153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Prostate Cancer
Interventions
RADIATION

Samarium Sm 153 lexidronam pentasodium

1 mCi/Kg given intravenous (IV)over 1 minute on day 8.

BIOLOGICAL

Sargramostim

100 mcg/injection x 4 days given subcutaneously

BIOLOGICAL

Recombinant vaccinia-TRICOM vaccine

2 x 10\^8 PFU given subcutaneously on day 1.

BIOLOGICAL

Recombinant fowlpox-TRICOM vaccine

1 x 10\^9 PFU given subcutaneously on days 15 and 29

Trial Locations (3)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

60637

University of Chicago, Chicago

08901

Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00450619 - 153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer | Biotech Hunter | Biotech Hunter