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#
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).
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
- - 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
- - 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
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Cancer Clinical Trials Office