An interventional study of ribavirin in HEAD & NECK Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
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).
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
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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.
Exclusion Criteria:
This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
Drug: ribavirin
The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
of phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.
Time frame: 2 weeks
to Explore the Pharmacodynamic Effects of Ribavirin
on molecules that may be regulated directly or indirectly by eIF4E (eg, p16, p21, EGFR, p53).). Immunohistochemistry will be performed on Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery),to describe the effects of ribavirin treatment on the expression of phosphorylated eIF4E.
Time frame: pre-treatment and post treatment
To Explore if Ribavirin Reduces the Expression of HPV-16 Oncoproteins E6 and E7
Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery)
Time frame: In pre- and post-treatment tumor samples
| Milestone | Ribavirin |
|---|---|
| Started | 9 |
| Completed | 6 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
of phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.
| Participants | Ribavirin |
|---|---|
| Decreased p-eIF4E after 14 days of ribavirin | 4 |
| No decreased p-eIF4E after 14 days of ribavirin | 2 |
| Not evaluable | 3 |
on molecules that may be regulated directly or indirectly by eIF4E (eg, p16, p21, EGFR, p53).). Immunohistochemistry will be performed on Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery),to describe the effects of ribavirin treatment on the expression of phosphorylated eIF4E.
No measurements were reported for this outcome.
Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery)
No measurements were reported for this outcome.
Collected over Up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ribavirin | 8/9 (88.9%) | 0/9 (0%) | 9/9 (100%) |
| Event | Ribavirin |
|---|---|
| AnemiaBlood and lymphatic system disorders | 6/9 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 5/9 |
| Blood bilirubin increaseInvestigations | 3/9 |
| FatigueGeneral disorders | 3/9 |
| AnorexiaMetabolism and nutrition disorders | 2/9 |
| Aspartate aminotransferase increaseInvestigations | 2/9 |
| FeverGeneral disorders | 2/9 |
| Gastroesophageal RefluxGastrointestinal disorders | 2/9 |
| Weight lossInvestigations | 2/9 |
| Alanine aminotransferase increaseInvestigations | 1/9 |
| Age, Continuous(years) | Ribavirin |
|---|---|
| Median | 59 (47 to 69) |
| Sex: Female, Male(Participants) | Ribavirin |
|---|---|
| Female | 2 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Ribavirin |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Ribavirin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | Ribavirin |
|---|---|
| United States | 9 |
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Memorial Sloan Kettering Cancer Center