Your session is about to expire
← Back to Search
Immunotherapy
IRX-2 Regimen for Cervical Carcinoma
Phase 2
Waitlist Available
Led By Lynda Roman, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed squamous CIN 3, or VIN 3 (usual type only)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 25
Awards & highlights
Study Summary
This trial is testing a new cancer treatment consisting of a single dose of a chemotherapy drug, followed by 21 days of taking a combination of vitamins, minerals, and a common stomach ulcer medication. The new treatment also includes a drug that may help boost the immune system.
Who is the study for?
Women with confirmed cervical or vulvar pre-cancerous lesions (CIN 3 or VIN 3) can join. They must have normal blood counts, liver and kidney function, understand the study and consent to it, be able to follow up regularly, use effective birth control if of childbearing potential (excluding cervical caps/diaphragms for those with CIN 3), and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the IRX-2 Regimen on women with certain pre-cancerous conditions of the cervix or vulva. This regimen includes cyclophosphamide followed by a combination of indomethacin, zinc-containing multivitamins, omeprazole for 21 days, plus IRX-2 injections which may boost immune response against these lesions.See study design
What are the potential side effects?
Possible side effects include reactions related to immune stimulation such as inflammation in various organs. Cyclophosphamide might cause nausea or hair loss; indomethacin could lead to stomach issues; omeprazole generally has fewer side effects but may cause digestive discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is either CIN 3 or VIN 3 (usual type).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 25
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic response
Secondary outcome measures
Incidence of adverse events of IRX-2 administration
Side effects data
From 2012 Phase 2 trial • 27 Patients • NCT0021047030%
HEADACHE
22%
INJECTION SITE PAIN
22%
NAUSEA
15%
CONSTIPATION
15%
DIZZINESS
11%
ASPIRATION PNEUMONIA
11%
FATIGUE
11%
PNEUMONIA ASPIRATION
11%
ANAEMIA
7%
MYALGIA
7%
CONTUSION
7%
INJECTION SITE DISCOMFORT
7%
DRY MOUTH
7%
VOMITING
4%
POSTOPERATIVE INFECTION
4%
RESPIRATORY INFECTION
4%
NECK ABSCESS
4%
ALCOHOL WITHDRAWAL
100%
80%
60%
40%
20%
0%
Study treatment Arm
IRX-2 Regimen
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (IRX-2)Experimental Treatment7 Interventions
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.
Group II: Arm II (placebo)Active Control7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omeprazole
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Cyclophosphamide
FDA approved
Indomethacin
FDA approved
IRX-2
Not yet FDA approved
Multivitamin
2016
Completed Phase 4
~20750
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,267 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,656 Total Patients Enrolled
Brooklyn ImmunoTherapeutics, LLCIndustry Sponsor
7 Previous Clinical Trials
5,469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My total bilirubin levels are less than twice the upper limit, except if due to Gilbert's disease.I have not donated or lost more than 450 mL of blood in the last month.I am allergic to ciprofloxacin or similar antibiotics.I have not used Aldara for genital warts or dysplasia in the last 3 months.I am currently taking 5 mg or more of prednisone daily.I am not taking aspirin or NSAIDs, except for low-dose aspirin for heart health.My tests show early-stage cervical cancer or pre-cancerous changes.I have no allergies or conditions that prevent me from taking IRX-2 regimen drugs.I understand the study rules and have signed the consent form.My diagnosis is either CIN 3 or VIN 3 (usual type).My hemoglobin level is at least 8 g/dL, even if I had a transfusion or took erythropoietin recently.My tests show early-stage cancer in my cervix or vulva.I haven't taken immunotherapy or investigational drugs in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (IRX-2)
- Group 2: Arm II (placebo)
Awards:
This trial has 1 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment cap for this clinical trial?
"Confirmed. According to the clinicaltrials.gov record, this research study is still recruiting participants after first being posted on November 8th 2017 and lastly revised in August 19th 2022. 60 volunteers are sought from two distinct locations for analysis."
Answered by AI
Is enrollment still open for this research investigation?
"This clinical trial is currently recruiting, according to data posted on the clinicaltrials.gov website. The study was initially published in November 2017 and was recently modified on August 19th 2022."
Answered by AI
Could you provide an overview of prior experiments involving IRX-2?
"At this time, 838 trials are studying IRX-2's efficacy and 157 of these experiments are in the phase 3 stage. Philadelphia is coincidentally where most of the clinical tests for this drug occur but research sites exist across 2793 different locations worldwide."
Answered by AI
Which medical conditions is IRX-2 usually prescribed to treat?
"IRX-2 is a potential solution for those suffering from inadequate response to conventional therapy, gastroesophageal reflux disease, and multiple sclerosis."
Answered by AI
What risks have been associated with the usage of IRX-2 in clinical settings?
"There is preliminary data demonstrating IRX-2's safety, so it was rated a 2. However, no research has yet been conducted to prove its efficacy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger