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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to assess the safety and efficacy of ruxolitinib in patients with operable Head and neck squamous cell carcinoma (HNSCC) who are planned for definitive surgery.

Official Title

Pharmacodynamic Effects and Predictive Biomarkers of JAK/STAT Inhibition With Ruxolitinib in Operable Head and Neck Cancer: a Window Trial

Details

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).

Keywords

Head and Neck Squamous Cell Carcinoma HNSCC Carcinoma, Squamous Cell Head and Neck Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  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 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 undergo research biopsy prior to receiving drug.
  4. Age ≥ 18 years.
  5. ECOG performance status 0-2 (See Appendix 1).
  6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test(sensitivity ≤ 25IU HCG/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:
  9. Absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 150,000/ul.
  10. Creatinine ≤ 1.5 x institutional upper limit of normal (ULN).
  11. Bilirubin ≤ 1.5 x ULN, AST or ALT ≤ 2.5 x ULN.
  12. Have signed written informed consent

You CAN'T join if...

  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, conivaptam,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.

  1. . Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center not yet accepting patients
    San Francisco, California, 94131, United States
  • University of Arizona Cancer Center not yet accepting patients
    Tucson, Arizona, 85724, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03153982
Phase
Phase 2
Lead Scientist
William Ryan
Study Type
Interventional
Last Updated
November 29, 2017
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