This research study is evaluating the effectiveness of Zafirlukast to prevent tumor activity in participants with tumor marker-only relapsed ovarian cancer. * The name of the study drug involved in this study is: * Zafirlukast
This is a single-arm Simon two-stage phase 2 clinical trial to determine whether zafirlukast reduces the tumor marker CA-125 as well the tendency to form blood clots in tumor marker-only relapsed ovarian cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * The name of the study drug involved in this study is: * Zafirlukast Eligible participants will receive study treatment for up to 1 year and will be followed for up to one year following treatment. It is expected that about 30 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved zafirlukast for this specific disease but it has been approved for other uses. Zafirlukast is currently approved to be used for the treatment of asthma. It has been recently learned that Zakfirlukast demonstrates anti-tumor activity in laboratory studies of ovarian cancer. This means that these results were not found in humans. The National Institutes of Health are supporting this research study by providing funding
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Oral tablets, 2x daily for 28 day cycle up to 1 year
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CA-125 Response Rate
Response will be defined according to GCIG criteria which requires a reduction of CA-125 of \> 50% relative to pre-treatment CA-125 level, maintained for at least 28 days
Time frame: 84 days
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