IRX-2 Regimen for Cervical Carcinoma

Recruiting at 1 trial location

Overseen By America Casillas-Lopez

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Immunotherapy, Corticosteroids, Aspirin, others

Disqualifiers: Pregnancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived biologic with multiple active cytokine components, may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.

Research Team

Lynda Roman, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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.

Inclusion Criteria

My total bilirubin levels are less than twice the upper limit, except if due to Gilbert's disease.

Activated partial thromboplastin time (aPTT) < 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN (upper limit of normal)

Exclusion Criteria

Known to be positive for human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody

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

I am allergic to ciprofloxacin or similar antibiotics.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cyclophosphamide and IRX-2 or placebo, along with indomethacin, zinc-containing multivitamins, and omeprazole for 21 days. Treatment repeats every 6 weeks for up to 2 courses.

12 weeks

Surgical Resection

Participants undergo surgical resection to assess pathologic response.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery.

1-8 weeks

Treatment Details

Interventions

• IRX-2

Trial Overview 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.

Participant Groups

Group I: Arm I (IRX-2) Experimental Treatment 7 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 Control 7 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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Brooklyn ImmunoTherapeutics, LLC

Industry Sponsor

Trials

8

Recruited

5,500+