NCT00210470 - A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

December 31, 2010

Study Completion Date

March 31, 2012

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

BIOLOGICAL

IRX-2

IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.

DRUG

Cyclophosphamide

Single i.v. injection of low-dose (300 mg/m2) on Day 1

DRUG

Indomethacin

21 days of oral indomethacin, 25 mg. 3 times daily

DRUG

Zinc

21 days of zinc gluconate (65 mg) as part of an oral multivitamin

DRUG

Omeprazole

21 days of 20 mg. orally