A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
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).
Stanford is currently not accepting patients for this trial.
Brooklyn ImmunoTherapeutics, LLC
- Biological: IRX-2
- Drug: Cyclophosphamide
- Drug: Indomethacin
- Drug: Zinc
- Drug: Omeprazole
- 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
Ages Eligible for Study
18 Years - 80 Years
Genders Eligible for Study