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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: November 5, 2009   History of Changes
Sponsor: Dendreon
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005947
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Biological: prostatic acid phosphatase-sargramostim fusion protein
Biological: sipuleucel-T
Procedure: in vitro-treated peripheral blood stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven hormone refractory adenocarcinoma of the prostate that is asymptomatic Must have soft tissue and/or bony metastases No visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites) At least 25% of tumor cells staining positive for prostatic acid phosphatase by immunohistochemistry PSA at least 5 ng/mL Tumor progression after hormonal therapy No cancer related pain and no regular requirement for analgesics

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: At least 16 weeks Hematopoietic: WBC at least 2,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) ALT and AST no greater than 5 times ULN Hepatitis B surface antigen and hepatitis C antibody negative Renal: Creatinine no greater than 2.0 mg/dL Other: HIV1, HIV2, and HTLV-1 negative No active bacterial, viral, or fungal infection No other malignancy except: Basal cell or squamous cell skin cancer within the past 3 years OR Stage I or II other cancers within the past 5 years No psychologic, familial, sociologic, geographic, or other medical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No more than 1 prior chemotherapy regimen Endocrine therapy: See Disease Characteristics More than 1 year since prior corticosteroids except replacement systemic steroids and inhaled, intranasal, or topical corticosteroids No concurrent antiandrogen therapy Concurrent LHRH agonists allowed Radiotherapy: No prior radiopharmaceutical therapy At least 4 weeks since other prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: No concurrent herbal therapy Concurrent bisphosphonates allowed if started at least 30 days before enrollment and continued for duration of study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005947

  Hide Study Locations
Locations
United States, California
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States, 92270
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Office of Glenn Tisman
Whittier, California, United States, 90601
Sidney Kimmel Cancer Center
San Diego, California, United States, 92121
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Florida
Office of Barry S. Berman
Orlando, Florida, United States, 32806
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Center for Medical Oncology
Garden City, New York, United States, 11530
New York Medical College
Valhalla, New York, United States, 10595
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
St. Luke's-Roosevelt Hospital
New York, New York, United States, 10019
St. Vincents Comprehensive Cancer Center
New York, New York, United States, 10011
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, Ohio
AKSM Clinical Research Corporation
Columbus, Ohio, United States, 43214
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Abington Hematology Oncology Associates, Incorporated
Abington, Pennsylvania, United States, 19001
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, United States, 19010
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, United States, 18510
North Penn Hospital
Lansdale, Pennsylvania, United States, 19446-1200
Office of Guy Bernstein, M.D.
Bryn Mawr, Pennsylvania, United States, 19010
Saint Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
United States, Texas
American Oncology Resources
Dallas, Texas, United States, 75246
United States, Virginia
Devine Tidewater Urology
Norfolk, Virginia, United States, 23507
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99202
Hematology Oncology Northwest, P.C.
Tacoma, Washington, United States, 98405
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Dendreon
Investigators
Study Chair: Eric J. Small, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067868, DEN-D9901, NCI-G00-1789
Study First Received: July 5, 2000
Last Updated: November 5, 2009
ClinicalTrials.gov Identifier: NCT00005947     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009