Human Papillomavirus (HPV)-Related Malignancies Clinical Trial
Official title:
A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
| NCT number | NCT02308241 |
| Other study ID # | 14-211 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2, 2014 |
| Est. completion date | March 25, 2022 |
| Verified date | March 2022 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 25, 2022 |
| Est. primary completion date | March 25, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center @ Suffolk | Commack | New York |
| United States | Memorial Sloan Kettering Westchester | Harrison | New York |
| United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1 year | |
| Secondary | Number of Participants Evaluated for Toxicity | will be tabulated using NCI CTCAE version 4, | 1 year |