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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brooklyn ImmunoTherapeutics, LLC; IRX Therapeutics
• Treatments: Cyclophosphamide; Indomethacin; Omeprazole; Zinc

Criteria

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