Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/31/2018 |
| Start Date: | December 2010 |
| End Date: | December 2019 |
A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma
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).
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).
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:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥
160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within 1.5 X upper limit of
normal (ULN) ; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine
transaminase (ALT) ≤ 2.5 X ULN (Patients with Gilbert's syndrome as the cause of
hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL) 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.
- 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
- History of unstable angina or myocardial infarction (MI) within the last 3 years
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