A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Recurrent Prostate CarcinomaStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate CancerStage III Prostate Cancer
Interventions
DRUG

Bicalutamide

Given orally

DRUG

Goserelin Acetate

Given SC

BIOLOGICAL

Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine

Given SC

BIOLOGICAL

Recombinant Vaccinia-TRICOM Vaccine

Given SC

BIOLOGICAL

Sargramostim

Given SC

Trial Locations (7)

10016

New York University Langone Medical Center, New York

32207

Baptist Cancer Institute, Jacksonville

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

60611

Northwestern University, Chicago

02215

Beth Israel Deaconess Medical Center, Boston

Eastern Cooperative Oncology Group, Boston

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00108732 - A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer | Biotech Hunter | Biotech Hunter