A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With Prostate-Specific Antigen (PSA) Progression After Local Therapy for Prostate Cancer
- To evaluate the effect of PROSTVAC-V/TRICOM (Vaccinia) on cycle 1 followed by
PROSTVAC-F/TRICOM (Fowlpox) and GM-CSF on biochemical PSA progression at 6 months.
- To determine the change in PSA velocity pre-treatment to post-treatment.
- To evaluate the percentage of patients experiencing a >50% decline in serum PSA
repeated at 4 weeks.
- To evaluate tolerability and any toxicity related to treatment with PSA vaccine and
- To determine the effect of GM-CSF on PSA immediately after treatment (day 4) compared
to a delayed effect (day 15).
OUTLINE: This is a multicenter study.
Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim
(GM-CSF) SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive
fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with
fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 2 courses (weeks 5 and 9).
Beginning in week 13, patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every
12 weeks in the absence of clinical or biochemical disease progression or unacceptable
Patients with biochemical or clinical disease progression may start androgen ablation
therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4
weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF. Treatment continues in the
absence of further clinical or biochemical disease progression.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually for 10 years.
ACTUAL ACCRUAL: A total of 50 patients were accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)
For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater. Changes in PSA below 5 ng/mL will not be considered assessable for progression. For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL.
Assessed at 6 months
Robert S. DiPaola, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|McCreery Cancer Center at Ottumwa Regional||Ottumwa, Iowa 52501|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Hematology Oncology Associates - Skokie||Skokie, Illinois 60076|
|Mercy Hospital and Medical Center||Chicago, Illinois 60616|
|Hematology and Oncology Associates||Chicago, Illinois 60611|
|Midwest Center for Hematology/Oncology||Joliet, Illinois 60432|
|Hematology/Oncology of the North Shore at Gross Point Medical Center||Skokie, Illinois 60076|
|Cancer Care and Hematology Specialists of Chicagoland - Niles||Niles, Illinois 60714|