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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

Must not have

Impaired hepatic, renal or hematological function, evidenced by: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >= 2 times upper limit of normal (ULN), Serum creatinine >= 2 times ULN, or Clinically significant active cardiovascular disease, including a history of myocardial infarction within the past 6 months, heart failure as defined by New York Heart Association classes III or IV, and/or blood pressure greater than 160/90 mm Hg (1 repeat measure allowed no more than 5 minutes after the first measurement)

Donation or loss of > 450 mL of blood or plasma within 30 days of randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 25

Awards & highlights

Approved for 40 Other Conditions

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.

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.

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 below

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My diagnosis is either CIN 3 or VIN 3 (usual type).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not donated or lost more than 450 mL of blood in the last month.

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I am allergic to ciprofloxacin or similar antibiotics.

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I am currently taking 5 mg or more of prednisone daily.

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I am not taking aspirin or NSAIDs, except for low-dose aspirin for heart health.

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My tests show early-stage cervical cancer or pre-cancerous changes.

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I have no allergies or conditions that prevent me from taking IRX-2 regimen drugs.

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My tests show early-stage cancer in my cervix or vulva.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic response

Secondary study objectives

Incidence of adverse events of IRX-2 administration

Side effects data

From 2012 Phase 2 trial • 27 Patients • NCT00210470

30%

HEADACHE

22%

INJECTION SITE PAIN

22%

NAUSEA

15%

CONSTIPATION

15%

DIZZINESS

11%

FATIGUE

11%

PNEUMONIA ASPIRATION

11%

ANAEMIA

11%

ASPIRATION PNEUMONIA

DRY MOUTH

VOMITING

MYALGIA

CONTUSION

INJECTION SITE DISCOMFORT

RESPIRATORY INFECTION

NECK ABSCESS

POSTOPERATIVE INFECTION

ALCOHOL WITHDRAWAL

100%

80%

60%

40%

20%

Study treatment Arm

IRX-2 Regimen

Awards & Highlights

Approved for 40 Other Conditions

This treatment demonstrated efficacy for 40 other conditions.

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

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9630

Omeprazole

FDA approved

Cyclophosphamide

FDA approved