IRX-2 Regimen for Cervical Carcinoma

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the IRX-2 Regimen, an immunotherapy, to determine if it can boost the immune system in women with severe cervical or vulvar lesions, specifically cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The treatment combines medications and supplements to support the body's defenses against these conditions. Participants will receive either the active treatment or a placebo to compare effectiveness. Women diagnosed with these specific lesions who are not currently pregnant or breastfeeding might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you should not take aspirin (except low-dose for vascular disease) or other non-prescribed anti-inflammatory drugs during the trial. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the IRX-2 treatment has been tested in cervical cancer and other types of cancer, yielding promising safety results. In a study with cervical cancer patients, most participants tolerated IRX-2 well and did not experience severe side effects. Another study with head and neck cancer patients found that IRX-2 was safe and helped reduce symptoms like pain and difficulty swallowing.

Overall, these studies suggest that IRX-2 is generally well-tolerated, which is encouraging for those considering participation in a clinical trial for this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cervical carcinoma, which often involve surgery, radiation, and chemotherapy, IRX-2 offers a novel approach by using an immune-modulating regimen. This treatment includes submucosal injections of IRX-2 directly into the cervix, aiming to enhance the body’s immune response against the cancer cells. Researchers are particularly excited about IRX-2 because it potentially targets the tumor environment more precisely, which may lead to better outcomes and fewer side effects compared to traditional therapies. Additionally, the inclusion of supportive medications like indomethacin and zinc-containing multivitamins may further enhance the immune response, providing a comprehensive strategy against the disease.

What evidence suggests that the IRX-2 Regimen might be an effective treatment for cervical carcinoma?

Research shows that IRX-2, a treatment derived from human cells, can help the immune system combat cancer. In earlier studies, IRX-2 reduced the size of cervical cancer tumors. It enhances the body's natural ability to attack cancer by improving T-cells, which are crucial for identifying and destroying cancer cells. In this trial, some participants will receive IRX-2, while others will receive a placebo. Early research found that patients who received IRX-2 responded well, suggesting it might effectively treat cervical and vulvar lesions. This treatment aims to strengthen the immune system, potentially leading to better outcomes for patients with these conditions. ^{1 2 6 7 8}

Who Is on the Research Team?

Lynda Roman, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6029613/

IRX-2 natural cytokine biologic for immunotherapy in patients ... The results of this pilot study provisionally support the ability of IRX-2 to induce tumor responses in cervical cancer.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1567576902000486

A pilot study of perilymphatic leukocyte cytokine mixture ... The objective of this study was to evaluate the antitumor activity and toxicity of IRX-2 in untreated early stage cervical cancer patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02609386

Study Details | NCT02609386 | IRX-2 Regimen in Patients ... This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/26/7/1595/83166/A-Phase-Ib-Study-of-Preoperative-Locoregional-IRX

A Phase Ib Study of Preoperative, Locoregional IRX-2 ... Finally, IRX-2 was shown to be most effective when administered repeatedly for up to 10 doses, leading to the development of a clinical regimen that includes 10 ...

5. nature.com nature.com/articles/cdd2008197

IRX-2, a novel immunotherapeutic, protects human T cells ... These data suggest that the promising clinical effects of IRX-2 are the result of more effective antitumor T-cell responses. The objective of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03267680?cond=%22Cervical%20Squamous%20Cell%20Carcinoma%22&intr=%22Tocolytic%20Agents%22&viewType=Table&rank=1

IRX-2 Regimen in Treating Women With Cervical ... This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous ...

7. researchgate.net researchgate.net/publication/44664654_A_Phase_1_Safety_Study_of_an_IRX-2_Regimen_in_Patients_With_Squamous_Cell_Carcinoma_of_the_Head_and_Neck?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

A Phase 1 Safety Study of an IRX-2 Regimen in Patients ... The delivery of IRX-2 to tumor-draining lymph nodes (LN) of HNC patients reduced pain and dysphagia, decreased tumor size and, in some patients, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20539208/

A phase 1 safety study of an IRX-2 regimen in patients with ... Conclusions: The IRX-2 regimen was tolerated in patients with advanced HNSCC who failed surgery and/or radiation therapy. The safety and antitumor activity ...