IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
Public ClinicalTrials.gov record NCT02609386. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02609386
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Interventions
- IRX-2 Biological
- Cyclophosphamide Drug
- Indomethacin Drug
- Zinc-containing multivitamin Dietary Supplement
- Omeprazole Drug
Biological · Drug · Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2016 (Actual)
- Primary completion
- Feb 28, 2022 (Actual)
- Completion
- Feb 28, 2022 (Actual)
- Last update posted
- Jan 30, 2024
2016 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85742 | — |
| University of Arkansas For Medical Sciences | Little Rock | Arkansas | 72205 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Emory University - Winship Cancer Center | Atlanta | Georgia | 30322 | — |
| University of Kentucky | Lexington | Kentucky | 40506 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Monter Cancer Center - North Shore LIJ | New Hyde Park | New York | 11040 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
| Providence Cancer Center | Portland | Oregon | 97209 | — |
| Hospital of The University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02609386, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02609386 live on ClinicalTrials.gov.