MedTrace Logo

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

NCT03267680 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-13

Study results available
· View outcomes & findings →

Summary

This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived biologic with multiple active cytokine components, may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.

Conditions

  • Cervical Squamous Cell Carcinoma In Situ
  • Vulvar High Grade Squamous Intraepithelial Lesion

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Indomethacin

Given PO

BIOLOGICAL

IRX-2

Given via submucosal injection or SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DIETARY_SUPPLEMENT

Multivitamin

Given zinc-containing multivitamin PO

DRUG

Omeprazole

Given PO

OTHER

Placebo

Given via submucosal injections or SC

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Brooklyn ImmunoTherapeutics, LLC

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Lynda Roman, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2023-08-04
Completion
2024-03-13
FDA Drug
Yes

Countries

  • United States

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 NCT03267680 on ClinicalTrials.gov