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Cytokine-based Therapy

Omeprazole for Squamous Cell Carcinoma (INSPIRE Trial)

Phase 2
Waitlist Available
Led By Gregory T Wolf, MD, FACS
Research Sponsored by Brooklyn ImmunoTherapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up until the data cut-off date of june 2, 2022 (approximately 76 months)
Awards & highlights

INSPIRE Trial Summary

This study is evaluating whether a pre-operative regimen of a drug called IRX-2, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and om

Eligible Conditions
  • Squamous Cell Carcinoma

INSPIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up until the data cut-off date of june 2, 2022 (approximately 76 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up until the data cut-off date of june 2, 2022 (approximately 76 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EFS- Time to Event
Event-free Survival (EFS)- Number of Participants With an Event
Secondary outcome measures
OS- Time to Event
Overall Survival (OS)- Number of Participants With an Event

INSPIRE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Regimen 1Experimental Treatment5 Interventions
IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy.
Group II: Regimen 2Active Control4 Interventions
Regimen 1 but without IRX-2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinc-containing multivitamin
2016
Completed Phase 2
~110
Indomethacin
FDA approved
Cyclophosphamide
FDA approved
IRX-2
Not yet FDA approved
Omeprazole
FDA approved

Find a Location

Who is running the clinical trial?

Brooklyn ImmunoTherapeutics, LLCLead Sponsor
7 Previous Clinical Trials
5,375 Total Patients Enrolled
Gregory T Wolf, MD, FACSPrincipal InvestigatorUniversity of Michigan Hospitals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
2016. "IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02609386.
~11 spots leftby Apr 2025
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