NCT03267680View on ClinicalTrials.gov

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

PHASE2TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 8, 2017

Primary Completion Date

August 4, 2023

Study Completion Date

March 13, 2024

Conditions
Cervical Squamous Cell Carcinoma In SituVulvar 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

Trial Locations (2)

73104

University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma City

90033

USC / Norris Comprehensive Cancer Center, Los Angeles

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Brooklyn ImmunoTherapeutics, LLC

INDUSTRY

lead

University of Southern California

OTHER