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A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma


N/A
18 Years
65 Years
Open (Enrolling)
Both
HEAD & NECK Cancer

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Trial Information

A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma


Inclusion Criteria:



- Prior diagnostic surgical or core needle biopsy, with confirmation of tonsil and/or
base of tongue squamous cell carcinoma that is positive for expression of p16 and
phosphorylated eIF4E, as determined by the Department of Pathology at MSKCC. The
biopsy may be either of the tonsil base of tongue and/or an involved neck node. 2
unstained slides and/or tissue block must be available from the initial diagnostic
biopsy

- Positive expression p16 and phosphorylated eIF4E is defined as >=30% of tumor cells
with cytological and/or nuclear staining

- Age ≥ 18 and ≤ 65 years of age

- Karnofsky Performance Status ≥ 80

- Adequate organ function, as follows:

Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥
160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within 1.5 X upper limit of
normal (ULN) ; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine
transaminase (ALT) ≤ 2.5 X ULN (Patients with Gilbert's syndrome as the cause of
hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL) 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.

- 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.

- Ability to swallow oral medication.

- Non-surgical patients: If primary radiation +/- chemotherapy (concurrent or
sequential) is planned, patients must agree to undergo research biopsy after
completion of ribavirin treatment.

Exclusion Criteria:

- Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer

- More than 10 pack-years of tobacco use

- History of hemolytic anemia or thalassemia

- Active infection or serious underlying medical condition that would impair the
patient's ability to receive protocol treatment.

- Current therapeutic anticoagulation with Coumadin (warfarin)

- Current or prior treatment with ribavirin

- Known active Hepatitis B or C

- Any prior documented history of transient ischemic attack (TIA) or cerebrovascular
accident (CVA)

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Clinically significant peripheral vascular disease

- History of unstable angina or myocardial infarction (MI) within the last 3 years

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To explore if ribavirin therapy for 2 weeks decreases tumor expression

Outcome Description:

of phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.

Outcome Time Frame:

2 weeks

Safety Issue:

No

Principal Investigator

Matthew Fury, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-218

NCT ID:

NCT01268579

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Head & Neck Cancer
  • ribavirin
  • VIRAZOLE
  • tonsil
  • base of tongue
  • squamous cell carcinoma
  • 10-218
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Tongue Neoplasms
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021