Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: Placebo; Biological: sipuleucel-T

• Registration Number: NCT00005947
• Lead Sponsor: Dendreon

Brief Summary

Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer.

Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

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.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2000-07-05
• Study First Submitted QC: 2004-03-04
• Study First Posted: 2004-03-05
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Results First Submitted: 2010-05-28
• Status Verified: 2010-10
• Results First Submitted QC: 2010-10-08
• Last Update Submitted: 2010-10-08
• Results First Posted: 2010-11-01
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
sipuleucel-T	sipuleucel-T	-

Primary Outcome Measures

Name	Time	Method
Time to Objective Disease Progression	36 months from randomization	The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From randomization to 36 months	Overall Survival

Trial Locations

Locations (34)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

St. Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

Albany Regional Cancer Center; 🇺🇸 Albany, New York, United States

Cancer and Blood Institute of the Desert; 🇺🇸 Rancho Mirage, California, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

American Oncology Resources; 🇺🇸 Dallas, Texas, United States

University of Rochester Cancer Center; 🇺🇸 Rochester, New York, United States

Sidney Kimmel Cancer Center; 🇺🇸 San Diego, California, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Devine Tidewater Urology; 🇺🇸 Norfolk, Virginia, United States

New York Medical College; 🇺🇸 Valhalla, New York, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Earle A. Chiles Research Institute at Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

Eisenhower Medical Center; 🇺🇸 Rancho Mirage, California, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

Office of Glenn Tisman; 🇺🇸 Whittier, California, United States

Office of Barry S. Berman; 🇺🇸 Orlando, Florida, United States

Center for Medical Oncology; 🇺🇸 Garden City, New York, United States

St. Vincents Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

Albert Einstein Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States

St. Luke's-Roosevelt Hospital; 🇺🇸 New York, New York, United States

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States

AKSM Clinical Research Corporation; 🇺🇸 Columbus, Ohio, United States

Abington Hematology Oncology Associates, Incorporated; 🇺🇸 Abington, Pennsylvania, United States

Office of Guy Bernstein, M.D.; 🇺🇸 Bryn Mawr, Pennsylvania, United States

Bryn Mawr Urology; 🇺🇸 Bryn Mawr, Pennsylvania, United States

Saint Mary Regional Cancer Center; 🇺🇸 Langhorne, Pennsylvania, United States

North Penn Hospital; 🇺🇸 Lansdale, Pennsylvania, United States

Hematology/Oncology Associates of NE Pennsylvania, P.C.; 🇺🇸 Scranton, Pennsylvania, United States

Hematology Oncology Northwest, P.C.; 🇺🇸 Tacoma, Washington, United States

Cancer Care Northwest; 🇺🇸 Spokane, Washington, United States