CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
IRX-2 +4 morebiological
Likely dose
IRX-2: 2 mL (1 mL × 2 injections) subcutaneously daily for 10 days into bilateral mastoid insertion regions; Cyclophosphamide: 300 mg/m² intravenous single injection on Day 1; Indomethacin: 25 mg orally three times daily for 21 days; Zinc gluconate: 65 mg daily for 21 daysAI-extracted
Key inclusion· 4
  • ✓Pathologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
  • ✓No prior surgery, radiation, or chemotherapy for this tumor (except biopsy or emergency supportive care procedures)
  • ✓Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent
  • ✓Life expectancy greater than 6 months
Key exclusion· 9
  • ✕Stage IVB squamous cell carcinoma
  • ✕Use of any investigational agent within 30 days prior to enrollment
  • ✕Uncontrolled cardiovascular disease
  • ✕Myocardial infarction within last 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00210470
NCT00210470Phase 2Completed
CompareCT.gov

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

Brooklyn ImmunoTherapeutics, LLC·interventional·Posted Sep 21, 2005·Updated Dec 11, 2020

In Brief

A Phase 2 clinical trial evaluating IRX-2, Cyclophosphamide, and 3 other interventions for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 27 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartJul 1, 2005
Primary CompletionDec 1, 2010
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 20.8 years ago

Interventions

IRX-2biological

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

Cyclophosphamidedrug

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

Indomethacindrug

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

Zincdrug

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

Omeprazoledrug

21 days of 20 mg. orally