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)

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

Harlan Pinto
Harlan Pinto

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

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

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