Description:
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.
Title
- Brief Title: Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
- Official Title: A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
Clinical Trial IDs
- ORG STUDY ID:
14-211
- NCT ID:
NCT02308241
Conditions
- Human Papillomavirus (HPV)-Related Malignancies
- Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
Interventions
Drug | Synonyms | Arms |
---|
Ribavirin | | Ribavirin |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Ribavirin | Experimental | 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. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Radiographic responses, determined by RECIST 1.1 criteria |
Time Frame: | 1 year |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | number and grade of toxicities |
Time Frame: | 1 year |
Safety Issue: | |
Description: | will be tabulated using NCI CTCAE version 4, |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- Ribavirin
- Human Papillomavirus (HPV)
- Recurrent/Metastatic (R/M)
- 14-211
Last Updated
May 10, 2021