A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

Trial ID or NCT#



not recruiting iconNOT RECRUITING


This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).

Official Title

A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. - No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care. - Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent. - Life Expectancy of greater than 6 months
Exclusion Criteria:
  1. - Stage IVB Squamous Cell Carcinoma - Use of any investigational agent within the previous 30 days - Uncontrolled cardiovascular disease - Myocardial infarction within the last 3 months - Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts - Positive for hepatitis B or C or HIV - Evidence of distant metastases - Clinical gastritis or peptic ulcer within the last 6 months - Stroke within the last six months


Michael J. Kaplan, MD
Edward J. Damrose, MD, FACS
Edward J. Damrose, MD, FACS
Laryngologist, Head and neck surgeon, Ear, nose, and throat specialist, Head and neck oncologist
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Anesthesiology, Perioperative & Pain Medicine
Harlan Pinto
Harlan Pinto
Medical oncologist, Head and neck specialist
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Willard ("Bill") E. Fee, Jr., MD

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Cancer Clinical Trials Office