Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer
OBJECTIVES: I. Evaluate the effect of prime and boost strategies using recombinant fowlpox
prostate specific antigen (PSA) vaccine and recombinant vaccinia PSA vaccine on biochemical
PSA progression in patients with stage D0 prostate cancer who have completed local
treatment. II. Assess the tolerability and toxicity of these prime and boost treatment
regimens in these patients. III. Evaluate the effects of these prime and boost treatment
regimens on cellular immunity in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to HLA-2 typing
(positive vs negative vs unknown). Patients are randomized to one of three treatment arms.
Arm I: Patients receive intramuscular fowlpox prostate specific antigen (PSA) vaccine at
weeks 0, 6, 12, and 18. Arm II: Patients receive intramuscular fowlpox PSA vaccine at weeks
0, 6, and 12 and intradermal vaccinia PSA vaccine at week 18. Arm III: Patients receive
intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6,
12, and 18. Patients are followed at week 24, then every 3 months until year 2, every 6
months until year 5, and annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Howard L. Kaufman, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Food and Drug Administration
CDR0000067036
NCT00003871
August 1999
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |