A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
Objectives:
I. Compare the time to progression, time to development of disease-related pain, and
incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic
metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus
control infusion. II. Compare response rate and duration of response in these patients.
Outline: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4.
Patients receive APC8015 comprised of ADCP activated with prostatic acid
phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after
each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients
receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total
of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective
disease progression. Patients are followed monthly for up to 3 years or until disease
progression. At the time of disease progression, patients treated on arm II may receive
treatment on Protocol D9903.
Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued
for this study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to Objective Disease Progression
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
36 months from randomization
Yes
Eric J. Small, MD
Study Chair
University of California, San Francisco
United States: Food and Drug Administration
D9901 CDR0000067868
NCT00005947
November 1999
September 2004
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Rochester Cancer Center | Rochester, New York 14642 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
New York Medical College | Valhalla, New York 10595 |
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
Albany Regional Cancer Center | Albany, New York 12208 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Sidney Kimmel Cancer Center | San Diego, California 92121 |
Eisenhower Medical Center | Rancho Mirage, California 92270 |
Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
St. Vincents Comprehensive Cancer Center | New York, New York 10011 |
North Penn Hospital | Lansdale, Pennsylvania 19446-1200 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
St. Luke's-Roosevelt Hospital | New York, New York 10019 |
Saint Mary Regional Cancer Center | Langhorne, Pennsylvania 19047 |
Hematology/Oncology Associates of NE Pennsylvania, P.C. | Scranton, Pennsylvania 18510 |
Office of Glenn Tisman | Whittier, California 90601 |
Office of Barry S. Berman | Orlando, Florida 32806 |
Center for Medical Oncology | Garden City, New York 11530 |
AKSM Clinical Research Corporation | Columbus, Ohio 43214 |
Abington Hematology Oncology Associates, Incorporated | Abington, Pennsylvania 19001 |
Bryn Mawr Urology | Bryn Mawr, Pennsylvania 19010 |
Office of Guy Bernstein, M.D. | Bryn Mawr, Pennsylvania 19010 |
American Oncology Resources | Dallas, Texas 75246 |
Devine Tidewater Urology | Norfolk, Virginia 23507 |
Cancer Care Northwest | Spokane, Washington 99202 |
Hematology Oncology Northwest, P.C. | Tacoma, Washington 98405 |