Protocol
10-218
Full Title
A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients with Tonsil and/or Base of Tongue Squamous Cell Carcinoma
Purpose
Although human papillomavirus (HPV-16) is not thought to cause cancer by itself, it appears to contribute to the development of tonsil cancer in many patients. It is likely that treatment for many patients with tonsil cancer could be improved if effective therapy to control HPV-16 is developed.
The investigators in this study want to learn if the drug ribavirin is active against HPV-16. Ribavirin is a pill approved as part of the standard treatment for hepatitis C. Laboratory studies suggest that ribavirin might also be useful in the treatment of head and neck cancers, but it has not yet been evaluated in these patients.
The purpose of this study is to examine the effects of ribavirin on tonsil squamous cell cancer when it is given before surgery. Researchers want to see if ribavirin changes the expression of certain proteins related to HPV infection in the tumor. They will also determine if ribavirin changes how the tumor appears on a PET/CT scan (positron emission tomography/computed tomography scan).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have confirmed diagnosis of squamous cell carcinoma of the tonsils that tests positive for the p16 and phosphorylated eIF4E proteins and will be surgically removed.
- Patients may not have had prior chemotherapy or radiation therapy for tonsil cancer.
- Patients may not have a smoking history of more than 10 pack-years.
- Patients may not have hepatitis B or C.
- Patients must be at least age 18 but younger than 60.
For more information about this study and to inquire about eligibility, please contact Dr. Matthew G. Fury at 646-888-4233.
Disease(s)
Head & Neck Cancer
Locations
ClinicalTrials.gov
Related Diseases
