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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02308241
Collaborator
(none)
12
Enrollment
6
Locations
1
Arm
87.7
Actual Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
Actual Study Start Date :
Dec 2, 2014
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Mar 25, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ribavirin

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)

Outcome Measures

Primary Outcome Measures

  1. Radiographic responses, determined by RECIST 1.1 criteria [1 year]

    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

  1. number and grade of toxicities [1 year]

    will be tabulated using NCI CTCAE version 4,

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Memorial Sloan Kettering Cancer Center at Basking RidgeBasking RidgeNew JerseyUnited States07939
2Memorial Sloan Kettering MonmouthMiddletownNew JerseyUnited States07748
3Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew YorkUnited States11725
4Memorial Sloan Kettering WestchesterHarrisonNew YorkUnited States10604
5Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
6Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew YorkUnited States

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: David Pfister, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02308241
Other Study ID Numbers:
  • 14-211
First Posted:
Dec 4, 2014
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022