Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

February 23, 2007

Primary Completion Date

April 27, 2017

Study Completion Date

June 8, 2017

Conditions
Prostate Cancer
Interventions
DRUG

Sargramostim (GM-CSF, Leukine)

A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant deoxyribonucleic acid (DNA) technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression of the protein in yeast.

DRUG

Flutamide (Eulexin)

Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex.

BIOLOGICAL

PROSTVAC-F/ TRICOM

A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three costimulatory molecules.

BIOLOGICAL

PROSTVAC-V/TRICOM

A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.

Trial Locations (3)

19111

Fox Chase Cancer Center, Philadelphia

20892

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

08901

Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00450463 - Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer | Biotech Hunter | Biotech Hunter