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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Papillomavirus (HPV)-Related Malignancies; Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

Intervention: Ribavirin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
David Pfister, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
David Pfister, MD, Phone: 646-888-4232

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.

Clinical Details

Official title: A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Radiographic responses, determined by RECIST 1.1 criteria

Secondary outcome: number and grade of toxicities

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

David Pfister, MD, Phone: 646-888-4232

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey 07939, United States; Recruiting
David Pfister, MD, Phone: 646-888-4232

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States; Recruiting
David Pfister, MD, Phone: 646-888-4232

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
David Pfister, MD, Phone: 646-888-4232
Shrujal Baxi, MD, Phone: 646-888-4236
David Pfister, MD, Principal Investigator

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States; Recruiting
David Pfister, MD, Phone: 646-888-4232

Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York 10591, United States; Recruiting
David Pfister, MD, Phone: 646-888-4232

Memorial Sloan Kettering West Harrison, West Harrison, New York 10604, United States; Recruiting
David Pfister, MD, Phone: 646-888-4232

Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: December 2014
Last updated: July 17, 2015

Page last updated: August 23, 2015

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