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

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Ribavirin</span> for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

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

    NCT ID: NCT02308241

    ORG ID: 14-211

    Trial Conditions

    Human Papillomavirus (HPV)-Related Malignancies

    Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

    Trial Interventions

    Drug Synonyms Arms
    Ribavirin Ribavirin

    Trial 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.

    Detailed Description

    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. 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Radiographic responses, determined by RECIST 1.1 criteria

    Secondary Outcome Measures

    number and grade of toxicities

    Trial Keywords

    Ribavirin

    Human Papillomavirus (HPV)

    Recurrent/Metastatic (R/M)

    14-211