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ACTIVE NOT RECRUITING
NCT03012100
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Cyclophosphamide

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Multi-epitope Folate Receptor Alpha Peptide Vaccine

Given ID

OTHER

Placebo Administration

Given ID

BIOLOGICAL

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