Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:5/9/2018
Start Date:December 2, 2014
End Date:December 2019

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A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
6
sites
1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Phone: 646-888-4232
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Rockville Centre, NY
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Phone: 646-888-4232
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Basking Ridge, NJ
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Commack, New York 11725
Phone: 646-888-4232
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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Middletown, New Jersey 07748
Phone: 646-888-4232
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Middletown, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: David Pfister, MD
Phone: 646-888-4232
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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