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Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma | Clinical Trials | Clareo Health

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Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma

A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma

NCT01268579•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in many patients. It is likely that treatment for many patients with tonsil and/or base of tongue cancer could be improved if effective therapy to control HPV-16 is developed. The investigators in this study want to learn if ribavirin shows evidence of activity against HPV-16. Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin might also be useful in the treatment of head and neck cancers. However, ribavirin has not yet been tested against head and neck cancer in patients. The purpose of this study is to find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients. The main purpose of this study is to see if ribavirin changes the expression of certain proteins related to HPV infection in the tumor. The study will also find out if ribavirin changes how the tumor appears in a PET/CT scan (positron emission tomography/computed tomography scan).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Prior diagnostic surgical or core needle biopsy, with confirmation of tonsil and/or base of tongue squamous cell carcinoma that is positive for expression of p16 and phosphorylated eIF4E, as determined by the Department of Pathology at MSKCC. The biopsy may be either of the tonsil base of tongue and/or an involved neck node. 2 unstained slides and/or tissue block must be available from the initial diagnostic biopsy
•Positive expression p16 and phosphorylated eIF4E is defined as \>=30% of tumor cells with cytological and/or nuclear staining
•Age ≥ 18 and ≤ 65 years of age
•Karnofsky Performance Status ≥ 80
•Adequate organ function, as follows:
•Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
•Ability to swallow oral medication.
•Non-surgical patients: If primary radiation +/- chemotherapy (concurrent or sequential) is planned, patients must agree to undergo research biopsy after completion of ribavirin treatment.

Exclusion Criteria

•Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer
•More than 10 pack-years of tobacco use
•History of hemolytic anemia or thalassemia
•Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
•Current therapeutic anticoagulation with Coumadin (warfarin)
•Current or prior treatment with ribavirin
•Known active Hepatitis B or C
•Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
•New York Heart Association (NYHA) Grade II or greater congestive heart failure
•Clinically significant peripheral vascular disease
+1 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

December 28, 2010

Primary Completion Date

October 31, 2022

Completion Date

October 31, 2022

Last Updated

October 2, 2023

Enrollment

ACTUAL participants

Conditions

HEAD & NECK Cancer

Interventions

ribavirin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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