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

NCT00210470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-12-11

Study results available
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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).

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

Sponsors & Collaborators

  • Brooklyn ImmunoTherapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Jeffrey S. Moyer, MD · University of Michigan Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-12-31
Completion
2012-03-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00210470 on ClinicalTrials.gov