The purpose of this study is to find out the effects, both good and bad, that a drug called
ribavirin has on the patient and the cancer.
Ribavirin has also been studied in clinical trials for patients with various types of
cancer. These studies demonstrated that ribavirin can be safely given at higher doses than
the dosing that is used as part of the treatment of hepatitis C.
Ribavirin is known to target a protein called "4E" that turns on a central part which causes
the cell to grow, called the ribosome. HPV-related cancers often have abnormally high levels
of 4E. The purpose of this study is to evaluate if ribavirin may be a useful treatment for
patients with advanced cancers that are related to HPV by blocking the activity of 4E.
- Recurrent and/or metastatic HPV-related carcinoma of the cervix, anus, vagina, vulva,
penis, or oropharynx. The cancer diagnosis must be confirmed by slide review in the
MSKCC Department of Pathology. HPV positive status must be demonstrated by HPV in
situ-hybridization (ISH) and/or by p16 immunohistochemistry (IHC).
Note: For cervix squamous cancer, HPV ISH test or p16 IHC test is not required, because
all cervix squamous cancers are presumed to be HPV-associated.
- Adults ( 18 years of age)
- ECOG performance status of 1 or better
- Measurable disease according to RECIST 1.1 criteria
- Availability of archived tumor tissue for correlative studies (5 unstained slides)
- Adequate organ function, as follows:
- Adequate bone marrow reserve: absolute neutrophil count (ANC) 1.5 X 109/L,
platelets 160 X 109/L, hemoglobin 10 g/dL
- Hepatic: total bilirubin within ULN (upper limit of normal); alkaline phosphatase
(AP), aspartate transaminase (AST) and alanine transaminase (ALT) 2.0 X ULN
- Renal: Serum creatinine 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may
be eligible if creatinine clearance (CrCl) 55 mL/min based on the standard Cockroft
and Gault formula.
- Ability to swallow oral medication.
- 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.
- At least one prior systemic therapy regimen for R/M HPV-related carcinoma
- History of hemolytic anemia or thalassemia
- Current treatment or known prior treatment with ribavirin
- Active infection or serious underlying medical condition that would impair the
patient's ability to receive protocol treatment.
- Current therapeutic anticoagulation with Coumadin (warfarin)
- Known brain metastases
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both