Participant flow

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 · Source last updated 2025-04-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO IRX-2: Given via submucosal injection or SC Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

   id

   FG000

   title

   Arm I (IRX-2)

2. description

   Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Placebo: Given via submucosal injections or SC Therapeutic Conventional Surgery: Undergo surgical resection

   id

   FG001

   title

   Arm II (Placebo)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      comment

      Arm I patients CIN3 = 6 VIN3 = 1

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study began recruiting in November 2017 and recruitment ended in August 2023. All participants were seen and treated at USC Norris Comprehensive Cancer Center and/or at LAC+USC Medical Center.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice