Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
NCT ID: NCT00005947
Last Updated: 2010-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
127 participants
INTERVENTIONAL
1999-11-30
2004-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
QUADRUPLE
Study Groups
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sipuleucel-T
sipuleucel-T
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
Placebo
Placebo
Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Interventions
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sipuleucel-T
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
Placebo
Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.
* Tumor progression after hormonal therapy.
* Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone (\< 50 ng/dL) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
* A subject is eligible if he initially responded to antiandrogen withdrawal (\> 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal.
* Subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
* ECOG Performance Status of 0 or 1.
* Life expectancy of at least 16 weeks.
* Adequate hematologic, renal, and liver function.
Exclusion Criteria
* Metastatic disease expected to be in need of radiation therapy within 4 months.
* Concurrent therapy with experimental agents.
* Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.
18 Years
MALE
No
Sponsors
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Dendreon
INDUSTRY
Responsible Party
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Dendreon Corporation
Principal Investigators
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Eric J. Small, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Sidney Kimmel Cancer Center
San Diego, 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
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Albany Regional Cancer Center
Albany, New York, 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
St. Luke's-Roosevelt Hospital
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
AKSM Clinical Research Corporation
Columbus, Ohio, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States
Abington Hematology Oncology Associates, Incorporated
Abington, Pennsylvania, United States
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, United States
Office of Guy Bernstein, M.D.
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
American Oncology Resources
Dallas, Texas, United States
Devine Tidewater Urology
Norfolk, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Hematology Oncology Northwest, P.C.
Tacoma, Washington, United States
Countries
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References
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Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. doi: 10.1002/cncr.24429.
Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. doi: 10.1200/JCO.2005.04.5252.
Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.
Other Identifiers
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DEN-D9901
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1789
Identifier Type: -
Identifier Source: secondary_id
D9901 CDR0000067868
Identifier Type: -
Identifier Source: org_study_id