Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Respiratory System Agents

All Drugs and Chemicals

Zafirlukast

Anti-Asthmatic Agents

Leukotriene Antagonists

Hormones

Hormone Antagonists

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

Oral tablets, 2x daily for 28 day cycle up to 1 year

Rushad Patell, MD

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

Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer

A Phase 2 Study of Zafirlukast for the Treatment of Tumor-marker Only Relapsed Ovarian Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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

Plasma D-dimer response will be calculated as a proportion of those patients with a decrease in D-dimer of \> 20% relative to baseline. Statistical differences will be analyzed using a paired t-test comparing baseline and C2D1 values.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Principal Investigator

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Nervous System Diseases

Breast Neoplasms

Contracture

Joint Diseases

Muscular Diseases

Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks.

zafirlukast

Standard of Care (no intervention)

Pamela N Munster, MD

A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be undergoing mastectomy with immediate tissue-expander reconstruction to determine whether treatment with zafirlukast (20mg PO BID) can reduce or prevent the development of capsular contracture.

A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be undergoing mastectomy with immediate tissue-expander reconstruction to determine whether treatment with zafirlukast (20mg PO BID) can reduce or prevent the development of capsular contracture.

Patients will be block randomized 1:1 into two cohorts: treatment with zafirlukast and the standard of care, or standard of care alone. Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to 5 half-lives of the drug. Patients will be seen every 1-2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture at every appointment. The day of surgery for their expander-implant exchange, their Baker classification will also be noted.

During expander-implant exchange, three representative sections of the expander capsule will be collected: medial, lateral and anterior capsule specimens. These specimens will be bisected; half will be sent to pathology and half will be collected by the Munster lab. Gross and microscopic determination of capsule thickness will be performed by the pathology department. The Munster lab will fix and stain the tissues to look for the presence of collagen, level of fibrosis and number of myofibroblasts. Fibrosis level and collagen presence will be determined by performing immunohistochemistry with a Trichrome stain of the tissues, as well as Western blot analysis with Collagen-1. Myofibroblasts will be detected using immunohistochemistry with commercially available antibodies.

Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial

Compare capsular thickness by gross and microscopic measurement at the time of expander-implant exchange in those treated with zafirlukast (20 mg PO BID) compared with standard of care.

Perform histologic analysis of the capsule specimens to compare overall fibrosis and collagen deposition between the zafirlukast and standard of care groups.

During expander-implant exchange, three representative sections of the expander capsule will be collected: medial, lateral and anterior capsule specimens. Gross and microscopic determination of capsule thickness will be performed by the pathology department. The Munster lab will fix and stain the tissues to look for the presence of collagen, level of fibrosis, and number of myofibroblasts. Fibrosis level and collagen presence will be determined by performing immunohistochemistry with a Trichrome stain of the tissues, as well as Western blot analysis with Collagen-1. Myofibroblasts will be detected using immunohistochemistry with commercially available antibodies.

The capsule tissue that is removed at the time of expander-implant exchange will be fixed and histologically assessed for the presence of fibroblasts and myofibroblasts.

University of California, San Francisco

Zafirlukast

zafirlukast: Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks.

Standard of Care (no intervention)

Standard of Care (no intervention): Standard of Care (no intervention)

Standard of Care (no Intervention)

Total

30-39

40-49

50-59

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Pamela Munster

No participants were analyzed due to a change in post-mastectomy reconstruction standard practice which implements pre-pectoral implants resulting in low accruals to the protocol. The study was closed prior to any measurements taken or histology analyzed as there would have been insufficient data to produce any statistically significant results.

Capsular Thickness

Histologic Analysis: Compare Capsular Thickness by Gross and Microscopic Measurement at the Time of Expander-implant Exchange in Those Treated With Zafirlukast (20 mg PO BID) Compared With Standard of Care

Appearance of Capsular Contracture

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer	NCT04339140	Ovarian Cancer	Zafirlukast	18 Years -	Beth Israel Deaconess Medical Center
Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer	NCT04339140	Ovarian Cancer	Zafirlukast	18 Years -	Beth Israel Deaconess Medical Center
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial	NCT02950480	Breast Cancer	zafirlukast Standard of Car...	18 Years - 89 Years	University of California, San Francisco
Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer	NCT04339140	Ovarian Cancer	Zafirlukast	18 Years -	Beth Israel Deaconess Medical Center
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial	NCT02950480	Breast Cancer	zafirlukast Standard of Car...	18 Years - 89 Years	University of California, San Francisco

Spots Global Cancer Trial Database for zafirlukast

Every month we try and update this database with for zafirlukast cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zafirlukast

Every month we try and update this database with for zafirlukast cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zafirlukast cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.