Trial Outcomes & Findings for IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 (NCT NCT03267680)
NCT ID: NCT03267680
Last Updated: 2025-04-13
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Week 25
Results posted on
2025-04-13
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
Baseline characteristics by cohort
| Measure |
Arm I (IRX-2)
n=7 Participants
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)
n=3 Participants
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
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Smoking Status
Never Smoke
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Smoking Status
Former Smoker
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Smoking Status
Current Smoker
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Alcohol Use
Yes
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Alcohol Use
No
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
HPV Status (High Risk Positive)
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ever Received HPV Vaccine
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ever Received HPV Vaccine
No
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ever Received HPV Vaccine
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Menopausal Status
Premenopausal
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Menopausal Status
Postmenopausal
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Menopausal Status
Surgical/Other for Amenorrhea
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of Pregancies
0
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Pregancies
1 or 2
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of Pregancies
2 or more
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Abortions/Miscarriages
0
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Number of Abortions/Miscarriages
1
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Still Births
0
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Number of Still Births
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of Live Births
0
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of Live Births
1 or 2
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Live Births
2 or more
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of Live Births
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Currently Sexually Active
No
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Currently Sexually Active
Yes
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Currently Sexually Active
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of Lifetime Partners
1 or 2
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of Lifetime Partners
2 or more
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Lifetime Partners
Unknown
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Contraception Use
No
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Contraception Use
Yes
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 25Population: All patients who received at least 1 cycle is included. There is no statistical analysis performed.
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).
Outcome measures
| Measure |
Arm I (IRX-2)
n=7 Participants
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)
n=3 Participants
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
|
|---|---|---|
|
Pathologic Response
Pathologic Complete Response
|
1 Participants
|
1 Participants
|
|
Pathologic Response
Persistent CIN3/VIN3
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: All treated patients are included
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.
Outcome measures
| Measure |
Arm I (IRX-2)
n=7 Participants
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)
n=3 Participants
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
|
|---|---|---|
|
Incidence of Adverse Events of IRX-2 Administration
Grades 1 and 2 Adverse Events
|
7 Participants
|
3 Participants
|
|
Incidence of Adverse Events of IRX-2 Administration
Grades 3 and 4 Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Arm I (IRX-2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (IRX-2)
n=7 participants at risk
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)
n=3 participants at risk
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
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
57.1%
4/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Gastrointestinal disorders
Mucositis Oral
|
28.6%
2/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • 30 months
|
66.7%
2/3 • 30 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
General disorders
Chills
|
14.3%
1/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
General disorders
Fatigue
|
85.7%
6/7 • 30 months
|
66.7%
2/3 • 30 months
|
|
General disorders
Injection Site Reaction
|
28.6%
2/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
General disorders
Pain
|
0.00%
0/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Investigations
Neutrophil Count Decreased
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
3/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Reproductive system and breast disorders
Vaginal Pain
|
28.6%
2/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/7 • 30 months
|
66.7%
2/3 • 30 months
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/7 • 30 months
|
33.3%
1/3 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Skin and subcutaneous tissue disorders
Burning in Clitoris
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • 30 months
|
0.00%
0/3 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
28.6%
2/7 • 30 months
|
0.00%
0/3 • 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place