An interventional study of Ribavirin in Human Papillomavirus (HPV)-Related Malignancies and Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Drug: Ribavirin
self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
Radiographic Responses, Determined by RECIST 1.1 Criteria
will be tabulated by adding partial responses and complete responses (CR + PR). The regimen would be considered worthy of further study if radiographic responses are observed in at least 2 of 12 subjects.
Time frame: 1 year
Number of Participants Evaluated for Toxicity
will be tabulated using NCI CTCAE version 4,
Time frame: 1 year
| Milestone | Ribavirin |
|---|---|
| Started | 12 |
| Completed | 9 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
will be tabulated by adding partial responses and complete responses (CR + PR). The regimen would be considered worthy of further study if radiographic responses are observed in at least 2 of 12 subjects.
| Participants | Ribavirin |
|---|---|
| Stable Disease | 5 |
| Progression of Disease | 4 |
| Unevaluable | 3 |
will be tabulated using NCI CTCAE version 4,
| Participants | Ribavirin |
|---|---|
| Number of Participants Evaluated for Toxicity | 12 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ribavirin | 12/12 (100%) | 3/12 (25%) | 12/12 (100%) |
| Event | Ribavirin |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 1/12 |
| Blood bilirubin increasedInvestigations | 1/12 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/12 |
| FeverGeneral disorders | 1/12 |
| SyncopeNervous system disorders | 1/12 |
| Event | Ribavirin |
|---|---|
| AnemiaBlood and lymphatic system disorders | 12/12 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 6/12 |
| Blood bilirubin increasedInvestigations | 5/12 |
| AnorexiaMetabolism and nutrition disorders | 4/12 |
| Aspartate aminotransferase increasedInvestigations | 4/12 |
| Lymphocyte count decreasedInvestigations | 4/12 |
| FeverGeneral disorders | 3/12 |
| White blood cell decreasedInvestigations | 3/12 |
| Alkaline phosphatase increasedInvestigations | 2/12 |
| ConstipationGastrointestinal disorders | 2/12 |
| Age, Continuous(years) | Ribavirin |
|---|---|
| Median | 59 (47 to 69) |
| Sex: Female, Male(Participants) | Ribavirin |
|---|---|
| Female | 4 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Ribavirin |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 7 |
| Race (NIH/OMB)(Participants) | Ribavirin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Ribavirin |
|---|---|
| United States | 12 |
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Memorial Sloan Kettering Cancer Center