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Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Sponsor: Academic and Community Cancer Research United
Summary
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.
Official title: Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2017-03-31
Completion Date
2026-07-31
Last Updated
2023-01-13
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
Given PO
Laboratory Biomarker Analysis
Correlative studies
Multi-epitope Folate Receptor Alpha Peptide Vaccine
Given ID
Placebo Administration
Given ID
Sargramostim
Given ID
Locations (12)
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States