Status:
COMPLETED
Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Human Papillomavirus (HPV)-Related Malignancies
Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
Eligibility:
All Genders
18+ years
Phase:
NA
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02308241
Start Date
December 2 2014
End Date
March 25 2022
Last Update
January 5 2023
Active Locations (6)
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1
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07939
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
4
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604