Clinical Trials /

Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

NCT02308241

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.

Related Conditions:
  • Anal Carcinoma
  • Cervical Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Oropharyngeal Carcinoma
  • Penile Carcinoma
  • Vaginal Carcinoma
  • Vulvar Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02308241

Trial Eligibility

Document

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

DrugSynonymsArms
RibavirinRibavirin

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

NameTypeDescriptionInterventions
RibavirinExperimentalStudy 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.
  • Ribavirin

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