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To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715078
First Posted: July 15, 2008
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dendreon
  Purpose
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen

Condition Intervention Phase
Prostate Cancer Biological: sipuleucel-T Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. [ Time Frame: Baseline, Months 2, 4 and 6. ]
    An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.


Enrollment: 122
Study Start Date: October 2008
Study Completion Date: May 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort A
Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
Active Comparator: Cohort B
Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
Active Comparator: Cohort C
Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Detailed Description:
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

  • Histologically documented adenocarcinoma of the prostate.
  • Metastatic disease.
  • Progressive androgen independent castrate resistant prostate cancer.
  • Serum PSA ≥ 5.0 ng/mL.
  • Life expectancy of ≥ 6 months.
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
  • Men ≥ 18 years of age.
  • Adequate hematologic, renal and liver function.

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following criteria apply.

  • The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
  • A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.
  • Moderate to severe disease related pain.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
  • Use of non-steroidal antiandrogens within 6 weeks of registration.
  • Anti-androgen withdrawal response.
  • Treatment with chemotherapy within 3 months of registration.
  • More than 2 chemotherapy regimens prior to registration.
  • Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.
  • Treatment with any of the following medications or interventions within 28 days of registration:

    • Systemic corticosteroids,
    • External beam radiation therapy or surgery,
    • Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto,
    • Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
    • 5-alpha-reductase inhibitors,
    • High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day).
  • Any other systemic therapy for prostate cancer (except for medical castration).
  • Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
  • Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
  • Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
  • A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
  • A requirement for systemic immunosuppressive therapy for any reason.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or granulocyte-macrophage colony-stimulating factor.
  • Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
  • Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715078


Locations
United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0820
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, District of Columbia
Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20007
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Providence Medical Center
Portland, Oregon, United States, 97213
Kaiser Permanente
Portland, Oregon, United States, 97227
Northwest Cancer Specialists
Portland, Oregon, United States, 97227
United States, Virginia
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, United States, 23503
United States, Washington
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98102
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
  More Information

Additional Information:
Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00715078     History of Changes
Other Study ID Numbers: P07-2
First Submitted: July 11, 2008
First Posted: July 15, 2008
Results First Submitted: February 19, 2014
Results First Posted: May 12, 2014
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dendreon:
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
prostate specific antigen (PSA)
prostatic adenocarcinoma

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