Vaccine Therapy With or Without Cyclophosphamide and Doxorubicin in Women With Stage IV Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

August 31, 2008

Conditions
Breast Cancer
Interventions
BIOLOGICAL

allogeneic GM-CSF-secreting breast cancer vaccine

The first three patients will receive a dose of 5 X 107 cells, and the next three will receive a dose of 5 X 108 cells. Then, if these two doses of vaccine alone are found to be safe, a fixed vaccine dose of 5 X 108 cells will be tested in combination with chemotherapy based on the safety of the allogeneic breast vaccine alone and the safety and bioactivity of a dose of 5 X 108 cells in the allogeneic pancreatic vaccine trial

DRUG

cyclophosphamide

This trial will be a dose ranging study of a fixed sequence of drug doses in a three by three factorial matrix modeled after the theories of Plackett and Burman (Plackett et al., 1946), and is designed to determine the doses of CY and DOX that maximize the immunologic response to vaccination

DRUG

doxorubicin hydrochloride

This trial will be a dose ranging study of a fixed sequence of drug doses in a three by three factorial matrix modeled after the theories of Plackett and Burman (Plackett et al., 1946), and is designed to determine the doses of CY and DOX that maximize the immunologic response to vaccination

Trial Locations (1)

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT00093834 - Vaccine Therapy With or Without Cyclophosphamide and Doxorubicin in Women With Stage IV Breast Cancer | Biotech Hunter | Biotech Hunter