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IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

NCT02609386 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-01-30

Study results available
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Summary

The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.

Conditions

  • Squamous Cell Carcinoma of the Oral Cavity

Interventions

BIOLOGICAL

IRX-2

Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.

DRUG

Cyclophosphamide

Method of Administration: Cyclophosphamide is administered once by IV

DRUG

Indomethacin

Method of Administration: Indomethacin is administered orally for 21 days.

DIETARY_SUPPLEMENT

Zinc-containing multivitamin

Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.

DRUG

Omeprazole

Method of Administration: Omeprazole is administered orally for 21 days

Sponsors & Collaborators

  • Brooklyn ImmunoTherapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Gregory T Wolf, MD, FACS · University of Michigan Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-11
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United States
  • Brazil
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02609386 on ClinicalTrials.gov