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NCT03267680 · OUTCOME

Pathologic Response

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
Week 25

What was measured

Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).

Analysis population: All patients who received at least 1 cycle is included. There is no statistical analysis performed.

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

Pathologic Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (IRX-2)1Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)1Not reportedNot reportedNot reportedNot reported
Persistent CIN3/VIN3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (IRX-2)6Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Pathologic Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    Persistent CIN3/VIN3
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).
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 patients who received at least 1 cycle is included. There is no statistical analysis performed.
reporting Status
POSTED
time Frame
Week 25
title
Pathologic Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice