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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Zafirlukast, an asthma medication, to see if it can help patients with relapsed ovarian cancer. 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.

Research Team

Rushad Patell, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+