Patients will take ruxolitinib twice daily during the pre-operative window for 14-21 days, or
up to 28 days for delays in planned surgery. Ruxolitinib will be dispensed in 5 mg tablets.
Participants will either take three tablets (15 mg) in the morning and evening, or four
tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug
diary indicating when doses of study drug are taken and any side effects they experience.
Dose will be assigned based on participant platelet count at baseline:
1. Patients with a platelet count of 200,000 or greater will take 20 mg twice daily (four
5mg tablets in the morning and four 5mg tablets in the evening);
2. Patients with a platelet count between150,000 and 200,000 will take 15 mg twice daily
(three 5 mg tablets in the morning and three 5 mg tablets in the evening).
Inclusion Criteria:
1. Histologically or cytologically confirmed, primary or recurrent, head and neck
squamous cell carcinoma, including variants. Patients must have at least one
measureable lesion in accordance with RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis
lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm). Any
diagnostic pretreatment biopsy sample is acceptable including fine needle aspiration
(FNA).
2. Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx)
site will be included.
3. Surgical resection of head and neck must be planned, either as primary treatment or
salvage. Patients must have submitted adequate pretreatment archival or fresh tissue.
4. Age ≥ 18 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix 1).
6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
(sensitivity ≤ 25 human chorionic gonadotropin (HCG) IU/L) within 4 weeks prior to
registration and will be repeated within 72 hours prior to the start of study drug
administration.
7. Persons of reproductive potential must agree to use and utilize an adequate method of
contraception throughout treatment and for at least 12 weeks after study drug is
stopped. Prior to study enrollment, women of childbearing potential must be advised of
the importance of avoiding pregnancy during trial participation and the potential risk
factors for an unintentional pregnancy.
8. Adequate hematologic, renal and hepatic function, as defined by:
1. Absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 150,000/ul.
2. Creatinine ≤ 1.5 x institutional upper limit of normal (ULN).
3. Bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) ≤ 2.5 x ULN.
9. Have signed written informed consent
Exclusion Criteria:
1. Subjects who fail to meet the above criteria.
2. Prior therapy for head and neck cancer is allowed, and the number of treatments is not
limited. However, any systemic therapy should have been completed at least 30 days
prior to study enrollment. Any radiation to the head and neck should have been
completed at least 30 days prior to study enrollment. Palliative radiation outside of
the head and neck does not require a washout.
3. Pregnancy or breastfeeding. Women (patients or partners of male patients) of
childbearing potential (WOCBP) must practice acceptable methods of birth control to
prevent pregnancy. All WOCBP must have a negative pregnancy test within 4 weeks prior
to registration, and this must be repeated within 72 hours prior to first receiving
ruxolitinib. If the pregnancy test is positive, the patient must not receive
ruxolitinib and must not be enrolled in the study.
4. Any unresolved chronic toxicity ≥ grade 2 from previous anticancer therapy (except
alopecia and anemia), according to Common Terminology Criteria for Adverse Events v4.0
(CTCAE).
5. Current active infection requiring systemic antibiotic or antifungal therapy.
6. Acute hepatitis or known HIV.
7. Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of
study treatment.
8. New York Heart Association (NYHA) Class III or IV heart disease.
9. History of thromboembolic event or other condition currently requiring anticoagulation
with warfarin (coumadin). Patients who are treated with low molecular weight heparin
or fondaparinux are eligible.
10. History of significant bleeding disorder unrelated to cancer, including: diagnosed
congenital bleeding disorders (e.g., von Willebrand's disease, diagnosed acquired
bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies, or
ongoing or recent (≤ 3 months) significant gastrointestinal bleeding
11. Concomitant Medications, any of the following should be considered for exclusion:
Strong CYP3A4 inhibitors: (Patients must discontinue drug 7 days prior to starting
ruxolitinib), including but not limited to boceprevir, clarithromycin, conivaptan,
indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, nefazodone, nelfinavir,
posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole. In
addition, patients will be instructed to avoid grapefruit or grapefruit juice,
starfruit, or seville oranges.
12. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious) illness.
