Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02308241|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : May 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus (HPV)-Related Malignancies Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies||Drug: Ribavirin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies|
|Actual Study Start Date :||December 2, 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
- Radiographic responses, determined by RECIST 1.1 criteria [ Time Frame: 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.
- number and grade of toxicities [ Time Frame: 1 year ]will be tabulated using NCI CTCAE version 4,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308241
|United States, New Jersey|
|Memorial Sloan Kettering Cancer Center at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07939|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Principal Investigator:||David Pfister, MD||Memorial Sloan Kettering Cancer Center|