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

Not Recruiting

Trial ID: NCT00210470


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

Stanford Investigator(s)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Edward J. Damrose, MD, FACS
Edward J. Damrose, MD, FACS

Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Anesthesiology, Perioperative & Pain Medicine


Inclusion Criteria:

   - 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:

   - 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


drug: Cyclophosphamide

drug: Indomethacin

drug: Zinc

drug: Omeprazole

biological: IRX-2

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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