APG-157 for the Treatment of Oral Dysplasia

Inclusion Criteria

• Adult patients age > 18 years with biopsy-proven mild to severe oral or oropharyngeal dysplasia (including CIS) and a visible lesion that have not received treatment or have a new mild-severe dysplasia or CIS following definitive treatment of oral cancer with negative margins. Sites include all oral cavity as well as oropharyngeal dysplasia that is accessible in the outpatient clinic
• Histologically proven oral cavity or oropharyngeal mild or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam
• Measurable disease – minimum lesion size of 8 x 3 mm before initial biopsy (also includes target lesions larger than 8 x 3 mm post-biopsy)
• Willing to provide blood, oral rinse and tissue from diagnostic biopsies
• Leukocytes >= 3,000/microliter. Exception to this inclusion criteria can be made if labs are deemed not clinically significant by the principal investigator (PI)
• Absolute neutrophil count (ct) >= 1,000/microliter. Exceptions to this inclusion criteria can be made if labs are deemed not clinically significant by the PI
• Platelets >= 100,000/microliter. Exceptions to this inclusion criteria can be made if labs are deemed not clinically significant by the PI
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN). Exceptions to this inclusion criteria can be made if labs are deemed not clinically significant by the PI
• Aspartate transferase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT) and serum glutamic pyruvic transferase (SGPT) =< 1.5 x institutional ULN. Exceptions to this inclusion criteria can be made if labs are deemed not clinically significant by the PI
• Willing to use adequate contraception, subject or partner has had a vasectomy or partner is using effective birth control or is post-menopausal for the duration of the study
• Able to take oral medication
• Able to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Pregnant women
• Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions
• Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks
• Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)
• History of prior head and neck squamous cell carcinomas (HNSCC) unless curatively treated 1 year or more prior
• Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and cancer confined to organs with removal as only treatment) in the past 2 years
• Subjects with other related diseases of the oral cavity or oropharynx, as determined to be significant by the PI
• History of allergic reactions attributed to compounds of similar chemical composition to curcumin (turmeric)
• Active or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension. Exceptions to this exclusion criteria can be made if patient status is deemed not clinically significant by the PI
• Severe thrombocytopenia increasing the risk of biopsy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements