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NCT03267680 · OUTCOME

Incidence of Adverse Events of IRX-2 Administration

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 months

What was measured

Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.

Analysis population: All treated patients are included

Groups in this outcome

Arm I (IRX-2)

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

Arm II (Placebo)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (IRX-2)7
Arm II (Placebo)3

Reported measurements

Grades 1 and 2 Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (IRX-2)7Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)3Not reportedNot reportedNot reportedNot reported
Grades 3 and 4 Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (IRX-2)0Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        3
    title
    Grades 1 and 2 Adverse Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grades 3 and 4 Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.
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
    OG000
    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
    OG001
    title
    Arm II (Placebo)
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated patients are included
reporting Status
POSTED
time Frame
Up to 30 months
title
Incidence of Adverse Events of IRX-2 Administration
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice