-Ag) or Hepatitis C (HCV) infection;
• Patient has not recovered from oral toxicity attributable to prior treatment;
• Patient has abnormal laboratory values that meet the following criteria:

• Serum creatinine greater than 2 x upper limit of normal
• Total bilirubin greater than 3 x upper limit of normal;
• SGOT greater than 3 x upper limit of normal;
• LDH greater than 3 x upper limit of normal;
• Patient has known sensitivities to any of the study preparation ingredients;
• Patient has participated in a clinical research study within the last 30 days prior to enrollment;
• Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons.