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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
Purpose
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
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Edward J. Damrose, MD, FACS
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Anesthesiology, Perioperative & Pain Medicine
Eligibility
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
Intervention(s):
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
650-498-7061