Zafirlukast for Ovarian Cancer

Overseen By Rushad Patell, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticoagulants, Aspirin, CYP2C9 inhibitors

Disqualifiers: Non-epithelial tumors, Brain metastases, 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: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Zafirlukast, a leukotriene receptor antagonist, for individuals with a specific type of relapsed ovarian cancer. The researchers aim to determine if Zafirlukast can prevent tumors from becoming active again. Those with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, whose tumor markers have increased after initial treatment, may find this trial suitable. Participants must have completed chemotherapy and surgery and be able to swallow tablets. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take anticoagulants, certain doses of aspirin, or medications that affect the CYP2C9 enzyme. It's important to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that Zafirlukast is likely to be safe for humans?

Research has shown that Zafirlukast is usually well-tolerated when used for other conditions. The FDA has approved it for treating asthma, providing doctors with a good understanding of its safety.

While specific safety information about using Zafirlukast for ovarian cancer is limited, earlier studies found that it can significantly slow tumor growth in lab tests. This is encouraging, but it's important to remember that lab results don't always apply directly to people.

This trial is in an early stage, focusing mainly on safety and how well people tolerate Zafirlukast. Researchers are closely monitoring for any side effects to ensure the treatment is safe enough for further testing. Participants will be carefully observed for any adverse reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which often include surgery and chemotherapy, Zafirlukast offers a novel approach by targeting inflammation pathways. Most treatments directly attack cancer cells, but Zafirlukast, originally used for asthma, blocks leukotrienes that may play a role in cancer progression. Researchers are excited because this unique mechanism could provide a new angle in fighting ovarian cancer, potentially with fewer side effects than traditional therapies.

What evidence suggests that Zafirlukast might be an effective treatment for ovarian cancer?

Research has shown that Zafirlukast, a medication originally used for asthma, may help reduce tumor growth in ovarian cancer. Studies found that it significantly slowed tumor growth and decreased cancer cell activity in lab tests. Zafirlukast affects certain enzymes, which can shrink tumors and slow cancer spread. It also reduces the activity of a pathway often linked to cancer growth. These findings suggest it might be useful in treating ovarian cancer. Participants in this trial will receive Zafirlukast to further evaluate its effectiveness in this context. ^{1 2 3 4 6}

Who Is on the Research Team?

Rushad Patell, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adult women with a specific type of ovarian cancer that has relapsed, indicated only by tumor markers without visible disease. They must have finished initial chemotherapy and surgery successfully, be able to swallow pills, and use contraception if childbearing potential. Men and those with certain health conditions or on conflicting medications are excluded.

Inclusion Criteria

My CA-125 levels have doubled without signs of cancer on scans.

I've completed initial chemotherapy and surgery for my cancer without it getting worse.

I can swallow pills.

Exclusion Criteria

I have side effects from cancer treatment, but they are mild except for hair loss or nerve issues.

I am not pregnant or breastfeeding.

I am currently on blood thinner medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zafirlukast orally at a pre-determined dose 2x daily for 28-day cycles up to 1 year

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Zafirlukast

Trial Overview The study tests Zafirlukast's effectiveness in preventing tumor activity in women whose ovarian cancer has returned but is only detectable through tumor markers rather than physical tumors. Participants will take Zafirlukast tablets to see if it can control the cancer's return.

How Is the Trial Designed?

Group I: Zafirlukast Experimental Treatment 1 Intervention

Zafirlukast will be taken orally at a pre-determined dose 2x daily for 28 day cycle up to 1 year.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10360043/

Targeting thiol isomerase activity with zafirlukast to treat ... Zafirlukast significantly inhibited tumor growth in a xenograft model of ovarian cancer, which is consistent with previous studies of thiol isomerase ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04339140

Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer This research study is evaluating the effectiveness of Zafirlukast to prevent tumor activity in participants with tumor marker-only relapsed ovarian cancer. The ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04339140/zafirlukast-in-treatment-of-marker-relapsed-ovarian-cancer

Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer This research study is evaluating the effectiveness of Zafirlukast to prevent tumor activity in participants with tumor marker-only relapsed ...

4. faseb.onlinelibrary.wiley.com faseb.onlinelibrary.wiley.com/doi/full/10.1096/fj.202201952R

Targeting thiol isomerase activity with zafirlukast to treat ... Decreases in cancer cell growth, decreased activation of the EGFR pathway, decreases in tumor size, and metastasis in a xenograft model alone ...

5. withpower.com withpower.com/trial/phase-3-carcinoma-ovarian-epithelial-5-2020-4f7d3

Zafirlukast for Ovarian Cancer · Info for Participants The drug may reduce tumor activity and lower the risk of blood clots based on lab studies. Zafirlukast is commonly used to improve asthma control. Show more ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/40/NCT04339140/Prot_SAP_000.pdf

A phase 2 study of zafirlukast for the treatment of tumor- ... These data suggest that higher doses of zafirlukast may provide additional PDI inhibitory activity and further inhibit ovarian cancer cell growth.